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Ibuprofen minis

Ibuprofen · Capsule, Liquid Filled

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 minis
Generic name
Ibuprofen
Dosage form
Capsule, Liquid Filled
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Vivunt Pharma LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
16
Packages
46
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

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Liquid Filled
Route of administration
Oral
Presentations
62

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
206568
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 21, 2016
Sponsor
HUMANWELL PURACAP
Products on application
1
Submissions recorded
4
Products approved under application 206568.
Product Trade name Form Strength Ingredient Status TE Flags
206568-001 IBUPROFEN CAPSULE IBUPROFEN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 206568.
Type No. Action Status Date Review
Supplement 24 Labeling Approved September 19, 2023 Standard
Supplement 9 Labeling Approved September 19, 2023 Standard
Supplement 4 Labeling Approved September 19, 2023 Standard
Original application 1 Approved June 21, 2016 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260304). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260304 HUMAN OTC DRUG · 20260105 HUMAN OTC DRUG · 20240820 HUMAN OTC DRUG · 20231016

Indications and Usage

openFDA Drug Labeling

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

Purpose Pain reliever/Fever reducer

Dosage and Administration

openFDA Drug Labeling

Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor Other information each capsule contains: potassium 15 mg read all warnings and directions before use. Keep carton. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F)

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 skin reddening rash blisters If an allergic reaction occurs, stop use and 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 older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if the 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, kidney disease, asthma, or had a stroke 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. Stop use and ask a doctor if 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 If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely 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).

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

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if the 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, kidney disease, asthma, or had a stroke you are taking a diuretic

Stop use and ask a doctor if -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

