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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 |
|---|---|---|---|---|---|---|---|
| 079096-001 | NAPROXEN SODIUM | TABLET | NAPROXEN SODIUM | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 8 | Labeling | Approved | February 24, 2015 | Standard |
| Supplement | 2 | Manufacturing (CMC) | Approved | February 24, 2015 | — |
| Supplement | 9 | Labeling | Approved | August 11, 2014 | Standard |
| Supplement | 4 | Labeling | Approved | January 31, 2011 | — |
| Original application | 1 | Approved | December 16, 2008 | — |
Review documents
- 0 · Original application · January 6, 2009
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250722). 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
Dosage and Administration
openFDA Drug LabelingDirections 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 ) drink a full glass of water with each dose adults and children 12 years and older take 1 tablet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8- to 12-hour period do not exceed 3 tablets in a 24-hour period children under 12 years ask a doctor
Warnings
openFDA Drug LabelingWarnings SPL UNCLASSIFIED SECTION 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. SPL UNCLASSIFIED SECTION Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or olderhave had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAID's (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 SPL UNCLASSIFIED SECTION Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, hear failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. OTC- ASK A DOCTOR SECTION 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, 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 OTC- DO NOT USE SECTION Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery OTC - ASK DOCTOR/PHARMACIST SECTION Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug OTC - WHEN USING SECTION When using this product take with food or milk if stomach upset occurs OTC - PREGNANCY OR BREAST FEEDING SECTION 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. OTC - STOP USE SECTION 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 you have difficulty swallowing it feels like the pill is stuck in your throat redness or swelling is present in the painful area any new symptoms appear OTC - KEEP OUT OF REACH OF CHILDREN SECTION 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
openFDA Drug LabelingOTC- DO NOT USE SECTION 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 LabelingOTC- ASK A DOCTOR SECTION 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, 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 ■ you have difficulty swallowing ■ it feels like the pill is stuck in your throat ■ redness or swelling is present in the painful area ■ any new symptoms appear
Active Ingredient
openFDA Drug LabelingActive ingredient (in each tablet/caplet) Naproxen sodium USP, 220 mg (naproxen USP, 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 |
|---|---|---|---|---|
| 57344-145-01 | 57344-145 | AAA Pharmaceutical, Inc. | 1 BOTTLE, PLASTIC in 1 CARTON (57344-145-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC | April 1, 2012 |
| 61504-145-02 | 61504-145 | AMERIFOODS TRADING COMPANY | 1 BOTTLE, PLASTIC in 1 CARTON (61504-145-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC | October 30, 2023 |
| 83324-108-01 | 83324-108 | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1 BOTTLE, PLASTIC in 1 CARTON (83324-108-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | May 20, 2025 |
| 83324-108-24 | 83324-108 | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1 BOTTLE, PLASTIC in 1 CARTON (83324-108-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC | May 20, 2025 |
