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Naproxen Sodium

Over-the-counter NDA RLD 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
Naproxen Sodium
Generic name
Naproxen Sodium
Dosage form
Capsule, Liquid Filled
Route
—
Marketing category
NDA · NDA
Labeler
Bionpharma Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
37
Packages
82
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
Naproxen Sodium 220 mg/1 849431 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Liquid Filled
Route of administration
—
Presentations
119

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
021920
Application type
NDA · New Drug Application
Approval date
February 17, 2006
Sponsor
BIONPHARMA
Products on application
1
Submissions recorded
16
Products approved under application 021920.
Product Trade name Form Strength Ingredient Status TE Flags
021920-001 NAPROXEN SODIUM CAPSULE NAPROXEN SODIUM Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
10028925 March 3, 2026 001 No U-1731 July 24, 2018
10022344 March 3, 2026 001 No U-1731 July 23, 2018
10028925 March 3, 2026 001 No U-1732 July 24, 2018
10022344 March 3, 2026 001 No U-1732 July 23, 2018
11090280 March 3, 2026 001 No U-1731 August 24, 2021
11090280 March 3, 2026 001 No U-1732 August 24, 2021
9693979 March 3, 2026 001 No November 13, 2017
9693978 March 3, 2026 001 No November 13, 2017

Approval history

Source: Drugs@FDA
Most recent submissions on application 021920.
Type No. Action Status Date Review
Supplement 41 Labeling Approved January 15, 2026 Standard
Supplement 36 Labeling Approved December 13, 2021 Standard
Supplement 33 Labeling Approved December 12, 2020 Standard
Supplement 28 Labeling Approved April 30, 2020 Standard
Supplement 27 Labeling Approved February 27, 2020 Standard
Supplement 26 Labeling Approved December 9, 2019 Standard
Supplement 25 Labeling Approved October 26, 2019 Standard
Supplement 23 Labeling Approved February 20, 2019 Standard
Supplement 22 Labeling Approved November 29, 2018 Standard
Supplement 19 Labeling Approved March 16, 2017 Standard
Supplement 18 Labeling Approved April 1, 2013 Standard
Supplement 17 Labeling Approved June 13, 2012 Standard
Supplement 13 Labeling Approved August 12, 2010 Standard
Supplement 11 Labeling Approved July 14, 2009 Standard
Supplement 10 Labeling Approved April 15, 2009 Standard
Original application 1 Type 3 - New Dosage Form Approved February 17, 2006 Standard

Review documents

  • 0 · Supplement · January 27, 2026
  • 0 · Supplement · January 20, 2026
  • 0 · Supplement · December 16, 2021
  • 0 · Supplement · December 16, 2021
  • 0 · Supplement · December 15, 2020
  • 0 · Supplement · May 1, 2020
  • 0 · Supplement · May 1, 2020
  • 0 · Supplement · February 28, 2020
  • 0 · Supplement · February 28, 2020
  • 0 · Supplement · December 11, 2019
  • 0 · Supplement · December 11, 2019
  • 0 · Supplement · October 29, 2019
  • 0 · Supplement · October 29, 2019
  • 0 · Supplement · February 22, 2019
  • 0 · Supplement · February 21, 2019
  • 0 · Supplement · December 20, 2018
  • 0 · Supplement · December 4, 2018
  • 0 · Supplement · March 20, 2017
  • 0 · Supplement · March 17, 2017
  • 0 · Supplement · November 25, 2013
  • 0 · Supplement · April 3, 2013
  • 0 · Supplement · June 15, 2012
  • 0 · Supplement · August 16, 2010
  • 0 · Supplement · July 24, 2009
  • 0 · Supplement · July 17, 2009
  • 0 · Supplement · April 21, 2009
  • 0 · Original application · February 22, 2008
  • 0 · Original application · March 2, 2006
  • 0 · Original application · March 1, 2006
  • 0 · Original application · February 28, 2006

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250508). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250508 HUMAN OTC DRUG · 20240930 HUMAN OTC DRUG · 20240422 HUMAN OTC DRUG · 20221229

Indications and Usage

openFDA Drug Labeling

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

Purposes 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 drink a full glass of water with each dose if taken with food, this product may take longer to work adults and children 12 years and older: take 1 capsule every 8 hours to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8-hour to 12-hour period do not exceed 3 capsules in a 24-hour period children under 12 years: ask a doctor

Warnings Allergy alert: Naproxen sodium 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 have 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) 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 a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease asthma, or had a stroke you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers 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 naproxen 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 stool have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing leg swelling slurred speech weakness in one part or side of body 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 you have difficulty swallowing it feels like the capsule is stuck in your throat If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium 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 (1-800-222-1222) right away.

