Is Naproxen Sodium a prescription drug?

No. Naproxen Sodium is sold over the counter (OTC) without a prescription.

Are there other products with the same active ingredient as Naproxen Sodium?

Yes. Other FDA-listed products with the same active ingredients include All Day Pain Relief, Naproxen, Naproxen Sodium 220mg, Aleve.

Who makes Naproxen Sodium?

59 manufacturers list Naproxen Sodium with the FDA, including Bionpharma Inc., AAA Pharmaceutical, Inc., AAFES/Your Military Exchanges.

Checked Oct 26, 2026

OTC

Naproxen Sodium

Naproxen Sodium is an over-the-counter drug, made by 59 manufacturers.

Type: Over the counter
Drug class: Not classified
Route: Oral
Manufacturers: 59; + 6 repackager labels

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

Drug facts

Name: Naproxen Sodium
Active ingredients: Naproxen Sodium
Dosage forms: Capsule, Capsule, liquid filled, Tablet, Tablet, coated, Tablet, film coated, Tablet, film coated, extended release
Label holder: Bionpharma Inc.
FDA application: NDA021920
Label updated: 08/20/2026

Active ingredients

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

Purpose

Pain reliever/fever reducer

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

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 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- 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 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 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 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 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 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 delivery 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.

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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 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

Ask a doctor or pharmacist before use

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

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

Pregnancy or breastfeeding

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 delivery 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.

Other information

Each capsule contains: sodium 20 mg store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F) protect from light read all directions and warnings before use.

Inactive ingredients

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions?

1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

Forms and strengths

From the FDA NDC Directory · 100 product codes

Dosage form	Strength	Route	NDCs
Capsule	220 mg	oral	1
Capsule, liquid filled	220 mg	oral	32
Tablet	220 mg	oral	11
Tablet, coated	220 mg	oral	22
Tablet, film coated	220 mg	oral	33
Tablet, film coated, extended release	220 mg	oral	1

What pharmacies pay

National Average Drug Acquisition Cost (NADAC), week of 10/21/2026

All prices

Pharmacies paid about $0.0648 to $0.149 per tablet, capsule or unit across 13 package codes.

NADAC is a survey of what retail pharmacies pay to buy a drug. It is not the price you pay at the counter, which depends on your insurance and the pharmacy.

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 142,041 reports that list naproxen sodium, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

Drug ineffective20,260
Pain12,513
Fatigue11,625
Nausea10,786
Arthralgia10,556
Headache9,278
Off label use8,974
Diarrhea8,575
Dizziness8,000
Vomiting7,527

To report a side effect, use FDA MedWatch.

Manufacturers and labels

93 FDA labels · 6 from repackagers

Bionpharma Inc.Shown hereNDA021920 · Label 05/12/2026 · NDC 69452-259Full label
AAA Pharmaceutical, Inc.ANDA079096 · Label 06/17/2025 · NDC 57344-145Full label
AAFES/Your Military ExchangesANDA208363 · Label 05/08/2025 · NDC 55301-748Full label
AMERIFOODS TRADING COMPANYANDA079096 · Label 07/15/2025 · NDC 61504-145Full label
AMERISOURCE BERGENNDA021920 · Label 04/22/2024 · NDC 46122-780Full label
Albertsons CompaniesNDA021920 · Label 09/30/2024 · NDC 21130-948Full label
Amazon.com Services LLCNDA021920 · Label 04/27/2026 · NDC 72288-312Full label
Athlete's Needs IncANDA204872 · Label 11/15/2025 · NDC 53185-604Full label
Aurohealth LLCANDA205497 · Label 05/26/2025 · NDC 58602-738Full label
Aurohealth LLCANDA205497 · Label 05/23/2025 · NDC 58602-819Full label
Aurohealth LLCANDA205497 · Label 05/23/2025 · NDC 58602-845Full label
BETTER LIVING BRANDS LLC.ANDA090545 · Label 06/13/2023 · NDC 21130-690Full label
Better Living Brands, LLCANDA204872 · Label 02/13/2026 · NDC 21130-856Full label
Bionpharma Inc.NDA021920 · Label 12/27/2023 · NDC 69452-179Full label
CHAIN DRUG MARKETING ASSOCIATION INC.NDA021920 · Label 12/21/2022 · NDC 63868-830Full label
CHAIN DRUG MARKETING ASSOCIATION, INC.ANDA079096 · Label 06/20/2025 · NDC 83324-109Full label
CHAIN DRUG MARKETING ASSOCIATION, INC.ANDA079096 · Label 05/20/2025 · NDC 83324-108Full label
CVSANDA091353 · Label 12/19/2025 · NDC 51316-761Full label
CVSANDA091353 · Label 12/19/2025 · NDC 51316-762Full label
CVS PharmacyANDA208363 · Label 05/13/2026 · NDC 69842-748Full label
CVS PharmacyANDA074661 · Label 02/27/2026 · NDC 69842-811Full label
CVS PharmacyANDA074661 · Label 08/22/2023 · NDC 59779-914Full label
Camber Consumer Care IncANDA211065 · Label 11/23/2022 · NDC 69230-329Full label
Care One (American Sales Company)ANDA208363 · Label 11/21/2022 · NDC 41520-748Full label
Care One (Retail Business Services, LLC.)ANDA208363 · Label 02/21/2024 · NDC 72476-748Full label
Chain Drug Marketing AssociationANDA079096 · Label 12/10/2025 · NDC 63868-466Full label
Chain Drug Marketing AssociationANDA079096 · Label 12/10/2025 · NDC 63868-465Full label
DISCOUNT DRUG MART, INC.NDA021920 · Label 03/16/2022 · NDC 53943-179Full label
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDA208363 · Label 11/07/2022 · NDC 55910-748Full label
Dr.Reddy's Laboratories LimitedANDA075168 · Label 06/03/2025 · NDC 55111-272, 55111-273Full label

Repackager labels (6)

A-S Medication Solutions04/27/2023
Bryant Ranch Prepack03/28/2025
PD-Rx Pharmaceuticals, Inc.07/24/2026
PD-Rx Pharmaceuticals, Inc.05/26/2026
Proficient Rx LP05/02/2022
SAM'S WEST INC07/22/2025

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Naproxen Sodium: common questions

What is Naproxen Sodium used for?: 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
Is Naproxen Sodium a prescription drug?: No. Naproxen Sodium is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Naproxen Sodium?: Yes. Other FDA-listed products with the same active ingredients include All Day Pain Relief, Naproxen, Naproxen Sodium 220mg, Aleve.
Who makes Naproxen Sodium?: 59 manufacturers list Naproxen Sodium with the FDA, including Bionpharma Inc., AAA Pharmaceutical, Inc., AAFES/Your Military Exchanges.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 08/20/2026 · Label text is shown as published by the manufacturer. Not medical advice

Same active ingredients

Brands and other versions

Data sources

openFDA drug labels (SPL)U.S. Food and Drug Administration
NDC DirectoryDosage forms, strengths and packages
DailyMedFull labels from the National Library of Medicine

Data as of 08/20/2026

Do not rely on openFDA to make decisions regarding medical care. While FDA makes every effort to ensure that data is accurate, all results should be assumed unvalidated. This page is for information only and is not medical advice. Talk to your doctor or pharmacist before starting, stopping or changing any medicine.

Related health info

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