| 83324-108-50 | 83324-108 | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1 BOTTLE, PLASTIC in 1 CARTON (83324-108-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC | May 20, 2025 |
| 83324-109-01 | 83324-109 | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1 BOTTLE, PLASTIC in 1 PACKAGE (83324-109-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | May 20, 2025 |
| 83324-109-50 | 83324-109 | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1 BOTTLE, PLASTIC in 1 CARTON (83324-109-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC | May 20, 2025 |
| 63868-465-01 | 63868-465 | Chain Drug Marketing Association | 1 BOTTLE, PLASTIC in 1 CARTON (63868-465-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | September 3, 2009 |
| 63868-465-50 | 63868-465 | Chain Drug Marketing Association | 1 BOTTLE, PLASTIC in 1 CARTON (63868-465-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC | September 3, 2009 |
| 63868-466-01 | 63868-466 | Chain Drug Marketing Association | 1 BOTTLE, PLASTIC in 1 CARTON (63868-466-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | June 19, 2009 |
| 63868-466-25 | 63868-466 | Chain Drug Marketing Association | 1 BOTTLE, PLASTIC in 1 CARTON (63868-466-25) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC | May 2, 2013 |
| 63868-466-50 | 63868-466 | Chain Drug Marketing Association | 1 BOTTLE, PLASTIC in 1 CARTON (63868-466-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC | June 19, 2009 |
| 43598-058-29 | 43598-058 | Dr Reddy's Laboratories Inc | 200 TABLET, COATED in 1 BOTTLE (43598-058-29) | August 4, 2021 |
| 55111-273-95 | 55111-273 | Dr. Reddy's Laboratories Limited | 5000 TABLET, COATED in 1 POUCH (55111-273-95) | July 29, 1998 |
| 43598-059-52 | 43598-059 | Dr.Reddy's Laboratories Inc | 225 TABLET, COATED in 1 BOTTLE (43598-059-52) | August 5, 2021 |
| 43598-060-52 | 43598-060 | Dr.Reddy's Laboratories Inc | 225 TABLET, COATED in 1 BOTTLE (43598-060-52) | August 5, 2021 |
| 43598-071-01 | 43598-071 | Dr.Reddy's Laboratories Inc | 1 BOTTLE in 1 CARTON (43598-071-01) / 100 TABLET, COATED in 1 BOTTLE | December 10, 2021 |
| 43598-072-01 | 43598-072 | Dr.Reddy's Laboratories Inc | 1 BOTTLE in 1 CARTON (43598-072-01) / 100 TABLET, COATED in 1 BOTTLE | December 10, 2021 |
| 43598-073-01 | 43598-073 | Dr.Reddy's Laboratories Inc | 1 BOTTLE in 1 CARTON (43598-073-01) / 100 TABLET, COATED in 1 BOTTLE | December 10, 2021 |
| 43598-074-01 | 43598-074 | Dr.Reddy's Laboratories Inc | 1 BOTTLE in 1 CARTON (43598-074-01) / 100 TABLET, COATED in 1 BOTTLE | December 10, 2021 |
| 55111-272-01 | 55111-272 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-272-01) / 100 TABLET, COATED in 1 BOTTLE | July 29, 1998 |
| 55111-272-02 | 55111-272 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-272-02) / 200 TABLET, COATED in 1 BOTTLE | July 29, 1998 |
| 55111-272-05 | 55111-272 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-272-05) / 500 TABLET, COATED in 1 BOTTLE | July 29, 1998 |
| 55111-272-24 | 55111-272 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-272-24) / 24 TABLET, COATED in 1 BOTTLE | July 29, 1998 |
| 55111-272-50 | 55111-272 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-272-50) / 50 TABLET, COATED in 1 BOTTLE | July 29, 1998 |
| 55111-273-01 | 55111-273 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-273-01) / 100 TABLET, COATED in 1 BOTTLE | July 29, 1998 |
| 55111-273-02 | 55111-273 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-273-02) / 200 TABLET, COATED in 1 BOTTLE | July 29, 1998 |
