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Ibuprofen

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Ibuprofen
Generic name
Ibuprofen
Dosage form
Tablet, Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Shield Pharmaceuticals Corp
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
5
NDC product codes
88
Packages
174
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Ibuprofen 200 mg/1 310965 View
Ibuprofen 300 mg/1 310965 View
Ibuprofen 400 mg/1 310965 View
Ibuprofen 600 mg/1 310965 View
Ibuprofen 800 mg/1 310965 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Coated
Route of administration
Oral
Presentations
262

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Anti-Inflammatory Agents EPC All 251 members
Cyclooxygenase Inhibitors [MoA] MoA All 251 members
Non-Steroidal [CS] CS All 251 members
Nonsteroidal Anti-inflammatory Drug [EPC] EPC All 251 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
202312
Application type
ANDA · Abbreviated New Drug Application
Approval date
October 7, 2016
Sponsor
GRANULES
Products on application
1
Submissions recorded
1
Products approved under application 202312.
Product Trade name Form Strength Ingredient Status TE Flags
202312-001 IBUPROFEN TABLET IBUPROFEN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 202312.
Type No. Action Status Date Review
Original application 1 Approved October 7, 2016 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260902). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260902 HUMAN OTC DRUG · 20260902 HUMAN OTC DRUG · 20250128 HUMAN OTC DRUG · 20241206

Boxed Warning

openFDA Drug Labeling

Important: Read all product information before using. Keep the box for important information.

Indications and Usage

openFDA Drug Labeling

Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ minor pain of arthritis ■ toothache ■ backache ■ the common cold ■ menstrual cramps ■ temporarily reduces fever

Purpose Pain reliever/fever reducer

Purposes Pain reliever/fever reducer

Dosage and Administration

openFDA Drug Labeling

Directions do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) adults and children 12 years and over take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years ask a doctor

Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock rash blisters skin reddening If an allergic reaction occurs, stop use an seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or oder have had stomach ulcers or bleeding problems take blood thinning (anticoagulant) or steroid drug take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) take more or for a longer time than directed. have 3 or more alcoholic drinks every day while using this prdouct Do not use if you ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic. Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug. When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed. Stop use and ask a doctor if You experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or last more than 10 days fever gets worse or last more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222) Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and older: take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years : ask a doctor Other information store between 20 o - 25 o C (68 o - 77 o F)

Do not use ■ if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer ■ right before or after heart surgery

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ the stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke ■ you are taking a diuretic

Stop use and ask a doctor if ■ side effects occur. You may report side effects to FDA at 1-800-FDA-1088. ■ you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better ■ you have symptoms of heart problems or stroke: ■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present in the painful area ■ any new symptoms appear

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each Orange tablet or caplet ** ) Ibuprofen 200 mg (NSAID) * * nonsteroidal anti-inflammatory drug **capsule-shaped tablets

