FDA.reportPublic FDA data

Aleve

Product NDC
66715-6402
11-digit product format
667156402
Labeler code
66715
Product ID
66715-6402_2b10873f-6944-0eaf-e063-6294a90a7041
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Lil' Drug Store Products, Inc
Application
NDA020204
Marketing category
NDA
Marketing start
2022-04-19
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
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
66715-6402-8Aleve1 in 1 POUCHTABLET110
66715-6402-8Aleve30 in 1 BOX, UNIT-DOSETABLET3010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Naproxen SodiumACTIVE INGREDIENT9TN87S3A3CALEVE (NAPROXEN SODIUM) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
NaproxenACTIVE MOIETY57Y76R9ATQALEVE (NAPROXEN SODIUM) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933ALEVE (NAPROXEN SODIUM) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UALEVE (NAPROXEN SODIUM) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
FD&C blue no. 2INACTIVE INGREDIENTL06K8R7DQKALEVE (NAPROXEN SODIUM) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOALEVE (NAPROXEN SODIUM) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30ALEVE (NAPROXEN SODIUM) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AALEVE (NAPROXEN SODIUM) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
PovidonesINACTIVE INGREDIENTFZ989GH94EALEVE (NAPROXEN SODIUM) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
TalcINACTIVE INGREDIENT7SEV7J4R1UALEVE (NAPROXEN SODIUM) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPALEVE (NAPROXEN SODIUM) TABLET [LIL' DRUG STORE PRODUCTS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6402ALEVE (NAPROXEN SODIUM) TABLET ALEVE, TRAVEL BASIX (NAPROXEN SODIUM) TABLET [LIL' DRUG STORE PRODUCTS, INC]10Current NDC, 2 package rows20250109_abfcf13e-6eba-49e2-8ebf-459348714270.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849728Aleve 220 MG Oral TabletPSNabfcf13e-6eba-49e2-8ebf-45934871427010
849574naproxen sodium 220 MG Oral TabletPSNabfcf13e-6eba-49e2-8ebf-45934871427010
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBDabfcf13e-6eba-49e2-8ebf-45934871427010
849574naproxen sodium 220 MG Oral TabletSCDabfcf13e-6eba-49e2-8ebf-45934871427010
849728Aleve 220 MG Oral TabletSYabfcf13e-6eba-49e2-8ebf-45934871427010
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYabfcf13e-6eba-49e2-8ebf-45934871427010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66715-6402-86671564020830 POUCH in 1 BOX, UNIT-DOSE (66715-6402-8) / 1 TABLET in 1 POUCH30 pouch2022-04-19NoNoHistorical