Naproxen Sodium (NSAID) — Tablet

Overview

Brand name

Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever

Generic name

Naproxen Sodium

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Amneal Pharmaceuticals of New York LLC

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

6

Data completeness

76% 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

Tablet

Route of administration

Oral

Presentations

8

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@FDA NDC Directory

Application number

079096

Application type

ANDA · Abbreviated New Drug Application

Approval date

December 16, 2008

Sponsor

AMNEAL PHARMS NY

Products on application

1

Submissions recorded

5

Products approved under application 079096.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
079096-001	NAPROXEN SODIUM	TABLET		NAPROXEN SODIUM	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 079096.
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 Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20231231). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20231231

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

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 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 Other information each tablet contains: sodium 20 mg store at 20 to 25°C (68 to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Warnings

openFDA Drug Labeling

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: NSAID, 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

openFDA Drug Labeling

DO NOT USE if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery

Stop Use

openFDA Drug Labeling

STOP USE 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

Active Ingredient

openFDA Drug Labeling

ACTIVE INGREDIENT (in each tablet) Naproxen sodium USP, 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
53746-191-05	53746-191	Amneal Pharmaceuticals of New York LLC	500 TABLET in 1 BOTTLE (53746-191-05)	November 25, 2009
53746-191-08	53746-191	Amneal Pharmaceuticals of New York LLC	8 TABLET in 1 VIAL (53746-191-08)	November 25, 2009
53746-191-24	53746-191	Amneal Pharmaceuticals of New York LLC	24 TABLET in 1 BOTTLE (53746-191-24)	November 25, 2009
53746-192-05	53746-192	Amneal Pharmaceuticals of New York LLC	500 TABLET in 1 BOTTLE (53746-192-05)	November 25, 2009
53746-192-08	53746-192	Amneal Pharmaceuticals of New York LLC	8 TABLET in 1 VIAL (53746-192-08)	November 25, 2009
53746-192-24	53746-192	Amneal Pharmaceuticals of New York LLC	24 TABLET in 1 BOTTLE (53746-192-24)	November 25, 2009
53746-191	53746-191	Amneal Pharmaceuticals of New York LLC	—	November 25, 2009
53746-192	53746-192	Amneal Pharmaceuticals of New York LLC	—	November 25, 2009

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.