Adverse event reports

Source: openFDA FAERS
283,546
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: IBUPROFEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
57344-109-03 57344-109 AAA Pharmaceutical, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (57344-109-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC October 1, 2012
57344-109-05 57344-109 AAA Pharmaceutical, Inc. 500 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-109-05) May 1, 2019
57344-110-01 57344-110 AAA Pharmaceutical, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (57344-110-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC July 1, 2017
57344-309-03 57344-309 AAA Pharmaceutical, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (57344-309-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC June 17, 2025
57344-309-15 57344-309 AAA Pharmaceutical, Inc. 250 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-309-15) December 5, 2024
57344-811-03 57344-811 AAA Pharmaceutical, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (57344-811-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC February 1, 2020
61504-109-03 61504-109 AMERIFOODS TRADING COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (61504-109-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC October 30, 2023
61504-109-05 61504-109 AMERIFOODS TRADING COMPANY 500 TABLET, COATED in 1 BOTTLE, PLASTIC (61504-109-05) October 30, 2023
61504-110-03 61504-110 AMERIFOODS TRADING COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (61504-110-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC October 30, 2023
21130-358-05 21130-358 BETTER LIVING BRANDS LLC. 50 TABLET, COATED in 1 BOTTLE (21130-358-05) July 12, 2019
21130-358-10 21130-358 BETTER LIVING BRANDS LLC. 100 TABLET, COATED in 1 BOTTLE (21130-358-10) June 30, 2023
21130-358-50 21130-358 BETTER LIVING BRANDS LLC. 500 TABLET, COATED in 1 BOTTLE (21130-358-50) July 12, 2019
21130-359-05 21130-359 BETTER LIVING BRANDS LLC. 50 TABLET, COATED in 1 BOTTLE (21130-359-05) August 1, 2020
21130-359-10 21130-359 BETTER LIVING BRANDS LLC. 100 TABLET, COATED in 1 BOTTLE (21130-359-10) August 1, 2020
63868-268-25 63868-268 CHAIN DRUG MARKETING ASSOCIATION INC 250 TABLET, COATED in 1 BOTTLE, PLASTIC (63868-268-25) May 31, 2021
63868-570-01 63868-570 CHAIN DRUG MARKETING ASSOCIATION INC 1 BOTTLE, PLASTIC in 1 CARTON (63868-570-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC May 15, 2020
63868-570-50 63868-570 CHAIN DRUG MARKETING ASSOCIATION INC 1 BOTTLE, PLASTIC in 1 CARTON (63868-570-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC March 25, 2020
63868-571-01 63868-571 CHAIN DRUG MARKETING ASSOCIATION INC 1 BOTTLE, PLASTIC in 1 CARTON (63868-571-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC May 15, 2020
63868-571-50 63868-571 CHAIN DRUG MARKETING ASSOCIATION INC 1 BOTTLE, PLASTIC in 1 CARTON (63868-571-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC March 25, 2020
83324-100-01 83324-100 CHAIN DRUG MARKETING ASSOCIATION, INC. 1 BOTTLE, PLASTIC in 1 CARTON (83324-100-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC May 15, 2025
83324-100-50 83324-100 CHAIN DRUG MARKETING ASSOCIATION, INC. 1 BOTTLE, PLASTIC in 1 CARTON (83324-100-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC May 15, 2025
83324-101-25 83324-101 CHAIN DRUG MARKETING ASSOCIATION, INC. 250 TABLET, COATED in 1 PACKAGE (83324-101-25) May 8, 2025
83324-102-01 83324-102 CHAIN DRUG MARKETING ASSOCIATION, INC. 1 BOTTLE, PLASTIC in 1 CARTON (83324-102-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC May 15, 2025
83324-102-50 83324-102 CHAIN DRUG MARKETING ASSOCIATION, INC. 1 BOTTLE, PLASTIC in 1 CARTON (83324-102-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC May 15, 2025
69842-489-34 69842-489 CVS Pharmacy.Inc. 225 TABLET, COATED in 1 BOTTLE (69842-489-34) December 18, 2021
53943-111-02 53943-111 DISCOUNT DRUG MART 1 BOTTLE, PLASTIC in 1 CARTON (53943-111-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC March 1, 2020
53943-111-03 53943-111 DISCOUNT DRUG MART 1 BOTTLE, PLASTIC in 1 CARTON (53943-111-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC March 1, 2020