Drug Facts Active ingredient (in each capsule) Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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
58602-858-12 58602-858 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-858-12) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE September 14, 2023
58602-858-18 58602-858 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-858-18) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE September 14, 2023
58602-858-23 58602-858 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-858-23) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE September 14, 2023
58602-858-30 58602-858 Aurohealth LLC 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-858-30) September 14, 2023
58602-858-34 58602-858 Aurohealth LLC 200 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-858-34) September 14, 2023
58602-858-42 58602-858 Aurohealth LLC 240 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-858-42) September 14, 2023
58602-858-70 58602-858 Aurohealth LLC 1 BOTTLE, PLASTIC in 1 CARTON (58602-858-70) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC September 14, 2023
58602-858-72 58602-858 Aurohealth LLC 1 BOTTLE, PLASTIC in 1 CARTON (58602-858-72) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC September 14, 2023
58602-858-73 58602-858 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-858-73) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE September 14, 2023
58602-858-80 58602-858 Aurohealth LLC 200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (58602-858-80) September 14, 2023
58602-858-96 58602-858 Aurohealth LLC 1 BOTTLE, PLASTIC in 1 CARTON (58602-858-96) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC September 14, 2023
58602-858-98 58602-858 Aurohealth LLC 240 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (58602-858-98) September 14, 2023
69842-643-02 69842-643 CVS Pharmacy 1 BOTTLE, PLASTIC in 1 BOX (69842-643-02) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC December 31, 2018
69842-643-16 69842-643 CVS Pharmacy 1 BOTTLE, PLASTIC in 1 BOX (69842-643-16) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC December 31, 2018
69842-643-20 69842-643 CVS Pharmacy 200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-643-20) December 31, 2018
69842-643-24 69842-643 CVS Pharmacy 1 BOTTLE, PLASTIC in 1 BOX (69842-643-24) / 24 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC December 31, 2018
69842-643-50 69842-643 CVS Pharmacy 500 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-643-50) December 31, 2018
69842-643-80 69842-643 CVS Pharmacy 1 BOTTLE, PLASTIC in 1 BOX (69842-643-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC December 31, 2018
69842-643-88 69842-643 CVS Pharmacy 1 BOTTLE, PLASTIC in 1 BOX (69842-643-88) / 88 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC December 31, 2018
72476-843-16 72476-843 Care One (Retail Business Services, LLC.) 1 BOTTLE, PLASTIC in 1 BOX (72476-843-16) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC June 30, 2020
72476-843-20 72476-843 Care One (Retail Business Services, LLC.) 1 BOTTLE, PLASTIC in 1 BOX (72476-843-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC June 30, 2020
72476-843-40 72476-843 Care One (Retail Business Services, LLC.) 1 BOTTLE, PLASTIC in 1 BOX (72476-843-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC June 30, 2020
72476-843-80 72476-843 Care One (Retail Business Services, LLC.) 1 BOTTLE, PLASTIC in 1 BOX (72476-843-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC June 30, 2020
63981-192-05 63981-192 Costco Wholesale 500 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (63981-192-05) November 1, 2024
55910-953-20 55910-953 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 1 BOTTLE, PLASTIC in 1 BOX (55910-953-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC March 31, 2019
55910-953-80 55910-953 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 1 BOTTLE, PLASTIC in 1 BOX (55910-953-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC March 31, 2019
49035-265-16 49035-265 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49035-265-16) December 31, 2019
49035-265-30 49035-265 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49035-265-30) December 31, 2019
49035-265-80 49035-265 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49035-265-80) December 31, 2019
55319-971-16 55319-971 Family Dollar (FAMILY WELLNESS) 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (55319-971-16) July 1, 2023
55319-971-80 55319-971 Family Dollar (FAMILY WELLNESS) 1 BOTTLE, PLASTIC in 1 BOX (55319-971-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC July 1, 2023
85828-700-80 85828-700 Grocery Outlet, Inc. 1 BOTTLE in 1 CARTON (85828-700-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE March 5, 2026
72036-015-80 72036-015 Harris Teeter 1 BOTTLE in 1 CARTON (72036-015-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE August 16, 2024
59726-843-10 59726-843 P & L Development, LLC 1 BOTTLE, PLASTIC in 1 BOX (59726-843-10) / 10 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC December 31, 2020
21130-843-16 21130-843 Safeway, Inc. 1 BOTTLE, PLASTIC in 1 BOX (21130-843-16) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC December 5, 2018
21130-843-80 21130-843 Safeway, Inc. 1 BOTTLE, PLASTIC in 1 BOX (21130-843-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC December 5, 2018
70677-1113-1 70677-1113 Strategic Sourcing Services LLC 1 BOTTLE, PLASTIC in 1 BOX (70677-1113-1) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC March 31, 2023
30142-743-16 30142-743 The Kroger Co. 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (30142-743-16) September 30, 2019
30142-743-32 30142-743 The Kroger Co. 2 BOTTLE, PLASTIC in 1 BOX (30142-743-32) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC September 30, 2019
30142-743-80 30142-743 The Kroger Co. 1 BOTTLE, PLASTIC in 1 BOX (30142-743-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC September 30, 2019
82706-032-01 82706-032 Vivunt Pharma LLC 1 BOTTLE, PLASTIC in 1 BOX (82706-032-01) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC August 1, 2026
82706-032-02 82706-032 Vivunt Pharma LLC 1 BOTTLE, PLASTIC in 1 BOX (82706-032-02) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC August 1, 2026
69607-8438-0 69607-8438 WR Group, Inc. 1 BOTTLE, PLASTIC in 1 BOX (69607-8438-0) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2025
0363-0743-20 0363-0743 Walgreens 1 BOTTLE, PLASTIC in 1 BOX (0363-0743-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC March 31, 2019
0363-0743-80 0363-0743 Walgreens 1 BOTTLE, PLASTIC in 1 BOX (0363-0743-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC March 31, 2019
0363-0743-96 0363-0743 Walgreens 1 BOTTLE, PLASTIC in 1 BOX (0363-0743-96) / 96 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC March 31, 2019
58602-858 58602-858 Aurohealth LLC — September 14, 2023
69842-643 69842-643 CVS Pharmacy — December 31, 2018
72476-843 72476-843 Care One (Retail Business Services, LLC.) — June 30, 2020
63981-192 63981-192 Costco Wholesale — November 1, 2024
55910-953 55910-953 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) — March 31, 2019
49035-265 49035-265 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) — December 31, 2019
55319-971 55319-971 Family Dollar (FAMILY WELLNESS) — July 1, 2023
85828-700 85828-700 Grocery Outlet, Inc. — March 5, 2026
72036-015 72036-015 Harris Teeter — August 16, 2024
59726-843 59726-843 P & L Development, LLC — December 31, 2020
21130-843 21130-843 Safeway, Inc. — December 5, 2018
70677-1113 70677-1113 Strategic Sourcing Services LLC — March 31, 2023
30142-743 30142-743 The Kroger Co. — September 30, 2019
82706-032 82706-032 Vivunt Pharma LLC — August 1, 2026
69607-8438 69607-8438 WR Group, Inc. — April 1, 2025
0363-0743 0363-0743 Walgreens — March 31, 2019

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
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

Generated September 25, 2026 · 10 sections on this page.