FDA.reportPublic FDA data

Bayer Aleve

Product NDC
47682-488
11-digit product format
476820488
Labeler code
47682
Product ID
47682-488_3e5d43d6-74c5-08f6-e063-6394a90a0a54
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
NDA020204
Marketing category
NDA
Marketing start
2014-01-24
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bayer Aleve
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574, 849728

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
47682-488-50Bayer Aleve1 in 1 POUCHTABLET111
47682-488-50Bayer Aleve50 in 1 BOXTABLET5011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CBAYER ALEVE (NAPROXEN SODIUM) TABLET [UNIFIRST FIRST AID CORPORATION]1
NAPROXENACTIVE MOIETY57Y76R9ATQBAYER ALEVE (NAPROXEN SODIUM) TABLET [UNIFIRST FIRST AID CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBAYER ALEVE (NAPROXEN SODIUM) TABLET [UNIFIRST FIRST AID CORPORATION]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBAYER ALEVE (NAPROXEN SODIUM) TABLET [UNIFIRST FIRST AID CORPORATION]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBAYER ALEVE (NAPROXEN SODIUM) TABLET [UNIFIRST FIRST AID CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BAYER ALEVE (NAPROXEN SODIUM) TABLET [UNIFIRST FIRST AID CORPORATION]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABAYER ALEVE (NAPROXEN SODIUM) TABLET [UNIFIRST FIRST AID CORPORATION]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EBAYER ALEVE (NAPROXEN SODIUM) TABLET [UNIFIRST FIRST AID CORPORATION]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBAYER ALEVE (NAPROXEN SODIUM) TABLET [UNIFIRST FIRST AID CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBAYER ALEVE (NAPROXEN SODIUM) TABLET [UNIFIRST FIRST AID CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-488BAYER ALEVE (NAPROXEN SODIUM) TABLET [UNIFIRST FIRST AID CORPORATION]10Current NDC, Legacy NDC, 2 package rows20240829_5dd569ca-d03e-410c-af98-4732c823d595.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849728Aleve 220 MG Oral TabletPSN5dd569ca-d03e-410c-af98-4732c823d59511
849574naproxen sodium 220 MG Oral TabletPSN5dd569ca-d03e-410c-af98-4732c823d59511
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBD5dd569ca-d03e-410c-af98-4732c823d59511
849574naproxen sodium 220 MG Oral TabletSCD5dd569ca-d03e-410c-af98-4732c823d59511
849728Aleve 220 MG Oral TabletSY5dd569ca-d03e-410c-af98-4732c823d59511
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY5dd569ca-d03e-410c-af98-4732c823d59511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-488-504768204885050 POUCH in 1 BOX (47682-488-50) / 1 TABLET in 1 POUCH50 pouch2014-01-240000-00-00NoNoCurrent