53943-111-05 53943-111 DISCOUNT DRUG MART 500 TABLET, COATED in 1 BOTTLE, PLASTIC (53943-111-05) March 1, 2020
53943-111-08 53943-111 DISCOUNT DRUG MART 225 TABLET, COATED in 1 BOTTLE, PLASTIC (53943-111-08) March 1, 2020
53943-112-02 53943-112 DISCOUNT DRUG MART 1 BOTTLE, PLASTIC in 1 CARTON (53943-112-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC March 1, 2020
53943-112-03 53943-112 DISCOUNT DRUG MART 1 BOTTLE, PLASTIC in 1 CARTON (53943-112-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC March 1, 2020
53943-112-08 53943-112 DISCOUNT DRUG MART 225 TABLET, COATED in 1 BOTTLE, PLASTIC (53943-112-08) March 1, 2020
55910-901-42 55910-901 DOLGENCORP INC 24 TABLET, COATED in 1 BOTTLE (55910-901-42) December 9, 2019
53942-112-03 53942-112 Demoulas Super Markets, Inc 1 BOTTLE, PLASTIC in 1 CARTON (53942-112-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC July 16, 2025
55910-768-24 55910-768 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 1 BOTTLE, PLASTIC in 1 BOX (55910-768-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC April 30, 2017
75907-428-05 75907-428 Dr. Reddy's Laboratories Inc. 500 TABLET, COATED in 1 BOTTLE (75907-428-05) July 1, 2026
81522-119-03 81522-119 FSA STORE INC. 1 BOTTLE, PLASTIC in 1 CARTON (81522-119-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC May 3, 2023
81522-119-05 81522-119 FSA STORE INC. 500 TABLET, COATED in 1 BOTTLE, PLASTIC (81522-119-05) January 11, 2023
55319-136-05 55319-136 Family Dollar (FAMILY WELLNESS) 500 TABLET, COATED in 1 BOTTLE, PLASTIC (55319-136-05) August 31, 2023
55319-136-24 55319-136 Family Dollar (FAMILY WELLNESS) 1 BOTTLE, PLASTIC in 1 BOX (55319-136-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC August 31, 2023
55319-137-02 55319-137 Family Dollar (FAMILY WELLNESS) 1 BOTTLE in 1 BOX (55319-137-02) / 200 TABLET, COATED in 1 BOTTLE July 30, 2023
55319-137-10 55319-137 Family Dollar (FAMILY WELLNESS) 1 BOTTLE, PLASTIC in 1 BOX (55319-137-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC July 30, 2023
55319-137-50 55319-137 Family Dollar (FAMILY WELLNESS) 1 BOTTLE, PLASTIC in 1 BOX (55319-137-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC July 30, 2023
55319-252-05 55319-252 Family Dollar (FAMILY WELLNESS) 500 TABLET, COATED in 1 BOTTLE (55319-252-05) September 15, 2023
55319-252-10 55319-252 Family Dollar (FAMILY WELLNESS) 1 BOTTLE, PLASTIC in 1 BOX (55319-252-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC September 15, 2023
55319-252-24 55319-252 Family Dollar (FAMILY WELLNESS) 1 BOTTLE, PLASTIC in 1 BOX (55319-252-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC September 15, 2023
55319-252-25 55319-252 Family Dollar (FAMILY WELLNESS) 1 BOTTLE, PLASTIC in 1 BOX (55319-252-25) / 250 TABLET, COATED in 1 BOTTLE, PLASTIC September 15, 2023
55319-252-50 55319-252 Family Dollar (FAMILY WELLNESS) 1 BOTTLE, PLASTIC in 1 BOX (55319-252-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC September 15, 2023
54162-941-00 54162-941 Geritrex LLC 100 TABLET, COATED in 1 BOTTLE, PLASTIC (54162-941-00) October 15, 2018
54162-941-90 54162-941 Geritrex LLC 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (54162-941-90) October 15, 2018
85828-110-22 85828-110 Grocery Outlet, Inc. 200 TABLET, COATED in 1 BOTTLE, PLASTIC (85828-110-22) February 18, 2026
85828-601-53 85828-601 Grocery Outlet, Inc. 500 TABLET, COATED in 1 BOTTLE (85828-601-53) March 10, 2026
37808-109-03 37808-109 HEB 1 BOTTLE, PLASTIC in 1 CARTON (37808-109-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC December 1, 2010
37808-109-08 37808-109 HEB 250 TABLET, COATED in 1 BOTTLE, PLASTIC (37808-109-08) March 1, 2013
37808-109-10 37808-109 HEB 2 BOTTLE, PLASTIC in 1 CARTON (37808-109-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC December 1, 2010
37808-410-02 37808-410 HEB 1 BOTTLE, PLASTIC in 1 CARTON (37808-410-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC January 1, 2013
37808-410-05 37808-410 HEB 500 TABLET, COATED in 1 BOTTLE, PLASTIC (37808-410-05) January 1, 2011
42507-112-03 42507-112 HYVEE INC 1 BOTTLE, PLASTIC in 1 CARTON (42507-112-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC January 13, 2026