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 a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease asthma, or had a stroke you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers

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 you have difficulty swallowing it feels like the capsule is stuck in your throat

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each capsule) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Adverse event reports

Source: openFDA FAERS
165,056
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: NAPROXEN SODIUM. 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
55301-748-20 55301-748 AAFES/Your Military Exchanges 1 BOTTLE, PLASTIC in 1 BOX (55301-748-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC February 28, 2018
46122-780-64 46122-780 AMERISOURCE BERGEN 1 BOTTLE in 1 CARTON (46122-780-64) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE April 11, 2024
21130-948-11 21130-948 Albertsons Companies 1 BOTTLE, PLASTIC in 1 CARTON (21130-948-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC September 26, 2023
21130-948-15 21130-948 Albertsons Companies 1 BOTTLE, PLASTIC in 1 CARTON (21130-948-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC September 26, 2023
21130-948-16 21130-948 Albertsons Companies 1 BOTTLE, PLASTIC in 1 CARTON (21130-948-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC October 1, 2024
21130-948-78 21130-948 Albertsons Companies 80 CAPSULE, LIQUID FILLED in 1 BOTTLE (21130-948-78) September 26, 2023
72288-312-25 72288-312 Amazon.com Services LLC 180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (72288-312-25) February 12, 2024
69452-179-22 69452-179 Bionpharma Inc. 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-179-22) November 1, 2018
69452-259-21 69452-259 Bionpharma Inc. 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-259-21) May 12, 2026
69452-259-25 69452-259 Bionpharma Inc. 180 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-259-25) August 2, 2019
69452-259-78 69452-259 Bionpharma Inc. 1 BOTTLE in 1 CARTON (69452-259-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE August 2, 2019
69452-284-25 69452-284 Bionpharma Inc. 180 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-284-25) January 22, 2021
63868-830-20 63868-830 CHAIN DRUG MARKETING ASSOCIATION INC. 1 BOTTLE, PLASTIC in 1 CARTON (63868-830-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC June 3, 2021
69842-748-08 69842-748 CVS Pharmacy 80 CAPSULE, LIQUID FILLED in 1 BOTTLE (69842-748-08) April 1, 2018
69842-748-16 69842-748 CVS Pharmacy 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (69842-748-16) April 1, 2018
69842-748-20 69842-748 CVS Pharmacy 1 BOTTLE, PLASTIC in 1 BOX (69842-748-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
69842-748-30 69842-748 CVS Pharmacy 1 BOTTLE, PLASTIC in 1 BOX (69842-748-30) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
69842-748-40 69842-748 CVS Pharmacy 1 BOTTLE, PLASTIC in 1 BOX (69842-748-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
69842-748-50 69842-748 CVS Pharmacy 1 BOTTLE, PLASTIC in 1 BOX (69842-748-50) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
69842-748-80 69842-748 CVS Pharmacy 1 BOTTLE, PLASTIC in 1 BOX (69842-748-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
41520-748-20 41520-748 Care One (American Sales Company) 1 BOTTLE, PLASTIC in 1 BOX (41520-748-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
41520-748-80 41520-748 Care One (American Sales Company) 1 BOTTLE, PLASTIC in 1 BOX (41520-748-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
72476-748-20 72476-748 Care One (Retail Business Services, LLC.) 1 BOTTLE, PLASTIC in 1 BOX (72476-748-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 30, 2021
72476-748-80 72476-748 Care One (Retail Business Services, LLC.) 1 BOTTLE, PLASTIC in 1 BOX (72476-748-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 30, 2021
53943-179-11 53943-179 DISCOUNT DRUG MART, INC. 1 BOTTLE, PLASTIC in 1 CARTON (53943-179-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC November 1, 2018
55910-748-20 55910-748 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 1 BOTTLE, PLASTIC in 1 BOX (55910-748-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
55910-748-40 55910-748 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 1 BOTTLE, PLASTIC in 1 BOX (55910-748-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
49035-748-12 49035-748 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49035-748-12) April 1, 2018
49035-748-20 49035-748 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 1 BOTTLE, PLASTIC in 1 BOX (49035-748-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
49035-748-80 49035-748 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49035-748-80) April 1, 2018
