FDA.reportPublic FDA data

Aleve

Product NDC
0280-0113
11-digit product format
002800113
Labeler code
0280
Product ID
0280-0113_31bad2d9-c0ba-7f20-e063-6294a90acb17
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA020204
Marketing category
NDA
Marketing start
2023-04-04
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0113-01Aleve10 in 1 BOTTLETABLET101
0280-0113-02Aleve24 in 1 BOTTLETABLET241
0280-0113-02Aleve1 in 1 CARTONTABLET11
0280-0113-03Aleve270 in 1 BOTTLETABLET2701
0280-0113-03Aleve1 in 1 CARTONTABLET11
0280-0113-04Aleve50 in 1 BOTTLETABLET501
0280-0113-04Aleve1 in 1 CARTONTABLET11
0280-0113-05Aleve1 in 1 CARTONTABLET11
0280-0113-05Aleve90 in 1 BOTTLETABLET901
0280-0113-06Aleve1 in 1 CARTONTABLET11
0280-0113-06Aleve110 in 1 BOTTLETABLET1101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849728Aleve 220 MG Oral TabletPSN31bad2d9-c0bb-7f20-e063-6294a90acb171
849574naproxen sodium 220 MG Oral TabletPSN31bad2d9-c0bb-7f20-e063-6294a90acb171
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBD31bad2d9-c0bb-7f20-e063-6294a90acb171
849574naproxen sodium 220 MG Oral TabletSCD31bad2d9-c0bb-7f20-e063-6294a90acb171
849728Aleve 220 MG Oral TabletSY31bad2d9-c0bb-7f20-e063-6294a90acb171
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY31bad2d9-c0bb-7f20-e063-6294a90acb171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0280-0113-010028001130110 TABLET in 1 BOTTLE (0280-0113-01) 10 tablet2024-03-25NoNoHistorical
0280-0113-02002800113021 BOTTLE in 1 CARTON (0280-0113-02) / 24 TABLET in 1 BOTTLE1 bottle2024-04-04NoNoHistorical
0280-0113-03002800113031 BOTTLE in 1 CARTON (0280-0113-03) / 270 TABLET in 1 BOTTLE1 bottle2024-04-04NoNoHistorical
0280-0113-04002800113041 BOTTLE in 1 CARTON (0280-0113-04) / 50 TABLET in 1 BOTTLE1 bottle2024-04-04NoNoHistorical
0280-0113-05002800113051 BOTTLE in 1 CARTON (0280-0113-05) / 90 TABLET in 1 BOTTLE1 bottle2024-04-04NoNoHistorical
0280-0113-06002800113061 BOTTLE in 1 CARTON (0280-0113-06) / 110 TABLET in 1 BOTTLE1 bottle2024-04-04NoNoHistorical