42507-112-08 42507-112 HYVEE INC 225 TABLET, COATED in 1 BOTTLE, PLASTIC (42507-112-08) January 13, 2026
42507-865-03 42507-865 HYVEE INC 1 BOTTLE, PLASTIC in 1 CARTON (42507-865-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC January 13, 2026
42507-909-22 42507-909 HYVEE INC 200 TABLET, COATED in 1 BOTTLE, PLASTIC (42507-909-22) January 13, 2026
10158-066-01 10158-066 Haleon US Holdings LLC 592000 TABLET, COATED in 1 DRUM (10158-066-01) May 18, 1984
72036-109-01 72036-109 Harris Teeter 1 BOTTLE, PLASTIC in 1 CARTON (72036-109-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC July 23, 2012
72036-109-02 72036-109 Harris Teeter 1 BOTTLE, PLASTIC in 1 CARTON (72036-109-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC July 23, 2012
72036-109-03 72036-109 Harris Teeter 1 BOTTLE, PLASTIC in 1 CARTON (72036-109-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC July 23, 2012
72036-109-05 72036-109 Harris Teeter 500 TABLET, COATED in 1 BOTTLE, PLASTIC (72036-109-05) August 9, 2012
72036-109-08 72036-109 Harris Teeter 300 TABLET, COATED in 1 BOTTLE, PLASTIC (72036-109-08) August 22, 2012
72036-110-01 72036-110 Harris Teeter 1 BOTTLE, PLASTIC in 1 CARTON (72036-110-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC March 18, 2013
72036-110-02 72036-110 Harris Teeter 1 BOTTLE, PLASTIC in 1 CARTON (72036-110-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC July 23, 2012
72036-110-03 72036-110 Harris Teeter 1 BOTTLE, PLASTIC in 1 CARTON (72036-110-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC July 23, 2012
72036-110-05 72036-110 Harris Teeter 500 TABLET, COATED in 1 BOTTLE, PLASTIC (72036-110-05) August 9, 2012
72036-211-02 72036-211 Harris Teeter 1 BOTTLE, PLASTIC in 1 CARTON (72036-211-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC December 13, 2019
72036-211-03 72036-211 Harris Teeter 1 BOTTLE, PLASTIC in 1 CARTON (72036-211-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC December 13, 2019
72036-212-02 72036-212 Harris Teeter 1 BOTTLE, PLASTIC in 1 CARTON (72036-212-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC December 13, 2019
72036-212-03 72036-212 Harris Teeter 1 BOTTLE, PLASTIC in 1 CARTON (72036-212-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC December 13, 2019
41226-600-01 41226-600 Kroger Company 1 BOTTLE in 1 CARTON (41226-600-01) / 100 TABLET, COATED in 1 BOTTLE June 12, 2021
41226-600-42 41226-600 Kroger Company 1 BOTTLE in 1 CARTON (41226-600-42) / 24 TABLET, COATED in 1 BOTTLE June 12, 2021
41226-600-50 41226-600 Kroger Company 500 TABLET, COATED in 1 BOTTLE (41226-600-50) June 12, 2021
41226-601-01 41226-601 Kroger Company 1 BOTTLE in 1 CARTON (41226-601-01) / 100 TABLET, COATED in 1 BOTTLE June 12, 2021
41226-601-05 41226-601 Kroger Company 1 BOTTLE in 1 CARTON (41226-601-05) / 50 TABLET, COATED in 1 BOTTLE June 12, 2021
41226-601-10 41226-601 Kroger Company 2 BOTTLE in 1 PACKAGE, COMBINATION (41226-601-10) / 500 TABLET, COATED in 1 BOTTLE (41226-601-53) April 15, 2024
41226-601-20 41226-601 Kroger Company 200 TABLET, COATED in 1 BOTTLE (41226-601-20) June 12, 2021
41226-601-25 41226-601 Kroger Company 250 TABLET, COATED in 1 BOTTLE (41226-601-25) June 12, 2021
41226-601-42 41226-601 Kroger Company 1 BOTTLE in 1 CARTON (41226-601-42) / 24 TABLET, COATED in 1 BOTTLE April 10, 2021
41226-601-53 41226-601 Kroger Company 500 TABLET, COATED in 1 BOTTLE (41226-601-53) April 15, 2024
0113-4001-00 0113-4001 L. Perrigo Company 1 BAG in 1 DRUM (0113-4001-00) / 250000 TABLET, COATED in 1 BAG June 15, 1988
0113-4006-00 0113-4006 L. Perrigo Company 1 BAG in 1 DRUM (0113-4006-00) / 244640 TABLET, COATED in 1 BAG February 17, 2006
0113-4552-00 0113-4552 L. Perrigo Company 1 BAG in 1 DRUM (0113-4552-00) / 246000 TABLET, COATED in 1 BAG October 19, 2016
71141-114-32 71141-114 Lidl US LLC 1 BOTTLE, PLASTIC in 1 CARTON (71141-114-32) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC March 31, 2017
68998-012-03 68998-012 MARC GLASSMAN, INC. 1 PACKAGE in 1 CARTON (68998-012-03) / 100 TABLET, COATED in 1 PACKAGE March 1, 2020
68998-011-03 68998-011 Marc Glassman, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (68998-011-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC May 1, 2020