37808-049-15 37808-049 HEB 1 BOTTLE, PLASTIC in 1 CARTON (37808-049-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC January 1, 2019
37808-049-16 37808-049 HEB 1 BOTTLE, PLASTIC in 1 CARTON (37808-049-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC July 20, 2022
37808-049-78 37808-049 HEB 1 BOTTLE, PLASTIC in 1 CARTON (37808-049-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC January 1, 2019
53345-042-01 53345-042 Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd 1 BAG in 1 BOX (53345-042-01) / 5000 CAPSULE, LIQUID FILLED in 1 BAG March 20, 2018
30142-285-22 30142-285 KROGER COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (30142-285-22) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC October 9, 2019
30142-285-78 30142-285 KROGER COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (30142-285-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC June 4, 2019
41250-225-15 41250-225 MEIJER DISTRIBUTION INC 1 BOTTLE, PLASTIC in 1 CARTON (41250-225-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC February 1, 2019
41250-225-16 41250-225 MEIJER DISTRIBUTION INC 1 BOTTLE, PLASTIC in 1 CARTON (41250-225-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 30, 2021
41250-225-78 41250-225 MEIJER DISTRIBUTION INC 1 BOTTLE, PLASTIC in 1 CARTON (41250-225-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC February 1, 2019
59726-174-20 59726-174 P & L Development, LLC 1 BOTTLE, PLASTIC in 1 BOX (59726-174-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
59726-174-80 59726-174 P & L Development, LLC 1 BOTTLE, PLASTIC in 1 BOX (59726-174-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
10888-5015-0 10888-5015 Patheon Softgels Inc 6000 CAPSULE, LIQUID FILLED in 1 CONTAINER (10888-5015-0) September 30, 2014
10888-8227-1 10888-8227 Patheon Softgels Inc. 6000 CAPSULE, LIQUID FILLED in 1 BOX (10888-8227-1) October 16, 2023
10888-8271-1 10888-8271 Patheon Softgels Inc. 6000 CAPSULE, LIQUID FILLED in 1 BOX (10888-8271-1) June 20, 2023
10888-8270-1 10888-8270 Patheon Softgels, Inc. 6000 CAPSULE, LIQUID FILLED in 1 BOX (10888-8270-1) June 27, 2023
68016-056-40 68016-056 Premier Value Alliance LLC 1 BOTTLE, PLASTIC in 1 CARTON (68016-056-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC October 25, 2018
51013-137-15 51013-137 PuraCap Pharmaceutical LLC 1 BOTTLE in 1 CARTON (51013-137-15) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE March 20, 2018
51013-137-28 51013-137 PuraCap Pharmaceutical LLC 1 BOTTLE in 1 CARTON (51013-137-28) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE March 20, 2018
51013-137-60 51013-137 PuraCap Pharmaceutical LLC 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-137-60) March 20, 2018
11822-0788-4 11822-0788 Rite Aid Corporation 1 BOTTLE, PLASTIC in 1 CARTON (11822-0788-4) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 15, 2020
11822-0788-5 11822-0788 Rite Aid Corporation 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (11822-0788-5) June 18, 2021
11822-0788-6 11822-0788 Rite Aid Corporation 1 BOTTLE, PLASTIC in 1 CARTON (11822-0788-6) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC March 1, 2023
41163-079-15 41163-079 SUPERVALU INC 1 BOTTLE, PLASTIC in 1 CARTON (41163-079-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC January 15, 2019
21130-748-20 21130-748 Safeway, Inc. 1 BOTTLE, PLASTIC in 1 BOX (21130-748-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
21130-748-40 21130-748 Safeway, Inc. 1 BOTTLE, PLASTIC in 1 BOX (21130-748-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
21130-748-80 21130-748 Safeway, Inc. 80 CAPSULE, LIQUID FILLED in 1 BOTTLE (21130-748-80) April 1, 2018
70677-1148-1 70677-1148 Strategic Sourcing Services LLC 1 BOTTLE, PLASTIC in 1 BOX (70677-1148-1) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC March 31, 2023
11673-651-78 11673-651 TARGET Corporation 1 BOTTLE, PLASTIC in 1 CARTON (11673-651-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC December 8, 2025
11673-748-18 11673-748 TARGET Corporation 180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (11673-748-18) April 1, 2018
11673-748-40 11673-748 TARGET Corporation 1 BOTTLE, PLASTIC in 1 BOX (11673-748-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
11673-748-80 11673-748 TARGET Corporation 1 BOTTLE, PLASTIC in 1 BOX (11673-748-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
36800-204-11 36800-204 TOP CARE (Topco Associates LLC) 1 BOTTLE, PLASTIC in 1 CARTON (36800-204-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC July 2, 2021
36800-204-16 36800-204 TOP CARE (Topco Associates LLC) 1 BOTTLE, PLASTIC in 1 CARTON (36800-204-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC July 2, 2021
36800-204-78 36800-204 TOP CARE (Topco Associates LLC) 1 BOTTLE, PLASTIC in 1 CARTON (36800-204-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC July 2, 2021
