FDA.reportPublic FDA data

Aleve

Product NDC
70264-011
11-digit product format
702640011
Labeler code
70264
Product ID
70264-011_43c866a6-dc20-5e19-e063-6294a90aac20
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
R J General Corporation
Application
NDA020204
Marketing category
NDA
Marketing start
2014-02-26
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70264-011-012022-09-21C16284748780-19d75b9d0-3679-f424-e053-dadaa90a57ceAleve ®
70264-011-012020-01-31C16284748780-19d75b9d0-3679-f424-e053-dadaa90a57ceAleve ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70264-011-01Aleve50 in 1 CARTONTABLET508
70264-011-01Aleve1 in 1 POUCHTABLET18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]1
NAPROXENACTIVE MOIETY57Y76R9ATQALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]1
TALCINACTIVE INGREDIENT7SEV7J4R1UALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70264-011ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]7Current NDC, Legacy NDC, 2 package rows20241112_46e7b298-9e19-49b6-be71-e4fdcb09a5d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849728Aleve 220 MG Oral TabletPSN46e7b298-9e19-49b6-be71-e4fdcb09a5d48
849574naproxen sodium 220 MG Oral TabletPSN46e7b298-9e19-49b6-be71-e4fdcb09a5d48
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBD46e7b298-9e19-49b6-be71-e4fdcb09a5d48
849574naproxen sodium 220 MG Oral TabletSCD46e7b298-9e19-49b6-be71-e4fdcb09a5d48
849728Aleve 220 MG Oral TabletSY46e7b298-9e19-49b6-be71-e4fdcb09a5d48
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY46e7b298-9e19-49b6-be71-e4fdcb09a5d48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70264-011-017026400110150 POUCH in 1 CARTON (70264-011-01) / 1 TABLET in 1 POUCH50 pouch2014-02-260000-00-00NoNoCurrent