68998-109-03 68998-109 Marc Glassman, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (68998-109-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC June 1, 2009
68998-109-05 68998-109 Marc Glassman, Inc. 500 TABLET, COATED in 1 BOTTLE, PLASTIC (68998-109-05) June 1, 2009
68998-109-08 68998-109 Marc Glassman, Inc. 250 TABLET, COATED in 1 BOTTLE, PLASTIC (68998-109-08) August 1, 2012
68998-109-10 68998-109 Marc Glassman, Inc. 2 BOTTLE, PLASTIC in 1 CARTON (68998-109-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC September 1, 2015
68998-110-03 68998-110 Marc Glassman, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (68998-110-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC June 1, 2009
59726-003-50 59726-003 P & L Development, LLC 500 TABLET, COATED in 1 BOTTLE, PLASTIC (59726-003-50) August 15, 2026
59726-139-50 59726-139 P & L Development, LLC 500 TABLET, COATED in 1 BOTTLE, PLASTIC (59726-139-50) August 15, 2024
63548-0234-1 63548-0234 PLD Acquisitions LLC DBA Avma Pharma Solutions 10 TABLET, COATED in 1 VIAL (63548-0234-1) August 1, 2013
63548-0234-2 63548-0234 PLD Acquisitions LLC DBA Avma Pharma Solutions 1 BOTTLE in 1 BOX (63548-0234-2) / 100 TABLET, COATED in 1 BOTTLE August 1, 2013
63548-0234-3 63548-0234 PLD Acquisitions LLC DBA Avma Pharma Solutions 1000 TABLET, COATED in 1 BOTTLE (63548-0234-3) August 1, 2013
72476-109-01 72476-109 RETAIL BUSINESS SERVICES , LLC. 1 BOTTLE, PLASTIC in 1 CARTON (72476-109-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC February 1, 2020
72476-109-02 72476-109 RETAIL BUSINESS SERVICES , LLC. 1 BOTTLE, PLASTIC in 1 CARTON (72476-109-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC February 1, 2020
72476-109-03 72476-109 RETAIL BUSINESS SERVICES , LLC. 1 BOTTLE, PLASTIC in 1 CARTON (72476-109-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC February 1, 2020
72476-109-05 72476-109 RETAIL BUSINESS SERVICES , LLC. 500 TABLET, COATED in 1 BOTTLE, PLASTIC (72476-109-05) February 1, 2020
72476-109-06 72476-109 RETAIL BUSINESS SERVICES , LLC. 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (72476-109-06) February 1, 2020
72476-109-08 72476-109 RETAIL BUSINESS SERVICES , LLC. 250 TABLET, COATED in 1 BOTTLE, PLASTIC (72476-109-08) February 1, 2020
72476-109-21 72476-109 RETAIL BUSINESS SERVICES , LLC. 1 BOTTLE, PLASTIC in 1 CARTON (72476-109-21) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC February 1, 2020
72476-110-02 72476-110 RETAIL BUSINESS SERVICES , LLC. 1 BOTTLE, PLASTIC in 1 CARTON (72476-110-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC November 1, 2020
72476-110-03 72476-110 RETAIL BUSINESS SERVICES , LLC. 1 PACKAGE in 1 CARTON (72476-110-03) / 100 TABLET, COATED in 1 PACKAGE February 1, 2020
72476-110-04 72476-110 RETAIL BUSINESS SERVICES , LLC. 1 BOTTLE, PLASTIC in 1 CARTON (72476-110-04) / 250 TABLET, COATED in 1 BOTTLE, PLASTIC February 1, 2020
72476-110-05 72476-110 RETAIL BUSINESS SERVICES , LLC. 500 TABLET, COATED in 1 BOTTLE, PLASTIC (72476-110-05) February 1, 2020
72476-111-02 72476-111 RETAIL BUSINESS SERVICES , LLC. 1 BOTTLE, PLASTIC in 1 CARTON (72476-111-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC February 1, 2020
72476-112-02 72476-112 RETAIL BUSINESS SERVICES , LLC. 1 BOTTLE, PLASTIC in 1 CARTON (72476-112-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC February 1, 2020
72476-112-03 72476-112 RETAIL BUSINESS SERVICES , LLC. 1 BOTTLE, PLASTIC in 1 CARTON (72476-112-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC February 1, 2020
11822-7893-2 11822-7893 RITE AID 50 TABLET, COATED in 1 BOTTLE (11822-7893-2) June 1, 2020
11822-7893-5 11822-7893 RITE AID 100 TABLET, COATED in 1 BOTTLE (11822-7893-5) June 1, 2020
11822-8925-5 11822-8925 RITE AID 100 TABLET, COATED in 1 BOTTLE (11822-8925-5) June 1, 2020
11822-8925-9 11822-8925 RITE AID 500 TABLET, COATED in 1 BOTTLE (11822-8925-9) June 1, 2020
11822-7891-2 11822-7891 RITE AID CORPORATION 50 TABLET, COATED in 1 BOTTLE (11822-7891-2) June 1, 2020
11822-7891-5 11822-7891 RITE AID CORPORATION 100 TABLET, COATED in 1 BOTTLE (11822-7891-5) June 1, 2020
11822-7891-9 11822-7891 RITE AID CORPORATION 500 TABLET, COATED in 1 BOTTLE (11822-7891-9) June 1, 2020
