On this page

Aleve

Naproxen Sodium · Capsule, Liquid Filled

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
Aleve
Generic name
Naproxen Sodium
Dosage form
Capsule, Liquid Filled
Route
Oral
Marketing category
NDA · NDA
Labeler
Bayer HealthCare LLC.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
8
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
Capsule, Liquid Filled
Route of administration
Oral
Presentations
10

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
021920
Application type
NDA · New Drug Application
Approval date
February 17, 2006
Sponsor
BIONPHARMA
Products on application
1
Submissions recorded
16
Products approved under application 021920.
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 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.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
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
Most recent submissions on application 021920.
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 Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251204). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251204 HUMAN OTC DRUG · 20251204

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

Purposes Pain reliever/fever reducer

Dosage and Administration

openFDA Drug Labeling

Directions do not take more than directed the smallest effective doses hould 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

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. 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. 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, 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 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 If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of 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 right away.

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 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 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 capsule) 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
0280-6080-01 0280-6080 Bayer HealthCare LLC. 1 BOTTLE in 1 CARTON (0280-6080-01) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE February 20, 2007
0280-6080-02 0280-6080 Bayer HealthCare LLC. 2 BOTTLE in 1 PACKAGE, COMBINATION (0280-6080-02) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE February 20, 2007
0280-6080-04 0280-6080 Bayer HealthCare LLC. 1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-04) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC October 20, 2022
0280-6080-16 0280-6080 Bayer HealthCare LLC. 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-6080-16) February 20, 2007
0280-6080-20 0280-6080 Bayer HealthCare LLC. 1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC February 20, 2007
0280-6080-40 0280-6080 Bayer HealthCare LLC. 1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC February 20, 2007
0280-6080-80 0280-6080 Bayer HealthCare LLC. 1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC February 20, 2007
0280-6091-80 0280-6091 Bayer HealthCare LLC. 1 BOTTLE, PLASTIC in 1 CARTON (0280-6091-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC July 28, 2007
0280-6080 0280-6080 Bayer HealthCare LLC. — February 20, 2007
0280-6091 0280-6091 Bayer HealthCare LLC. — February 28, 2007

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
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.