FDA.reportPublic FDA data

Aleve

Product NDC
0280-6000
11-digit product format
002806000
Labeler code
0280
Product ID
0280-6000_4526b744-fa15-0f7b-e063-6394a90a916e
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare LLC.
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
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
0280-6000-01AleveCaplets24 in 1 BOTTLETABLET2417
0280-6000-02AleveCaplets1 in 1 CARTONTABLET117
0280-6000-02AleveCaplets200 in 1 BOTTLETABLET20017
0280-6000-03AleveCaplets130 in 1 BOTTLETABLET13017
0280-6000-03AleveCaplets1 in 1 CARTONTABLET117
0280-6000-04AleveCaplets1 in 1 CARTONTABLET117
0280-6000-04AleveCaplets225 in 1 BOTTLETABLET22517
0280-6000-05AleveCaplets1 in 1 CARTONTABLET117
0280-6000-05AleveCaplets36 in 1 BOTTLETABLET3617
0280-6000-06AleveCaplets1 in 1 CARTONTABLET117
0280-6000-06AleveCaplets6 in 1 BLISTER PACKTABLET617
0280-6000-07AleveCaplets48 in 1 POUCHTABLET4817
0280-6000-08AleveCaplets65 in 1 BOTTLETABLET6517
0280-6000-08AleveCaplets1 in 1 CARTONTABLET117
0280-6000-09AleveCaplets1 in 1 POUCHTABLET117
0280-6000-10AleveCaplets100 in 1 BOTTLETABLET10017
0280-6000-10AleveCaplets1 in 1 CARTONTABLET117
0280-6000-12AleveCaplets90 in 1 BOTTLETABLET9017
0280-6000-12AleveCaplets1 in 1 CARTONTABLET117
0280-6000-15AleveCaplets150 in 1 BOTTLETABLET15017
0280-6000-15AleveCaplets1 in 1 CARTONTABLET117
0280-6000-16AleveCaplets1 in 1 POUCHTABLET117
0280-6000-24AleveCaplets24 in 1 BOTTLETABLET2417
0280-6000-24AleveCaplets1 in 1 CARTONTABLET117
0280-6000-27AleveCaplets270 in 1 BOTTLETABLET27017
0280-6000-32AleveCaplets320 in 1 BOTTLETABLET32017
0280-6000-32AleveCaplets1 in 1 CARTONTABLET117
0280-6000-50AleveCaplets50 in 1 BOTTLETABLET5017
0280-6000-50AleveCaplets1 in 1 CARTONTABLET117
0280-6000-70AleveCaplets1 in 1 CARTONTABLET117
0280-6000-70AleveCaplets150 in 1 BOTTLETABLET15017
0280-6000-75AleveCaplets180 in 1 BOTTLETABLET18017
0280-6000-75AleveCaplets1 in 1 CARTONTABLET117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-6000-10EA - Each0280-60003d7e705c-0aa1-49a0-b403-7f22091eab5412022-02-07
0280-6000-24EA - Each0280-6000b221ea71-b2e4-474c-a035-30da3e9e65e512021-07-15
0280-6000-32EA - Each0280-6000d95d3b04-0998-4a1e-8379-c0a2c5ac0cd212014-09-03
0280-6000-50EA - Each0280-6000e24c97ad-b92b-4c49-a641-af94b290daa012023-07-06