| 55111-273-05 | 55111-273 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-273-05) / 500 TABLET, COATED in 1 BOTTLE | July 29, 1998 |
| 55111-273-24 | 55111-273 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-273-24) / 24 TABLET, COATED in 1 BOTTLE | July 29, 1998 |
| 55111-273-40 | 55111-273 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-273-40) / 400 TABLET, COATED in 1 BOTTLE | July 29, 1998 |
| 55111-273-50 | 55111-273 | Dr.Reddy's Laboratories Limited | 1 BOTTLE in 1 CARTON (55111-273-50) / 50 TABLET, COATED in 1 BOTTLE | July 29, 1998 |
| 81522-045-05 | 81522-045 | FSA STORE INC. | 1 BOTTLE, PLASTIC in 1 CARTON (81522-045-05) / 200 TABLET, COATED in 1 BOTTLE, PLASTIC | May 2, 2023 |
| 42507-245-01 | 42507-245 | HYVEE INC | 1 BOTTLE, PLASTIC in 1 CARTON (42507-245-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC | January 13, 2026 |
| 42507-245-14 | 42507-245 | HYVEE INC | 1 BOTTLE, PLASTIC in 1 CARTON (42507-245-14) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC | January 13, 2026 |
| 42507-844-01 | 42507-844 | HYVEE INC | 1 BOTTLE, PLASTIC in 1 CARTON (42507-844-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC | January 13, 2026 |
| 42507-844-14 | 42507-844 | HYVEE INC | 1 BOTTLE, PLASTIC in 1 CARTON (42507-844-14) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC | January 13, 2026 |
| 72036-144-01 | 72036-144 | Harris Teeter | 1 BOTTLE, PLASTIC in 1 CARTON (72036-144-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC | July 17, 2012 |
| 72036-144-02 | 72036-144 | Harris Teeter | 1 BOTTLE, PLASTIC in 1 CARTON (72036-144-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC | December 1, 2011 |
| 72036-144-03 | 72036-144 | Harris Teeter | 1 BOTTLE, PLASTIC in 1 CARTON (72036-144-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | December 1, 2011 |
| 72036-145-01 | 72036-145 | Harris Teeter | 1 BOTTLE, PLASTIC in 1 CARTON (72036-145-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC | July 17, 2012 |
| 72036-145-02 | 72036-145 | Harris Teeter | 1 BOTTLE, PLASTIC in 1 CARTON (72036-145-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC | December 1, 2011 |
| 72036-145-03 | 72036-145 | Harris Teeter | 1 BOTTLE, PLASTIC in 1 CARTON (72036-145-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | December 1, 2011 |
| 72036-145-08 | 72036-145 | Harris Teeter | 200 TABLET, COATED in 1 BOTTLE, PLASTIC (72036-145-08) | October 28, 2014 |
| 30142-954-10 | 30142-954 | Kroger Company | 1 BOTTLE in 1 CARTON (30142-954-10) / 100 TABLET, COATED in 1 BOTTLE | August 4, 2021 |
| 30142-954-20 | 30142-954 | Kroger Company | 1 BOTTLE in 1 CARTON (30142-954-20) / 200 TABLET, COATED in 1 BOTTLE | August 4, 2021 |
| 30142-954-50 | 30142-954 | Kroger Company | 1 BOTTLE in 1 CARTON (30142-954-50) / 500 TABLET, COATED in 1 BOTTLE | August 4, 2021 |
| 41226-609-05 | 41226-609 | Kroger Company | 1 BOTTLE in 1 CARTON (41226-609-05) / 50 TABLET, COATED in 1 BOTTLE | June 12, 2021 |
| 68998-144-03 | 68998-144 | Marc Glassman, Inc. | 1 BOTTLE, PLASTIC in 1 CARTON (68998-144-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | June 1, 2009 |
| 68998-145-03 | 68998-145 | Marc Glassman, Inc. | 1 BOTTLE, PLASTIC in 1 CARTON (68998-145-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | May 31, 2009 |
| 10888-8127-1 | 10888-8127 | Patheon Softgels Inc. | 1000000 TABLET, COATED in 1 CASE (10888-8127-1) | June 22, 2010 |
| 68196-255-20 | 68196-255 | SAM'S WEST INC | 400 TABLET, COATED in 1 BOTTLE (68196-255-20) | March 1, 2023 |
| 68196-255-40 | 68196-255 | SAM'S WEST INC | 400 TABLET, COATED in 1 BOTTLE (68196-255-40) | May 1, 2025 |
| 63941-444-01 | 63941-444 | VALU MERCHANDISERS COMPANY | 1 BOTTLE, PLASTIC in 1 CARTON (63941-444-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC | May 1, 2024 |
