Aleve Headache Pain

Product NDC
0280-0041
11-digit product format
002800041
Labeler code
0280
Product ID
0280-0041_45261837-3574-4376-e063-6394a90af7a7
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare LLC
Application
NDA020204
Marketing category
NDA
Marketing start
2021-06-01
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 Headache Pain
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
0280-0041-01Aleve Headache Pain1 in 1 CARTONTABLET14
0280-0041-01Aleve Headache Pain175 in 1 BOTTLETABLET1754
0280-0041-02Aleve Headache Pain50 in 1 BOTTLETABLET504
0280-0041-02Aleve Headache Pain1 in 1 CARTONTABLET14
0280-0041-03Aleve Headache Pain1 in 1 CARTONTABLET14
0280-0041-03Aleve Headache Pain90 in 1 BOTTLETABLET904
0280-0041-04Aleve Headache Pain1 in 1 CARTONTABLET14
0280-0041-04Aleve Headache Pain24 in 1 BOTTLETABLET244
0280-0041-05Aleve Headache Pain1 in 1 POUCHTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0041ALEVE HEADACHE PAIN (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC]3Current NDC, Legacy NDC, 9 package rows20241208_c69f4926-c5cd-63a0-e053-2a95a90a2ca6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849728Aleve 220 MG Oral TabletPSNc69f4926-c5cd-63a0-e053-2a95a90a2ca64
849574naproxen sodium 220 MG Oral TabletPSNc69f4926-c5cd-63a0-e053-2a95a90a2ca64
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBDc69f4926-c5cd-63a0-e053-2a95a90a2ca64
849574naproxen sodium 220 MG Oral TabletSCDc69f4926-c5cd-63a0-e053-2a95a90a2ca64
849728Aleve 220 MG Oral TabletSYc69f4926-c5cd-63a0-e053-2a95a90a2ca64
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYc69f4926-c5cd-63a0-e053-2a95a90a2ca64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-0041-01002800041011 BOTTLE in 1 CARTON (0280-0041-01) / 175 TABLET in 1 BOTTLE1 bottle2021-06-010000-00-00NoNoCurrent
0280-0041-02002800041021 BOTTLE in 1 CARTON (0280-0041-02) / 50 TABLET in 1 BOTTLE1 bottle2021-06-010000-00-00NoNoCurrent
0280-0041-03002800041031 BOTTLE in 1 CARTON (0280-0041-03) / 90 TABLET in 1 BOTTLE1 bottle2021-06-010000-00-00NoNoCurrent
0280-0041-04002800041041 BOTTLE in 1 CARTON (0280-0041-04) / 24 TABLET in 1 BOTTLE1 bottle2021-06-010000-00-00NoNoCurrent
0280-0041-05002800041051 TABLET in 1 POUCH (0280-0041-05) 1 tablet2021-06-010000-00-00YesNoCurrent