FDA.reportPublic FDA data

Aleve

Product NDC
0280-6050
11-digit product format
002806050
Labeler code
0280
Product ID
0280-6050_3271583e-5034-ed79-e063-6294a90a0b0e
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA020204
Marketing category
NDA
Marketing start
2013-11-11
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
Caplets - Easy Open Arthritis Cap
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
0280-6050-01AleveCaplets - Easy Open Arthritis Cap100 in 1 BOTTLETABLET10019
0280-6050-02AleveCaplets - Easy Open Arthritis Cap24 in 1 BOTTLETABLET2419
0280-6050-03AleveCaplets - Easy Open Arthritis Cap130 in 1 BOTTLETABLET13019
0280-6050-03AleveCaplets - Easy Open Arthritis Cap1 in 1 CARTONTABLET119
0280-6050-04AleveCaplets - Easy Open Arthritis Cap1 in 1 CARTONTABLET119
0280-6050-04AleveCaplets - Easy Open Arthritis Cap150 in 1 BOTTLETABLET15019
0280-6050-05AleveCaplets - Easy Open Arthritis Cap110 in 1 BOTTLETABLET11019
0280-6050-06AleveCaplets - Easy Open Arthritis Cap90 in 1 BOTTLETABLET9019
0280-6050-27AleveCaplets - Easy Open Arthritis Cap270 in 1 BOTTLETABLET27019
0280-6050-27AleveCaplets - Easy Open Arthritis Cap1 in 1 CARTONTABLET119
0280-6050-50AleveCaplets - Easy Open Arthritis Cap50 in 1 BOTTLETABLET5019
0280-6050-50AleveCaplets - Easy Open Arthritis Cap1 in 1 CARTONTABLET119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-6050-01EA - Each0280-60502ffc0b90-ac14-42a9-b2cb-223e71589d4712022-02-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CALEVE CAPLETS - EASY OPEN ARTHRITIS CAP (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE CONSUMER CARE]1
NAPROXENACTIVE MOIETY57Y76R9ATQALEVE CAPLETS - EASY OPEN ARTHRITIS CAP (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE CONSUMER CARE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALEVE CAPLETS - EASY OPEN ARTHRITIS CAP (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE CONSUMER CARE]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALEVE CAPLETS - EASY OPEN ARTHRITIS CAP (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE CONSUMER CARE]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALEVE CAPLETS - EASY OPEN ARTHRITIS CAP (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE CONSUMER CARE]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALEVE CAPLETS - EASY OPEN ARTHRITIS CAP (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE CONSUMER CARE]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALEVE CAPLETS - EASY OPEN ARTHRITIS CAP (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE CONSUMER CARE]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EALEVE CAPLETS - EASY OPEN ARTHRITIS CAP (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE CONSUMER CARE]1
TALCINACTIVE INGREDIENT7SEV7J4R1UALEVE CAPLETS - EASY OPEN ARTHRITIS CAP (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE CONSUMER CARE]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALEVE CAPLETS - EASY OPEN ARTHRITIS CAP (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE CONSUMER CARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-6050ALEVE CAPLETS - EASY OPEN ARTHRITIS CAP (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC.]19Current NDC, Legacy NDC, 12 package rows20250411_94f09ef7-0695-4499-83c1-95f1e42baf98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849728Aleve 220 MG Oral TabletPSN94f09ef7-0695-4499-83c1-95f1e42baf9819
849574naproxen sodium 220 MG Oral TabletPSN94f09ef7-0695-4499-83c1-95f1e42baf9819
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBD94f09ef7-0695-4499-83c1-95f1e42baf9819
849574naproxen sodium 220 MG Oral TabletSCD94f09ef7-0695-4499-83c1-95f1e42baf9819
849728Aleve 220 MG Oral TabletSY94f09ef7-0695-4499-83c1-95f1e42baf9819
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY94f09ef7-0695-4499-83c1-95f1e42baf9819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-6050-0100280605001100 TABLET in 1 BOTTLE (0280-6050-01) 100 tablet2013-11-110000-00-00NoNoCurrent
0280-6050-020028060500224 TABLET in 1 BOTTLE (0280-6050-02) 24 tablet2020-06-110000-00-00NoNoCurrent
0280-6050-03002806050031 BOTTLE in 1 CARTON (0280-6050-03) / 130 TABLET in 1 BOTTLE1 bottle2013-11-110000-00-00NoNoCurrent
0280-6050-04002806050041 BOTTLE in 1 CARTON (0280-6050-04) / 150 TABLET in 1 BOTTLE1 bottle2013-11-110000-00-00NoNoCurrent
0280-6050-0500280605005110 TABLET in 1 BOTTLE (0280-6050-05) 110 tablet2021-07-010000-00-00NoNoCurrent
0280-6050-060028060500690 TABLET in 1 BOTTLE (0280-6050-06) 90 tablet2021-07-010000-00-00NoNoCurrent
0280-6050-27002806050271 BOTTLE in 1 CARTON (0280-6050-27) / 270 TABLET in 1 BOTTLE1 bottle2013-11-110000-00-00NoNoCurrent
0280-6050-50002806050501 BOTTLE in 1 CARTON (0280-6050-50) / 50 TABLET in 1 BOTTLE1 bottle2013-11-110000-00-00NoNoCurrent