FDA.reportPublic FDA data

Aleve

Product NDC
0280-6020
11-digit product format
002806020
Labeler code
0280
Product ID
0280-6020_4526be49-a72d-1db7-e063-6394a90a1937
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0280-6020-02AleveGelcaps1 in 1 CARTONTABLET, COATED116
0280-6020-02AleveGelcaps90 in 1 BOTTLETABLET, COATED9016
0280-6020-16AleveGelcaps160 in 1 BOTTLETABLET, COATED16016
0280-6020-20AleveGelcaps20 in 1 BOTTLETABLET, COATED2016
0280-6020-20AleveGelcaps1 in 1 CARTONTABLET, COATED116
0280-6020-40AleveGelcaps40 in 1 BOTTLETABLET, COATED4016
0280-6020-40AleveGelcaps1 in 1 CARTONTABLET, COATED116
0280-6020-80AleveGelcaps80 in 1 BOTTLETABLET, COATED8016
0280-6020-80AleveGelcaps1 in 1 CARTONTABLET, COATED116

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
0280-6020ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE LLC.]15Current NDC, Legacy NDC, 9 package rows20241208_0ad8bbb9-dd5f-4273-b085-ee3e5ed22613.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849728Aleve 220 MG Oral TabletPSN0ad8bbb9-dd5f-4273-b085-ee3e5ed2261316
849574naproxen sodium 220 MG Oral TabletPSN0ad8bbb9-dd5f-4273-b085-ee3e5ed2261316
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBD0ad8bbb9-dd5f-4273-b085-ee3e5ed2261316
849574naproxen sodium 220 MG Oral TabletSCD0ad8bbb9-dd5f-4273-b085-ee3e5ed2261316
849728Aleve 220 MG Oral TabletSY0ad8bbb9-dd5f-4273-b085-ee3e5ed2261316
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY0ad8bbb9-dd5f-4273-b085-ee3e5ed2261316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-6020-02002806020021 BOTTLE in 1 CARTON (0280-6020-02) / 90 TABLET, COATED in 1 BOTTLE1 bottle2022-10-200000-00-00NoNoCurrent
0280-6020-1600280602016160 TABLET, COATED in 1 BOTTLE (0280-6020-16) 2019-09-260000-00-00NoNoCurrent
0280-6020-200028060202020 in 1 BOTTLEHistorical
0280-6020-400028060204040 in 1 BOTTLEHistorical
0280-6020-800028060208080 in 1 BOTTLEHistorical