FDA.reportPublic FDA data

Aleve

Product NDC
85237-1832
11-digit product format
852371832
Labeler code
85237
Product ID
85237-1832_46fdc753-1f23-d8ce-e063-6294a90a86e5
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Select Consumer Group
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
Brand name suffix
Caplets
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
85237-1832-1AleveCaplets1 in 1 BLISTER PACKTABLET12
85237-1832-1AleveCaplets1 in 1 POUCHTABLET12
85237-1832-2AleveCaplets2 in 1 BLISTER PACKTABLET22
85237-1832-2AleveCaplets1 in 1 POUCHTABLET12
85237-1832-4AleveCaplets1 in 1 POUCHTABLET12
85237-1832-4AleveCaplets25 in 1 BOX, UNIT-DOSETABLET252
85237-1832-6AleveCaplets50 in 1 BOX, UNIT-DOSETABLET502
85237-1832-6AleveCaplets1 in 1 POUCHTABLET12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
85237-1832-1852371832011 POUCH in 1 BLISTER PACK (85237-1832-1) / 1 TABLET in 1 POUCH1 pouch2024-03-25NoNoCurrent
85237-1832-2852371832022 POUCH in 1 BLISTER PACK (85237-1832-2) / 1 TABLET in 1 POUCH2 pouch2025-12-24NoNoCurrent
85237-1832-48523718320425 POUCH in 1 BOX, UNIT-DOSE (85237-1832-4) / 1 TABLET in 1 POUCH25 pouch2025-12-24NoNoCurrent
85237-1832-68523718320650 POUCH in 1 BOX, UNIT-DOSE (85237-1832-6) / 1 TABLET in 1 POUCH50 pouch2025-12-24NoNoCurrent