11822-7892-0 11822-7892 RITE AID CORPORATION 24 TABLET, COATED in 1 BOTTLE (11822-7892-0) June 1, 2020
11822-7892-2 11822-7892 RITE AID CORPORATION 50 TABLET, COATED in 1 BOTTLE (11822-7892-2) June 1, 2020
11822-7892-5 11822-7892 RITE AID CORPORATION 100 TABLET, COATED in 1 BOTTLE (11822-7892-5) June 1, 2020
11822-7892-7 11822-7892 RITE AID CORPORATION 200 TABLET, COATED in 1 BOTTLE (11822-7892-7) June 1, 2020
11822-7892-9 11822-7892 RITE AID CORPORATION 500 TABLET, COATED in 1 BOTTLE (11822-7892-9) June 1, 2020
68196-601-60 68196-601 SAM'S WEST INC 600 TABLET, COATED in 1 BOTTLE (68196-601-60) June 15, 2024
58624-6001-0 58624-6001 Shandong Xinhua Pharmaceutical Co., Ltd. 34000 TABLET, COATED in 1 CARTON (58624-6001-0) October 5, 2020
58624-6002-0 58624-6002 Shandong Xinhua Pharmaceutical Co., Ltd. 22600 TABLET, COATED in 1 CARTON (58624-6002-0) October 5, 2020
58624-6003-0 58624-6003 Shandong Xinhua Pharmaceutical Co., Ltd. 17000 TABLET, COATED in 1 CARTON (58624-6003-0) October 5, 2020
58624-6004-1 58624-6004 Shandong Xinhua Pharmaceutical Co., Ltd. 45000 TABLET, COATED in 1 CARTON (58624-6004-1) February 28, 2025
83059-0020-4 83059-0020 Shield Pharmaceuticals Corp 1 BOTTLE in 1 CARTON (83059-0020-4) / 40 TABLET, COATED in 1 BOTTLE January 26, 2024
83059-0049-3 83059-0049 Shield Pharmaceuticals Corp 1 BOTTLE in 1 CARTON (83059-0049-3) / 30 TABLET, COATED in 1 BOTTLE October 8, 2024
83059-0082-4 83059-0082 Shield Pharmaceuticals Corp 1 BOTTLE in 1 CARTON (83059-0082-4) / 40 TABLET, COATED in 1 BOTTLE March 16, 2025
83059-0165-3 83059-0165 Shield Pharmaceuticals Corp 1 BOTTLE in 1 CARTON (83059-0165-3) / 30 TABLET, COATED in 1 BOTTLE July 24, 2026
83059-0180-4 83059-0180 Shield Pharmaceuticals Corp 1 BOTTLE in 1 CARTON (83059-0180-4) / 40 TABLET, COATED in 1 BOTTLE September 1, 2026
59556-855-42 59556-855 Strides Pharma Inc 10000 TABLET, COATED in 1 BAG (59556-855-42) March 18, 2022
59556-856-42 59556-856 Strides Pharma Inc 10000 TABLET, COATED in 1 BAG (59556-856-42) March 18, 2022
59556-857-42 59556-857 Strides Pharma Inc 10000 TABLET, COATED in 1 BAG (59556-857-42) March 18, 2022
59556-857-43 59556-857 Strides Pharma Inc 30000 TABLET, COATED in 1 BAG (59556-857-43) June 1, 2023
59556-858-42 59556-858 Strides Pharma Inc 10000 TABLET, COATED in 1 BAG (59556-858-42) March 18, 2022
59556-858-43 59556-858 Strides Pharma Inc 30000 TABLET, COATED in 1 BAG (59556-858-43) June 1, 2023
11673-991-01 11673-991 TARGET CORPORATION 100 TABLET, COATED in 1 BOTTLE (11673-991-01) February 4, 2020
11673-991-05 11673-991 TARGET CORPORATION 50 TABLET, COATED in 1 BOTTLE (11673-991-05) February 4, 2020
11673-991-20 11673-991 TARGET CORPORATION 200 TABLET, COATED in 1 BOTTLE (11673-991-20) February 4, 2020
11673-991-50 11673-991 TARGET CORPORATION 500 TABLET, COATED in 1 BOTTLE (11673-991-50) February 4, 2020
11673-991-88 11673-991 TARGET CORPORATION 1000 TABLET, COATED in 1 BOTTLE (11673-991-88) February 4, 2020
11673-993-01 11673-993 TARGET CORPORATION 100 TABLET, COATED in 1 BOTTLE (11673-993-01) January 1, 2020
11673-993-26 11673-993 TARGET CORPORATION 225 TABLET, COATED in 1 BOTTLE (11673-993-26) January 1, 2020
36800-286-03 36800-286 TOPCO ASSOCIATES LLC 1 BOTTLE, PLASTIC in 1 CARTON (36800-286-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC November 1, 2021
41163-116-03 41163-116 United Natural Foods, Inc. dba UNFI 1 BOTTLE, PLASTIC in 1 CARTON (41163-116-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC May 1, 2020
41163-312-02 41163-312 United Natural Foods, Inc. dba UNFI 1 BOTTLE, PLASTIC in 1 CARTON (41163-312-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC January 1, 2020
41163-312-03 41163-312 United Natural Foods, Inc. dba UNFI 1 BOTTLE, PLASTIC in 1 CARTON (41163-312-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC January 1, 2020
41163-312-05 41163-312 United Natural Foods, Inc. dba UNFI 500 TABLET, COATED in 1 BOTTLE, PLASTIC (41163-312-05) January 1, 2020
41163-509-06 41163-509 United Natural Foods, Inc. dba UNFI 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (41163-509-06) December 31, 2018
41163-509-17 41163-509 United Natural Foods, Inc. dba UNFI 150 TABLET, COATED in 1 BOTTLE, PLASTIC (41163-509-17) December 31, 2018
