FDA.reportPublic FDA data

Bayer Aleve

Product NDC
0924-6000
11-digit product format
009246000
Labeler code
0924
Product ID
0924-6000_f7582032-efbd-5f5b-e053-6394a90a994e
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Acme United Corporation
Application
NDA020204
Marketing category
NDA
Marketing start
2023-03-24
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
Bayer 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
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
0924-6000-00Bayer Aleve1 in 1 POUCHTABLET11
0924-6000-01Bayer Aleve50 in 1 BOXTABLET501
0924-6000-01Bayer Aleve1 in 1 POUCHTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-6000BAYER ALEVE (NAPROXEN SODIUM) TABLET [ACME UNITED CORPORATION]1Current NDC, 3 package rows20230324_f758201c-28b8-5357-e053-6394a90a1e5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849728Aleve 220 MG Oral TabletPSNf758201c-28b8-5357-e053-6394a90a1e5d1
849574naproxen sodium 220 MG Oral TabletPSNf758201c-28b8-5357-e053-6394a90a1e5d1
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBDf758201c-28b8-5357-e053-6394a90a1e5d1
849574naproxen sodium 220 MG Oral TabletSCDf758201c-28b8-5357-e053-6394a90a1e5d1
849728Aleve 220 MG Oral TabletSYf758201c-28b8-5357-e053-6394a90a1e5d1
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYf758201c-28b8-5357-e053-6394a90a1e5d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0924-6000-00009246000001 TABLET in 1 POUCH (0924-6000-00) 1 tablet2023-03-24NoNoCurrent
0924-6000-010092460000150 POUCH in 1 BOX (0924-6000-01) / 1 TABLET in 1 POUCH50 pouch2023-03-24NoNoCurrent