63941-681-16 63941-681 VALU MERCHANDISERS COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (63941-681-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC October 3, 2023
0363-0102-15 0363-0102 WALGREEN COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (0363-0102-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC March 19, 2020
0363-0177-11 0363-0177 WALGREEN COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (0363-0177-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC August 2, 2019
0363-0177-15 0363-0177 WALGREEN COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (0363-0177-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC August 2, 2019
0363-0177-16 0363-0177 WALGREEN COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (0363-0177-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 30, 2020
0363-0177-22 0363-0177 WALGREEN COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (0363-0177-22) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC August 2, 2019
0363-0177-25 0363-0177 WALGREEN COMPANY 180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-0177-25) August 2, 2019
0363-0177-78 0363-0177 WALGREEN COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (0363-0177-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC August 2, 2019
0363-0177-99 0363-0177 WALGREEN COMPANY 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-0177-99) August 2, 2019
49035-382-22 49035-382 Wal-Mart Stores, Inc. 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (49035-382-22) March 1, 2020
49035-382-78 49035-382 Wal-Mart Stores, Inc. 80 CAPSULE, LIQUID FILLED in 1 BOTTLE (49035-382-78) March 1, 2020
0363-0748-08 0363-0748 Walgreens 1 BOTTLE, PLASTIC in 1 BOX (0363-0748-08) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
0363-0748-12 0363-0748 Walgreens 1 BOTTLE, PLASTIC in 1 BOX (0363-0748-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
0363-0748-18 0363-0748 Walgreens 180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-0748-18) April 1, 2018
0363-0748-20 0363-0748 Walgreens 1 BOTTLE, PLASTIC in 1 BOX (0363-0748-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
0363-0748-40 0363-0748 Walgreens 1 BOTTLE, PLASTIC in 1 BOX (0363-0748-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
0363-0748-50 0363-0748 Walgreens 1 BOTTLE, PLASTIC in 1 BOX (0363-0748-50) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC April 1, 2018
0363-0748-80 0363-0748 Walgreens 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-0748-80) April 1, 2018
55301-748 55301-748 AAFES/Your Military Exchanges — February 28, 2018
46122-780 46122-780 AMERISOURCE BERGEN — April 11, 2024
21130-948 21130-948 Albertsons Companies — September 26, 2023
72288-312 72288-312 Amazon.com Services LLC — February 12, 2024
69452-179 69452-179 Bionpharma Inc. — November 1, 2018
69452-259 69452-259 Bionpharma Inc. — August 2, 2019
69452-284 69452-284 Bionpharma Inc. — January 22, 2021
63868-830 63868-830 CHAIN DRUG MARKETING ASSOCIATION INC. — June 3, 2021
69842-748 69842-748 CVS Pharmacy — April 1, 2018
41520-748 41520-748 Care One (American Sales Company) — April 1, 2018
72476-748 72476-748 Care One (Retail Business Services, LLC.) — April 30, 2021
53943-179 53943-179 DISCOUNT DRUG MART, INC. — November 1, 2018
55910-748 55910-748 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) — April 1, 2018
49035-748 49035-748 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) — April 1, 2018
37808-049 37808-049 HEB — January 1, 2019
53345-042 53345-042 Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd — March 20, 2018
30142-285 30142-285 KROGER COMPANY — February 1, 2019
41250-225 41250-225 MEIJER DISTRIBUTION INC — February 1, 2019
59726-174 59726-174 P & L Development, LLC — April 1, 2018
10888-5015 10888-5015 Patheon Softgels Inc — September 30, 2014
10888-8227 10888-8227 Patheon Softgels Inc. — October 16, 2023
10888-8271 10888-8271 Patheon Softgels Inc. — June 20, 2023
10888-8270 10888-8270 Patheon Softgels, Inc. — June 27, 2023
68016-056 68016-056 Premier Value Alliance LLC — October 25, 2018
51013-137 51013-137 PuraCap Pharmaceutical LLC — March 20, 2018
11822-0788 11822-0788 Rite Aid Corporation — April 15, 2020
41163-079 41163-079 SUPERVALU INC — January 15, 2019
21130-748 21130-748 Safeway, Inc. — April 1, 2018
70677-1148 70677-1148 Strategic Sourcing Services LLC — March 31, 2023
11673-651 11673-651 TARGET Corporation — December 8, 2025
11673-748 11673-748 TARGET Corporation — April 1, 2018
36800-204 36800-204 TOP CARE (Topco Associates LLC) — July 2, 2021
63941-681 63941-681 VALU MERCHANDISERS COMPANY — October 3, 2023
0363-0102 0363-0102 WALGREEN COMPANY — August 2, 2019
0363-0177 0363-0177 WALGREEN COMPANY — August 2, 2019
49035-382 49035-382 Wal-Mart Stores, Inc. — March 1, 2020
0363-0748 0363-0748 Walgreens — April 1, 2018

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
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 13 sections on this page.