63941-109-01 63941-109 VALU MERCHANDISERS COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (63941-109-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC May 1, 2017
63941-109-02 63941-109 VALU MERCHANDISERS COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (63941-109-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC May 1, 2017
63941-109-03 63941-109 VALU MERCHANDISERS COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (63941-109-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC May 1, 2017
63941-109-08 63941-109 VALU MERCHANDISERS COMPANY 250 TABLET, COATED in 1 BOTTLE, PLASTIC (63941-109-08) October 30, 2023
63941-109-10 63941-109 VALU MERCHANDISERS COMPANY 2 BOTTLE, PLASTIC in 1 CARTON (63941-109-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC May 1, 2017
63941-111-02 63941-111 VALU MERCHANDISERS COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (63941-111-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC April 1, 2020
63941-209-05 63941-209 VALU MERCHANDISERS COMPANY 500 TABLET, COATED in 1 BOTTLE, PLASTIC (63941-209-05) October 29, 2023
63941-210-01 63941-210 VALU MERCHANDISERS COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (63941-210-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC June 1, 2017
63941-210-02 63941-210 VALU MERCHANDISERS COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (63941-210-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC June 1, 2017
63941-210-03 63941-210 VALU MERCHANDISERS COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (63941-210-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC June 1, 2017
63941-210-10 63941-210 VALU MERCHANDISERS COMPANY 2 BOTTLE, PLASTIC in 1 CARTON (63941-210-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC June 1, 2017
63941-301-02 63941-301 VALU MERCHANDISERS COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (63941-301-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC June 1, 2020
67091-347-05 67091-347 Winco Foods, LLC 500 TABLET, COATED in 1 BOTTLE, PLASTIC (67091-347-05) June 1, 2017
67091-347-10 67091-347 Winco Foods, LLC 1 BOTTLE, PLASTIC in 1 CARTON (67091-347-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC June 1, 2017
67091-347-50 67091-347 Winco Foods, LLC 1 BOTTLE, PLASTIC in 1 CARTON (67091-347-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC June 1, 2017
67091-348-10 67091-348 Winco Foods, LLC 1 BOTTLE, PLASTIC in 1 CARTON (67091-348-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC July 24, 2017
67091-348-50 67091-348 Winco Foods, LLC 1 BOTTLE, PLASTIC in 1 CARTON (67091-348-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC July 24, 2017
57344-109 57344-109 AAA Pharmaceutical, Inc. — October 1, 2012
57344-110 57344-110 AAA Pharmaceutical, Inc. — September 1, 2014
57344-309 57344-309 AAA Pharmaceutical, Inc. — December 5, 2024
57344-811 57344-811 AAA Pharmaceutical, Inc. — February 1, 2020
61504-109 61504-109 AMERIFOODS TRADING COMPANY — October 30, 2023
61504-110 61504-110 AMERIFOODS TRADING COMPANY — October 30, 2023
21130-358 21130-358 BETTER LIVING BRANDS LLC. — July 12, 2019
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63868-268 63868-268 CHAIN DRUG MARKETING ASSOCIATION INC — May 31, 2021
63868-570 63868-570 CHAIN DRUG MARKETING ASSOCIATION INC — March 25, 2020
63868-571 63868-571 CHAIN DRUG MARKETING ASSOCIATION INC — March 25, 2020
83324-100 83324-100 CHAIN DRUG MARKETING ASSOCIATION, INC. — May 15, 2025
83324-101 83324-101 CHAIN DRUG MARKETING ASSOCIATION, INC. — May 8, 2025
83324-102 83324-102 CHAIN DRUG MARKETING ASSOCIATION, INC. — May 15, 2025
69842-489 69842-489 CVS Pharmacy.Inc. — December 18, 2021
53943-111 53943-111 DISCOUNT DRUG MART — March 1, 2020
53943-112 53943-112 DISCOUNT DRUG MART — March 1, 2020
55910-901 55910-901 DOLGENCORP INC — December 9, 2019
53942-112 53942-112 Demoulas Super Markets, Inc — July 16, 2025
55910-768 55910-768 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) — April 30, 2017
75907-428 75907-428 Dr. Reddy's Laboratories Inc. — July 1, 2026
81522-119 81522-119 FSA STORE INC. — January 11, 2023
55319-136 55319-136 Family Dollar (FAMILY WELLNESS) — August 31, 2023
