FDA.reportPublic FDA data

Naproxen Sodium

Manufacturer
Athlete's Needs Inc | LNK International, Inc.
Effective date
2025-11-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:16:21

Label at a glance#

ProductNaproxen Sodium
Active ingredientNAPROXEN SODIUM
Label structure9 sections

Indications and uses

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

Dosage and administration

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 exceed 3 caplets in a 24-hour period children under 12 years: ask a doctor

Storage and handling

each caplet contains: sodium 20 mg store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F) use by expiration date on package

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • asthma (wheezing)
  • skin reddening
  • shock
  • blisters
  • rash
  • facial swelling
  • hives

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]
  • take more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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 have problems or serious side effects from taking pain relievers or fever reducers
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - WHEN USING SECTION

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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:
    • leg swelling
    • chest pain
    • slurred speech
    • trouble breathing
    • weakness in one part or side of body
  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 exceed 3 caplets in a 24-hour period
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: sodium 20 mg
  • store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clear Choice

NAPROXEN
SODIUM

Pain Reliever
Fever Reducer
(NSAID)*

PAIN & FEVER RELIEF
STRENGTH TO LAST 12 HOURS

Compare to Active
Ingredient in Aleve®**

50 Caplets 220 mg Each

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

**This product is not manufactured or distributed by Bayer HealthCare
LLC, owner of the registered trademark Aleve®.

Distributed by: A.N.I. Toledo, OH 43623

50844
REV1221B60415

Clear Choice 44-604
Clear Choice 44-604

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
849574naproxen sodium 220 MG Oral TabletPSN6
849574naproxen sodium 220 MG Oral TabletSCD6
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NAPROXEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130092617374506GTIN-13: 0092617374506
EAN-13: 0092617374506
GTIN-12: 092617374506
UPC-A: 092617374506
GTIN storage (14 digits): 00092617374506		clear-choice-44-604-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53185-604-12Naproxen Sodium100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1006
53185-604-15Naproxen Sodium50 in 1 BOTTLE, PLASTICTABLET, FILM COATED506

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53185-60453185-604-15, 53185-604-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
NAPROXEN SODIUM9TN87S3A3CACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C BLUE NO. 2 ALUMINUM LAKE4AQJ3LG584IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204872-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2017-01-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23c2088c7a36db…
2026-09-14 22:38:342026-08A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2384e616aacf4f…
2026-08-18 06:07:402026-07A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-233f01610625f2…
2019-09-15 20:21 UTC2019-09A204872-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2017-01-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A204872-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2017-01-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-233a93d1ddd44b…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen SodiumNAPROXEN SODIUMAthlete's Needs Incd5984c9d-3941-45d6-8392-87564b2faae02025-11-15WarningsExact identifier
ndc (package): 53185-604-12
ndc (package): 53185-604-15
ndc (product): 53185-604
ndc11 (package): 53185060412
ndc11 (package): 53185060415
spl id: b5125434-5aab-4cbd-afba-c6ca1381b2a9
spl set id: d5984c9d-3941-45d6-8392-87564b2faae0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.