Aleve

Product NDC
0280-8252
11-digit product format
002808252
Labeler code
0280
Product ID
0280-8252_3ba28e47-1293-bec7-e063-6294a90ac80a
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
9TN87S3A3CNAPROXEN SODIUM26159-34-2NAPROXEN SODIUM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0280-8252-100028082521010 TABLET in 1 BOTTLE (0280-8252-10) 10 tablet2024-09-11NoNoHistorical
0280-8252-24002808252241 BOTTLE in 1 CARTON (0280-8252-24) / 24 TABLET in 1 BOTTLE1 bottle2025-04-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Aleve ® Toothache Pain - Blueshield UI 1614642Bayer HealthCare LLC.2025-08-05HUMAN OTC DRUG LABEL1