55319-137 55319-137 Family Dollar (FAMILY WELLNESS) — July 30, 2023
55319-252 55319-252 Family Dollar (FAMILY WELLNESS) — September 15, 2023
54162-941 54162-941 Geritrex LLC — October 15, 2018
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85828-601 85828-601 Grocery Outlet, Inc. — March 10, 2026
37808-109 37808-109 HEB — December 1, 2010
37808-410 37808-410 HEB — January 1, 2011
42507-112 42507-112 HYVEE INC — January 13, 2026
42507-865 42507-865 HYVEE INC — January 13, 2026
42507-909 42507-909 HYVEE INC — January 13, 2026
10158-066 10158-066 Haleon US Holdings LLC — May 18, 1984
72036-109 72036-109 Harris Teeter — July 23, 2012
72036-110 72036-110 Harris Teeter — July 23, 2012
72036-211 72036-211 Harris Teeter — December 13, 2019
72036-212 72036-212 Harris Teeter — December 13, 2019
41226-600 41226-600 Kroger Company — June 12, 2021
41226-601 41226-601 Kroger Company — April 10, 2021
0113-4001 0113-4001 L. Perrigo Company — June 15, 1988
0113-4006 0113-4006 L. Perrigo Company — February 17, 2006
0113-4552 0113-4552 L. Perrigo Company — October 19, 2016
71141-114 71141-114 Lidl US LLC — March 31, 2017
68998-012 68998-012 MARC GLASSMAN, INC. — March 1, 2020
68998-011 68998-011 Marc Glassman, Inc. — May 1, 2020
68998-109 68998-109 Marc Glassman, Inc. — June 1, 2009
68998-110 68998-110 Marc Glassman, Inc. — June 1, 2009
59726-003 59726-003 P & L Development, LLC — August 15, 2026
59726-139 59726-139 P & L Development, LLC — August 15, 2024
63548-0185 63548-0185 PLD Acquisitions LLC DBA Avma Pharma Solutions — August 1, 2013
63548-0234 63548-0234 PLD Acquisitions LLC DBA Avma Pharma Solutions — August 1, 2013
72476-109 72476-109 RETAIL BUSINESS SERVICES , LLC. — February 1, 2020
72476-110 72476-110 RETAIL BUSINESS SERVICES , LLC. — February 1, 2020
72476-111 72476-111 RETAIL BUSINESS SERVICES , LLC. — February 1, 2020
72476-112 72476-112 RETAIL BUSINESS SERVICES , LLC. — February 1, 2020
11822-7893 11822-7893 RITE AID — June 1, 2020
11822-8925 11822-8925 RITE AID — June 1, 2020
11822-7891 11822-7891 RITE AID CORPORATION — June 1, 2020
11822-7892 11822-7892 RITE AID CORPORATION — June 1, 2020
68196-601 68196-601 SAM'S WEST INC — June 15, 2024
58624-6001 58624-6001 Shandong Xinhua Pharmaceutical Co., Ltd. — October 5, 2020
58624-6002 58624-6002 Shandong Xinhua Pharmaceutical Co., Ltd. — October 5, 2020
58624-6003 58624-6003 Shandong Xinhua Pharmaceutical Co., Ltd. — October 5, 2020
58624-6004 58624-6004 Shandong Xinhua Pharmaceutical Co., Ltd. — February 28, 2025
83059-0020 83059-0020 Shield Pharmaceuticals Corp — January 26, 2024
83059-0049 83059-0049 Shield Pharmaceuticals Corp — October 8, 2024
83059-0082 83059-0082 Shield Pharmaceuticals Corp — March 16, 2025
83059-0165 83059-0165 Shield Pharmaceuticals Corp — July 24, 2026
83059-0180 83059-0180 Shield Pharmaceuticals Corp — September 1, 2026
83059-0184 83059-0184 Shield Pharmaceuticals Corp — September 21, 2026
59556-855 59556-855 Strides Pharma Inc — March 18, 2022
59556-856 59556-856 Strides Pharma Inc — March 18, 2022
59556-857 59556-857 Strides Pharma Inc — March 18, 2022
59556-858 59556-858 Strides Pharma Inc — March 18, 2022
11673-991 11673-991 TARGET CORPORATION — February 4, 2020
11673-993 11673-993 TARGET CORPORATION — January 1, 2020
36800-286 36800-286 TOPCO ASSOCIATES LLC — November 1, 2021
41163-116 41163-116 United Natural Foods, Inc. dba UNFI — May 1, 2020
41163-312 41163-312 United Natural Foods, Inc. dba UNFI — January 1, 2020
41163-509 41163-509 United Natural Foods, Inc. dba UNFI — December 31, 2018
63941-109 63941-109 VALU MERCHANDISERS COMPANY — May 1, 2017
63941-111 63941-111 VALU MERCHANDISERS COMPANY — April 1, 2020
63941-209 63941-209 VALU MERCHANDISERS COMPANY — October 29, 2023
63941-210 63941-210 VALU MERCHANDISERS COMPANY — June 1, 2017
63941-301 63941-301 VALU MERCHANDISERS COMPANY — June 1, 2020
67091-347 67091-347 Winco Foods, LLC — June 1, 2017
67091-348 67091-348 Winco Foods, LLC — July 24, 2017

Sources for this page

Every dataset that contributed a fact to this page.
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NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

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