FDA.reportPublic FDA data

Aleve

Product NDC
0280-6080
11-digit product format
002806080
Labeler code
0280
Product ID
0280-6080_4526c253-b571-1d84-e063-6394a90ae3f9
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA021920
Marketing category
NDA
Marketing start
2007-02-20
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
Rxcui1112231, 1112233

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-6080-01Aleve1 in 1 CARTONCAPSULE, LIQUID FILLED116
0280-6080-01Aleve120 in 1 BOTTLECAPSULE, LIQUID FILLED12016
0280-6080-02Aleve2 in 1 PACKAGE, COMBINATIONCAPSULE, LIQUID FILLED216
0280-6080-02Aleve80 in 1 BOTTLECAPSULE, LIQUID FILLED8016
0280-6080-03Aleve52 in 1 BOTTLECAPSULE, LIQUID FILLED5216
0280-6080-04Aleve1 in 1 CARTONCAPSULE, LIQUID FILLED116
0280-6080-04Aleve50 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED5016
0280-6080-16Aleve160 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED16016
0280-6080-20Aleve1 in 1 CARTONCAPSULE, LIQUID FILLED116
0280-6080-20Aleve20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2016
0280-6080-40Aleve40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED4016
0280-6080-40Aleve1 in 1 CARTONCAPSULE, LIQUID FILLED116
0280-6080-80Aleve1 in 1 CARTONCAPSULE, LIQUID FILLED116
0280-6080-80Aleve80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED8016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-6080-16EA - Each0280-60809635414a-5393-405a-818c-14d2a9fb9cc512024-04-05
0280-6080-20EA - Each0280-6080f358a583-a9f8-4dc3-990b-09eeaf4305aa12022-08-04
0280-6080-40EA - Each0280-6080a8099631-abc3-46af-bcb1-70c65ed590f212018-04-19
0280-6080-80EA - Each0280-6080f8cf155a-2987-4ba9-b6b8-b4d3332623b212022-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Naproxen SodiumACTIVE INGREDIENT9TN87S3A3CALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
NaproxenACTIVE MOIETY57Y76R9ATQALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
FD&C blue NO. 1INACTIVE INGREDIENTH3R47K3TBDALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
gelatinINACTIVE INGREDIENT2G86QN327LALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
lactic acidINACTIVE INGREDIENT33X04XA5ATALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
mannitolINACTIVE INGREDIENT3OWL53L36AALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
povidone k30INACTIVE INGREDIENTU725QWY32XALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
sorbitanINACTIVE INGREDIENT6O92ICV9RUALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
sorbitolINACTIVE INGREDIENT506T60A25RALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
waterINACTIVE INGREDIENT059QF0KO0RALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-6080ALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.]15Current NDC, Legacy NDC, 14 package rows20231201_1266393e-b55e-4e34-9710-0b87209f4158.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1112233Aleve 220 MG Oral CapsulePSN1266393e-b55e-4e34-9710-0b87209f415816
1112231naproxen sodium 220 MG Oral CapsulePSN1266393e-b55e-4e34-9710-0b87209f415816
1112233naproxen sodium 220 MG Oral Capsule [Aleve]SBD1266393e-b55e-4e34-9710-0b87209f415816
1112231naproxen sodium 220 MG Oral CapsuleSCD1266393e-b55e-4e34-9710-0b87209f415816
1112233Aleve 220 MG (naproxen 200 MG) Oral CapsuleSY1266393e-b55e-4e34-9710-0b87209f415816
1112233Aleve 220 MG Oral CapsuleSY1266393e-b55e-4e34-9710-0b87209f415816
1112231naproxen sodium 220 MG (as naproxen 200 MG) Oral CapsuleSY1266393e-b55e-4e34-9710-0b87209f415816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-6080-01002806080011 BOTTLE in 1 CARTON (0280-6080-01) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2007-02-200000-00-00NoNoCurrent
0280-6080-02002806080022 BOTTLE in 1 PACKAGE, COMBINATION (0280-6080-02) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE2 bottle2007-02-200000-00-00NoNoCurrent
0280-6080-030028060800352 CAPSULE, LIQUID FILLED in 1 BOTTLE (0280-6080-03) 2007-02-202021-06-29NoNoCurrent
0280-6080-04002806080041 BOTTLE, PLASTIC in 1 CARTON (0280-6080-04) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2022-10-200000-00-00NoNoCurrent
0280-6080-1600280608016160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-6080-16) 2007-02-200000-00-00NoNoCurrent
0280-6080-20002806080201 BOTTLE, PLASTIC in 1 CARTON (0280-6080-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2007-02-200000-00-00NoNoCurrent
0280-6080-40002806080401 BOTTLE, PLASTIC in 1 CARTON (0280-6080-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2007-02-200000-00-00NoNoCurrent
0280-6080-80002806080801 BOTTLE, PLASTIC in 1 CARTON (0280-6080-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2007-02-200000-00-00NoNoCurrent