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Aleve
Naproxen Sodium · Capsule, Liquid Filled
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 |
|---|---|---|---|---|---|---|---|
| 021920-001 | NAPROXEN SODIUM | CAPSULE | NAPROXEN SODIUM | Over-the-counter | — | RLD RS |
Therapeutic equivalence
Source: Orange BookCodes 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 | 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| 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 LabelingReproduced 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.
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 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
Warnings
openFDA Drug LabelingStomach 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
openFDA Drug LabelingDo 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 LabelingAsk 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 capsule) Naproxen sodium 220 mg (naproxen 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 |
|---|---|---|---|---|
| 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
| 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.