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-6000ALEVE CAPLETS (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC.]16Current NDC, Legacy NDC, 33 package rows20221201_a3745850-3e32-4884-b315-161bcb9996ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849728Aleve 220 MG Oral TabletPSNa3745850-3e32-4884-b315-161bcb9996ed17
849574naproxen sodium 220 MG Oral TabletPSNa3745850-3e32-4884-b315-161bcb9996ed17
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBDa3745850-3e32-4884-b315-161bcb9996ed17
849574naproxen sodium 220 MG Oral TabletSCDa3745850-3e32-4884-b315-161bcb9996ed17
849728Aleve 220 MG Oral TabletSYa3745850-3e32-4884-b315-161bcb9996ed17
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYa3745850-3e32-4884-b315-161bcb9996ed17
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
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
849728Aleve 220 MG Oral TabletPSNc95dceed-4968-486f-aecf-2942eda41a952
849574naproxen sodium 220 MG Oral TabletPSNc95dceed-4968-486f-aecf-2942eda41a952
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBDc95dceed-4968-486f-aecf-2942eda41a952
849574naproxen sodium 220 MG Oral TabletSCDc95dceed-4968-486f-aecf-2942eda41a952
849728Aleve 220 MG Oral TabletSYc95dceed-4968-486f-aecf-2942eda41a952
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYc95dceed-4968-486f-aecf-2942eda41a952
849728Aleve 220 MG Oral TabletPSNf758201c-28b8-5357-e053-6394a90a1e5d1
849728Aleve 220 MG Oral TabletPSNaa9dfc22-a5e4-432b-b7c8-bdddfdab9d111
849574naproxen sodium 220 MG Oral TabletPSNaa9dfc22-a5e4-432b-b7c8-bdddfdab9d111
849574naproxen sodium 220 MG Oral TabletPSNf758201c-28b8-5357-e053-6394a90a1e5d1
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBDf758201c-28b8-5357-e053-6394a90a1e5d1
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBDaa9dfc22-a5e4-432b-b7c8-bdddfdab9d111
849574naproxen sodium 220 MG Oral TabletSCDaa9dfc22-a5e4-432b-b7c8-bdddfdab9d111
849574naproxen sodium 220 MG Oral TabletSCDf758201c-28b8-5357-e053-6394a90a1e5d1
849728Aleve 220 MG Oral TabletSYaa9dfc22-a5e4-432b-b7c8-bdddfdab9d111
849728Aleve 220 MG Oral TabletSYf758201c-28b8-5357-e053-6394a90a1e5d1
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYaa9dfc22-a5e4-432b-b7c8-bdddfdab9d111
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 startMarketing endSampleExclude flagStatus
0280-6000-010028060000124 TABLET in 1 BOTTLE (0280-6000-01) 24 tablet2014-02-260000-00-00NoNoCurrent
0280-6000-02002806000021 BOTTLE in 1 CARTON (0280-6000-02) / 200 TABLET in 1 BOTTLE1 bottle2014-03-260000-00-00NoNoCurrent
0280-6000-03002806000031 BOTTLE in 1 CARTON (0280-6000-03) / 130 TABLET in 1 BOTTLE1 bottle2014-02-260000-00-00NoNoCurrent
0280-6000-04002806000041 BOTTLE in 1 CARTON (0280-6000-04) / 225 TABLET in 1 BOTTLE1 bottle2014-02-260000-00-00NoNoCurrent
0280-6000-05002806000051 BOTTLE in 1 CARTON (0280-6000-05) / 36 TABLET in 1 BOTTLE1 bottle2014-02-260000-00-00NoNoCurrent
0280-6000-06002806000061 BLISTER PACK in 1 CARTON (0280-6000-06) / 6 TABLET in 1 BLISTER PACK1 blister pack2014-02-260000-00-00NoNoCurrent
0280-6000-070028060000748 TABLET in 1 POUCH (0280-6000-07) 48 tablet2014-02-260000-00-00NoNoCurrent
0280-6000-08002806000081 BOTTLE in 1 CARTON (0280-6000-08) / 65 TABLET in 1 BOTTLE1 bottle2014-02-260000-00-00NoNoCurrent
0280-6000-09002806000091 TABLET in 1 POUCH (0280-6000-09) 1 tablet2020-07-010000-00-00NoNoCurrent
0280-6000-10002806000101 BOTTLE in 1 CARTON (0280-6000-10) > 100 TABLET in 1 BOTTLE1 bottle2014-02-260000-00-00NoNoCurrent
0280-6000-12002806000121 BOTTLE in 1 CARTON (0280-6000-12) / 90 TABLET in 1 BOTTLE1 bottle2021-07-010000-00-00NoNoCurrent
0280-6000-140028060001460 TABLET in 1 POUCH (0280-6000-14) 60 tablet2021-07-310000-00-00NoNoCurrent
0280-6000-15002806000151 BOTTLE in 1 CARTON (0280-6000-15) > 150 TABLET in 1 BOTTLE1 bottle2014-02-260000-00-00NoNoCurrent
0280-6000-16002806000161 TABLET in 1 POUCH (0280-6000-16) 1 tablet2021-07-010000-00-00YesNoCurrent
0280-6000-24002806000241 BOTTLE in 1 CARTON (0280-6000-24) / 24 TABLET in 1 BOTTLE1 bottle2014-02-260000-00-00NoNoCurrent
0280-6000-2700280600027270 TABLET in 1 BOTTLE (0280-6000-27) 270 tablet2021-07-010000-00-00NoNoCurrent
0280-6000-32002806000321 BOTTLE in 1 CARTON (0280-6000-32) / 320 TABLET in 1 BOTTLE1 bottle2014-02-260000-00-00NoNoCurrent
0280-6000-50002806000501 BOTTLE in 1 CARTON (0280-6000-50) / 50 TABLET in 1 BOTTLE1 bottle2014-02-260000-00-00NoNoCurrent
0280-6000-70002806000701 BOTTLE in 1 CARTON (0280-6000-70) / 150 TABLET in 1 BOTTLE1 bottle2016-03-18NoNoHistorical
0280-6000-7500280600075180 in 1 BOTTLEHistorical