FDA.reportPublic FDA data

Aleve

Product NDC
67751-144
11-digit product format
677510144
Labeler code
67751
Product ID
67751-144_4efb1f81-caf8-0cc8-e063-6394a90a8250
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
NDA020204
Marketing category
NDA
Marketing start
2016-09-17
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aleve
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67751-144-012023-03-01C16284748780-1f386c649-aed3-0266-e053-dadaa90a7c1aAleve
67751-144-022023-03-01C16284748780-1f386c649-aed3-0266-e053-dadaa90a7c1aAleve
67751-144-032023-03-01C16284748780-1f386c649-ac74-0266-e053-dadaa90a7c1aAleve
67751-144-042023-03-01C16284748780-1f386c649-ac74-0266-e053-dadaa90a7c1aAleve
67751-144-052023-03-01C16284748780-1f386c649-ac74-0266-e053-dadaa90a7c1aAleve
67751-144-012023-01-30C16284748780-1f386c649-aed3-0266-e053-dadaa90a7c1aAleve
67751-144-022023-01-30C16284748780-1f386c649-aed3-0266-e053-dadaa90a7c1aAleve
67751-144-032023-01-30C16284748780-1f386c649-ac74-0266-e053-dadaa90a7c1aAleve
67751-144-042023-01-30C16284748780-1f386c649-ac74-0266-e053-dadaa90a7c1aAleve
67751-144-052023-01-30C16284748780-1f386c649-ac74-0266-e053-dadaa90a7c1aAleve

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-144-01Aleve1 in 1 POUCHTABLET15
67751-144-01Aleve1 in 1 CARTONTABLET15
67751-144-02Aleve2 in 1 POUCHTABLET25
67751-144-02Aleve1 in 1 CARTONTABLET15
67751-144-06Aleve3 in 1 CARTONTABLET35
67751-144-06Aleve1 in 1 POUCHTABLET15
67751-144-03Aleve1 in 1 CARTONTABLET13
67751-144-03Aleve1 in 1 POUCHTABLET13
67751-144-04Aleve2 in 1 CARTONTABLET23
67751-144-04Aleve1 in 1 POUCHTABLET13
67751-144-05Aleve12 in 1 TRAYTABLET123
67751-144-05Aleve1 in 1 POUCHTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-144ALEVE (NAPROXEN SODIUM) TABLET [NAVAJO MANUFACTURING COMPANY INC]3Current NDC, Legacy NDC, 6 package rows20230302_60637aeb-deb6-4747-e053-2a91aa0ad00b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849728Aleve 220 MG Oral TabletPSN590f3be2-20df-4643-9114-e7ed4cf9155c5
849574naproxen sodium 220 MG Oral TabletPSN590f3be2-20df-4643-9114-e7ed4cf9155c5
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBD590f3be2-20df-4643-9114-e7ed4cf9155c5
849574naproxen sodium 220 MG Oral TabletSCD590f3be2-20df-4643-9114-e7ed4cf9155c5
849728Aleve 220 MG Oral TabletSY590f3be2-20df-4643-9114-e7ed4cf9155c5
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY590f3be2-20df-4643-9114-e7ed4cf9155c5
849728Aleve 220 MG Oral TabletPSN60637aeb-deb6-4747-e053-2a91aa0ad00b3
849574naproxen sodium 220 MG Oral TabletPSN60637aeb-deb6-4747-e053-2a91aa0ad00b3
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBD60637aeb-deb6-4747-e053-2a91aa0ad00b3
849574naproxen sodium 220 MG Oral TabletSCD60637aeb-deb6-4747-e053-2a91aa0ad00b3
849728Aleve 220 MG Oral TabletSY60637aeb-deb6-4747-e053-2a91aa0ad00b3
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY60637aeb-deb6-4747-e053-2a91aa0ad00b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-144-01677510144011 POUCH in 1 CARTON (67751-144-01) / 1 TABLET in 1 POUCH1 pouch2016-09-170000-00-00NoNoCurrent
67751-144-02677510144021 POUCH in 1 CARTON (67751-144-02) / 2 TABLET in 1 POUCH1 pouch2016-09-170000-00-00NoNoCurrent
67751-144-03677510144031 POUCH in 1 CARTON (67751-144-03) / 1 TABLET in 1 POUCH1 pouch2017-12-040000-00-00NoNoCurrent
67751-144-04677510144042 POUCH in 1 CARTON (67751-144-04) / 1 TABLET in 1 POUCH2 pouch2017-12-040000-00-00NoNoCurrent
67751-144-056775101440512 POUCH in 1 TRAY (67751-144-05) > 1 TABLET in 1 POUCH12 pouch2017-12-040000-00-00NoNoCurrent
67751-144-06677510144063 POUCH in 1 CARTON (67751-144-06) / 1 TABLET in 1 POUCH3 pouch2025-04-22NoNoHistorical