FDA.reportPublic FDA data

Aleve

Product NDC
0280-0114
11-digit product format
002800114
Labeler code
0280
Product ID
0280-0114_4cd9cec2-0e06-99a3-e063-6394a90a1943
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aleve
Brand name suffix
Caplets
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

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
0280-0114-01AleveCaplets1 in 1 CARTONTABLET13
0280-0114-01AleveCaplets200 in 1 BOTTLETABLET2003
0280-0114-02AleveCaplets1 in 1 CARTONTABLET13
0280-0114-02AleveCaplets24 in 1 BOTTLETABLET243
0280-0114-03AleveCaplets50 in 1 BOTTLETABLET503
0280-0114-03AleveCaplets1 in 1 CARTONTABLET13
0280-0114-04AleveCaplets90 in 1 BOTTLETABLET903
0280-0114-04AleveCaplets1 in 1 CARTONTABLET13
0280-0114-05AleveCaplets110 in 1 BOTTLETABLET1103
0280-0114-05AleveCaplets1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0114ALEVE CAPLETS (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC.]2Current NDC, 10 package rows20250403_02941928-128a-2c88-e063-6294a90ac6ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849728Aleve 220 MG Oral TabletPSN02941928-128a-2c88-e063-6294a90ac6ba3
849574naproxen sodium 220 MG Oral TabletPSN02941928-128a-2c88-e063-6294a90ac6ba3
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBD02941928-128a-2c88-e063-6294a90ac6ba3
849574naproxen sodium 220 MG Oral TabletSCD02941928-128a-2c88-e063-6294a90ac6ba3
849728Aleve 220 MG Oral TabletSY02941928-128a-2c88-e063-6294a90ac6ba3
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY02941928-128a-2c88-e063-6294a90ac6ba3
849728Aleve 220 MG Oral TabletPSN3ca84972-f8c9-1881-e063-6294a90a90702
849574naproxen sodium 220 MG Oral TabletPSN3ca84972-f8c9-1881-e063-6294a90a90702
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBD3ca84972-f8c9-1881-e063-6294a90a90702
849574naproxen sodium 220 MG Oral TabletSCD3ca84972-f8c9-1881-e063-6294a90a90702
849728Aleve 220 MG Oral TabletSY3ca84972-f8c9-1881-e063-6294a90a90702
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY3ca84972-f8c9-1881-e063-6294a90a90702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0280-0114-01002800114011 BOTTLE in 1 CARTON (0280-0114-01) / 200 TABLET in 1 BOTTLE1 bottle2024-03-25NoNoCurrent
0280-0114-02002800114021 BOTTLE in 1 CARTON (0280-0114-02) / 24 TABLET in 1 BOTTLE1 bottle2024-03-25NoNoCurrent
0280-0114-03002800114031 BOTTLE in 1 CARTON (0280-0114-03) / 50 TABLET in 1 BOTTLE1 bottle2024-03-25NoNoCurrent
0280-0114-04002800114041 BOTTLE in 1 CARTON (0280-0114-04) / 90 TABLET in 1 BOTTLE1 bottle2024-03-25NoNoCurrent
0280-0114-05002800114051 BOTTLE in 1 CARTON (0280-0114-05) / 110 TABLET in 1 BOTTLE1 bottle2024-03-25NoNoCurrent
0280-0114-0800280011408270 TABLET in 1 BOTTLE (0280-0114-08) 270 tablet2024-03-25NoNoCurrent