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Naproxen Sodium
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Naproxen Sodium | 220 mg/1 | 849431 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| 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| 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 BookCodes 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 | 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| 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUses 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
Purpose
openFDA Drug LabelingPurposes Pain reliever/fever reducer
Purposes Pain reliever/fever reducer
Dosage and Administration
openFDA Drug LabelingDirections 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
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo 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 LabelingAsk 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
openFDA Drug LabelingStop 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 LabelingActive ingredients (in each capsule) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Adverse event reports
Source: openFDA FAERSAttributed 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| 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
| 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.