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Bayer Aleve

Naproxen Sodium · Tablet

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
Bayer Aleve
Generic name
Naproxen Sodium
Dosage form
Tablet
Route
Oral
Marketing category
NDA · NDA
Labeler
Acme United Corporation
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
3
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
5

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
020204
Application type
NDA · New Drug Application
Approval date
January 11, 1994
Sponsor
BAYER
Products on application
1
Submissions recorded
64
Products approved under application 020204.
Product Trade name Form Strength Ingredient Status TE Flags
020204-002 ALEVE TABLET 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.

Approval history

Source: Drugs@FDA
Most recent submissions on application 020204.
Type No. Action Status Date Review
Supplement 90 Labeling Approved March 10, 2026 Standard
Supplement 89 Labeling Approved April 24, 2025 Standard
Supplement 88 Labeling Approved September 11, 2024 Standard
Supplement 84 Manufacturing (CMC) Approved April 4, 2023 N/A
Supplement 83 Labeling Approved March 10, 2022 Standard
Supplement 81 Labeling Approved April 1, 2021 Standard
Supplement 80 Labeling Approved December 31, 2020 Standard
Supplement 79 Labeling Approved December 31, 2020 Standard
Supplement 78 Labeling Approved December 31, 2020 Standard
Supplement 77 Labeling Approved December 31, 2020 Standard
Supplement 76 Labeling Approved October 28, 2020 Standard
Supplement 72 Labeling Approved May 8, 2020 Standard
Supplement 71 Labeling Approved April 23, 2020 Standard
Supplement 70 Labeling Approved March 2, 2020 Standard
Supplement 68 Labeling Approved August 7, 2019 Standard
Supplement 67 Labeling Approved July 23, 2019 Standard
Supplement 66 Labeling Approved July 2, 2019 Standard
Supplement 65 Labeling Approved May 13, 2019 Standard
Supplement 64 Labeling Approved May 13, 2019 Standard
Supplement 63 Labeling Approved May 13, 2019 Standard
Supplement 61 Labeling Approved January 28, 2019 Standard
Supplement 62 Labeling Approved January 3, 2019 Standard
Supplement 59 Labeling Approved September 21, 2018 Standard
Supplement 58 Labeling Approved August 28, 2018 Standard
Supplement 57 Labeling Approved July 25, 2018 Standard
Supplement 56 Labeling Approved June 11, 2018 Standard
Supplement 55 Labeling Approved June 8, 2018 Standard
Supplement 54 Labeling Approved March 29, 2018 Standard
Supplement 53 Labeling Approved March 27, 2018 Standard
Supplement 52 Labeling Approved September 14, 2017 Standard
Supplement 51 Labeling Approved August 22, 2017 Standard
Supplement 49 Manufacturing (CMC) Approved July 28, 2016 Standard
Supplement 48 Manufacturing (CMC) Approved February 25, 2016 Standard
Supplement 46 Manufacturing (CMC) Approved February 4, 2015 Standard
Supplement 44 Labeling Approved April 18, 2013 Standard
Supplement 38 Labeling Approved February 7, 2013 Standard
Supplement 43 Manufacturing (CMC) Approved January 7, 2013 Standard
Supplement 42 Manufacturing (CMC) Approved January 3, 2013 Standard
Supplement 41 Manufacturing (CMC) Approved November 13, 2012 Standard
Supplement 40 Labeling Approved March 16, 2012 Standard
Supplement 39 Labeling Approved March 15, 2012 Standard
Supplement 37 Labeling Approved April 8, 2011 Standard
Supplement 36 Labeling Approved February 18, 2011 Standard
Supplement 35 Labeling Approved November 3, 2010 Standard
Supplement 32 Labeling Approved April 15, 2009 Standard
Supplement 31 Labeling Approved November 24, 2008 Standard
Supplement 23 Labeling Approved January 6, 2006 Standard
Supplement 21 Labeling Approved May 4, 2005 Standard
Supplement 19 Labeling Approved March 22, 2004 Standard
Supplement 16 Manufacturing (CMC) Approved August 30, 2002 Standard
Supplement 8 Labeling Approved March 19, 2002 Standard
Supplement 15 Manufacturing (CMC) Approved December 21, 2001 Standard
Supplement 14 Manufacturing (CMC) Approved March 27, 2001 Standard
Supplement 7 Labeling Approved March 6, 2001 Standard
Supplement 13 Manufacturing (CMC) Approved January 3, 2001 Standard
Supplement 10 Labeling Approved August 23, 2000 Standard
Supplement 12 Manufacturing (CMC) Approved June 7, 2000 Standard
Supplement 11 Manufacturing (CMC) Approved May 11, 2000 Standard
Supplement 6 Manufacturing (CMC) Approved November 20, 1998 Standard
Supplement 5 Manufacturing (CMC) Approved April 16, 1998 Standard

Review documents

  • 0 · Supplement · March 12, 2026
  • 0 · Supplement · March 12, 2026
  • 0 · Supplement · May 1, 2025
  • 0 · Supplement · May 1, 2025
  • 0 · Supplement · September 16, 2024
  • 0 · Supplement · September 16, 2024
  • 0 · Supplement · June 13, 2023
  • 0 · Supplement · June 13, 2023
  • 0 · Supplement · March 15, 2022
  • 0 · Supplement · March 11, 2022
  • 0 · Supplement · April 23, 2021
  • 0 · Supplement · April 19, 2021
  • 0 · Supplement · April 19, 2021
  • 0 · Supplement · April 19, 2021
  • 0 · Supplement · April 19, 2021
  • 0 · Supplement · April 5, 2021
  • 0 · Supplement · February 23, 2021
  • 0 · Supplement · January 4, 2021
  • 0 · Supplement · January 4, 2021
  • 0 · Supplement · January 4, 2021
  • 0 · Supplement · January 4, 2021
  • 0 · Supplement · November 2, 2020
  • 0 · Supplement · August 17, 2020
  • 0 · Supplement · August 3, 2020
  • 0 · Supplement · May 11, 2020
  • 0 · Supplement · April 24, 2020
  • 0 · Supplement · March 4, 2020
  • 0 · Supplement · March 4, 2020
  • 0 · Supplement · August 13, 2019
  • 0 · Supplement · August 12, 2019

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20230320). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20230320

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

Purpose

openFDA Drug Labeling

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 Adults and children: (12 years and older) take 1 caplet every 8 to 12 hours while symptoms last for the first dose you may take 2 caplets within the first hour do not exceed 2 caplets in any 8 to 12- hour period do not exceedc3 caplets in a 24- hour period. Children under 12 years: ask a doctor

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,s except aspirin, increase the risk of heart attack, heart failure and stroke. These can be fatal. This 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 ever have 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, 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 Labeling

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 for more than 10 days fever gets worse or lasts for 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 caplet) 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
0924-6000-00 0924-6000 Acme United Corporation 1 TABLET in 1 POUCH (0924-6000-00) March 24, 2023
0924-6000-01 0924-6000 Acme United Corporation 50 POUCH in 1 BOX (0924-6000-01) / 1 TABLET in 1 POUCH March 24, 2023
47682-488-50 47682-488 Unifirst First Aid Corporation 50 POUCH in 1 BOX (47682-488-50) / 1 TABLET in 1 POUCH January 24, 2014
0924-6000 0924-6000 Acme United Corporation — March 24, 2023
47682-488 47682-488 Unifirst First Aid Corporation — January 24, 2014

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 · 11 sections on this page.