FDA.reportPublic FDA data

Aleve

Product NDC
0280-6070
11-digit product format
002806070
Labeler code
0280
Product ID
0280-6070_4526b744-fa19-0f7b-e063-6394a90a916e
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA020204
Marketing category
NDA
Marketing start
2002-08-01
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
Brand name suffix
Gelcaps
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
0280-6070-40AleveGelcaps40 in 1 BOTTLETABLET, COATED4014
0280-6070-40AleveGelcaps1 in 1 CARTONTABLET, COATED114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-6070-40EA - Each0280-607076bcd6bc-e38b-4d68-8427-3444e080ed6e12022-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1
NAPROXENACTIVE MOIETY57Y76R9ATQALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1
GELATININACTIVE INGREDIENT2G86QN327LALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1
TALCINACTIVE INGREDIENT7SEV7J4R1UALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-6070ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE LLC.]13Current NDC, Legacy NDC, 2 package rows20231201_acea54a2-5a92-428e-a778-bb4f9d676782.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849728Aleve 220 MG Oral TabletPSNacea54a2-5a92-428e-a778-bb4f9d67678214
849574naproxen sodium 220 MG Oral TabletPSNacea54a2-5a92-428e-a778-bb4f9d67678214
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBDacea54a2-5a92-428e-a778-bb4f9d67678214
849574naproxen sodium 220 MG Oral TabletSCDacea54a2-5a92-428e-a778-bb4f9d67678214
849728Aleve 220 MG Oral TabletSYacea54a2-5a92-428e-a778-bb4f9d67678214
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYacea54a2-5a92-428e-a778-bb4f9d67678214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-6070-40002806070401 BOTTLE in 1 CARTON (0280-6070-40) / 40 TABLET, COATED in 1 BOTTLE1 bottle2002-08-010000-00-00NoNoCurrent