| 63941-444-02 | 63941-444 | VALU MERCHANDISERS COMPANY | 1 BOTTLE, PLASTIC in 1 CARTON (63941-444-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC | May 1, 2024 |
| 63941-444-03 | 63941-444 | VALU MERCHANDISERS COMPANY | 1 BOTTLE, PLASTIC in 1 CARTON (63941-444-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | May 1, 2024 |
| 63941-445-01 | 63941-445 | VALU MERCHANDISERS COMPANY | 1 BOTTLE, PLASTIC in 1 CARTON (63941-445-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC | May 1, 2024 |
| 63941-445-02 | 63941-445 | VALU MERCHANDISERS COMPANY | 1 BOTTLE, PLASTIC in 1 CARTON (63941-445-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC | May 1, 2024 |
| 63941-445-03 | 63941-445 | VALU MERCHANDISERS COMPANY | 1 BOTTLE, PLASTIC in 1 CARTON (63941-445-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | May 1, 2024 |
| 67091-138-50 | 67091-138 | WinCo Foods, LLC | 1 BOTTLE, PLASTIC in 1 CARTON (67091-138-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC | December 15, 2014 |
| 67091-140-10 | 67091-140 | WinCo Foods, LLC | 1 BOTTLE, PLASTIC in 1 CARTON (67091-140-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | December 15, 2014 |
| 67091-140-50 | 67091-140 | WinCo Foods, LLC | 1 BOTTLE, PLASTIC in 1 CARTON (67091-140-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC | December 15, 2014 |
| 57344-145 | 57344-145 | AAA Pharmaceutical, Inc. | — | April 1, 2012 |
| 61504-145 | 61504-145 | AMERIFOODS TRADING COMPANY | — | October 30, 2023 |
| 83324-108 | 83324-108 | CHAIN DRUG MARKETING ASSOCIATION, INC. | — | May 20, 2025 |
| 83324-109 | 83324-109 | CHAIN DRUG MARKETING ASSOCIATION, INC. | — | May 20, 2025 |
| 63868-465 | 63868-465 | Chain Drug Marketing Association | — | September 3, 2009 |
| 63868-466 | 63868-466 | Chain Drug Marketing Association | — | June 19, 2009 |
| 43598-058 | 43598-058 | Dr Reddy's Laboratories Inc | — | August 4, 2021 |
| 43598-059 | 43598-059 | Dr.Reddy's Laboratories Inc | — | August 5, 2021 |
| 43598-060 | 43598-060 | Dr.Reddy's Laboratories Inc | — | August 5, 2021 |
| 43598-071 | 43598-071 | Dr.Reddy's Laboratories Inc | — | December 10, 2021 |
| 43598-072 | 43598-072 | Dr.Reddy's Laboratories Inc | — | December 10, 2021 |
| 43598-073 | 43598-073 | Dr.Reddy's Laboratories Inc | — | December 10, 2021 |
| 43598-074 | 43598-074 | Dr.Reddy's Laboratories Inc | — | December 10, 2021 |
| 55111-272 | 55111-272 | Dr.Reddy's Laboratories Limited | — | July 29, 1998 |
| 55111-273 | 55111-273 | Dr.Reddy's Laboratories Limited | — | July 29, 1998 |
| 81522-045 | 81522-045 | FSA STORE INC. | — | May 2, 2023 |
| 42507-245 | 42507-245 | HYVEE INC | — | January 13, 2026 |
| 42507-844 | 42507-844 | HYVEE INC | — | January 13, 2026 |
| 72036-144 | 72036-144 | Harris Teeter | — | December 1, 2011 |
| 72036-145 | 72036-145 | Harris Teeter | — | December 1, 2011 |
| 30142-954 | 30142-954 | Kroger Company | — | August 4, 2021 |
| 41226-609 | 41226-609 | Kroger Company | — | June 12, 2021 |
| 68998-144 | 68998-144 | Marc Glassman, Inc. | — | June 1, 2009 |
| 68998-145 | 68998-145 | Marc Glassman, Inc. | — | May 31, 2009 |
| 10888-8127 | 10888-8127 | Patheon Softgels Inc. | — | June 22, 2010 |
| 68196-255 | 68196-255 | SAM'S WEST INC | — | July 29, 1998 |
| 63941-444 | 63941-444 | VALU MERCHANDISERS COMPANY | — | May 1, 2024 |
| 63941-445 | 63941-445 | VALU MERCHANDISERS COMPANY | — | May 1, 2024 |
| 67091-138 | 67091-138 | WinCo Foods, LLC | — | December 15, 2014 |
| 67091-140 | 67091-140 | WinCo Foods, LLC | — | December 15, 2014 |
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 |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.