FDA.reportPublic FDA data

naproxen sodium 220 MG Oral Capsule [Aleve]

RxCUI
1112233
RxNorm name
naproxen sodium 220 MG Oral Capsule [Aleve]
Display name
ALEVE (Oral Pill)
Full name
naproxen sodium 220 MG Oral Capsule [Aleve]
Term type
SBD
Status
Active
Strength
220 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-10-15 15:42:42

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
072011
Active start
072011
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
naproxen sodium220 MG / 1 EACHnaproxennaproxen sodium

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Capsule316965

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
naproxen7258

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRAleve 220 MG Oral Capsule1NAMES
RxNorm Namenaproxen sodium 220 MG Oral Capsule [Aleve]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI11122331CODES
MMSL_CODEBD271991CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0280-0105-010280-0105Aleve liquid gels Naproxen SodiumBayer Healthcare LLCANDA214463
0280-0105-020280-0105Aleve liquid gels Naproxen SodiumBayer Healthcare LLCANDA214463
0280-0105-030280-0105Aleve liquid gels Naproxen SodiumBayer Healthcare LLCANDA214463
0280-0105-040280-0105Aleve liquid gels Naproxen SodiumBayer Healthcare LLCANDA214463
0280-0105-050280-0105Aleve liquid gels Naproxen SodiumBayer Healthcare LLCANDA214463
0280-0105-060280-0105Aleve liquid gels Naproxen SodiumBayer Healthcare LLCANDA214463
0280-6080-010280-6080Aleve Naproxen SodiumBayer HealthCare LLC.NDA021920
0280-6080-020280-6080Aleve Naproxen SodiumBayer HealthCare LLC.NDA021920
0280-6080-040280-6080Aleve Naproxen SodiumBayer HealthCare LLC.NDA021920
0280-6080-160280-6080Aleve Naproxen SodiumBayer HealthCare LLC.NDA021920
0280-6080-200280-6080Aleve Naproxen SodiumBayer HealthCare LLC.NDA021920
0280-6080-400280-6080Aleve Naproxen SodiumBayer HealthCare LLC.NDA021920
0280-6080-800280-6080Aleve Naproxen SodiumBayer HealthCare LLC.NDA021920
0280-6091-800280-6091Aleve Naproxen SodiumBayer HealthCare LLC.NDA021920

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA2144630280-0105Aleve liquid gels Naproxen SodiumANDABayer Healthcare LLC
NDA0219200280-6080Aleve Naproxen SodiumNDABayer HealthCare LLC.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 24 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00280010501rxnav_ndcsyes
00280010502rxnav_ndcsyes
00280010503rxnav_ndcsyes
00280010504rxnav_ndcsyes
00280010505rxnav_ndcsyes
00280010506rxnav_ndcsyes
00280608001rxnav_ndcsyes
00280608002rxnav_ndcsyes
00280608004rxnav_ndcsyes
00280608016rxnav_ndcsyes
00280608020rxnav_ndcsyes
00280608040rxnav_ndcsyes
00280608080rxnav_ndcsyes
00280609180rxnav_ndcsyes
25866052782rxnav_ndcsyes
25866052812rxnav_ndcsyes
25866052813rxnav_ndcsyes
25866052814rxnav_ndcsyes
25866053590rxnav_ndcsyes
25866055834rxnav_ndcsyes
25866056155rxnav_ndcsyes
25866058005rxnav_ndcsyes
00280608003rxnav_historical
00280609080rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AleveNAPROXEN SODIUMBayer HealthCare LLC.1266393e-b55e-4e34-9710-0b87209f41582025-12-04WarningsExact identifier
ndc (package): 0280-6080-01
ndc (package): 0280-6080-04
ndc (package): 0280-6080-40
ndc (package): 0280-6080-80
ndc (package): 0280-6080-16
ndc (package): 0280-6080-20
ndc (package): 0280-6080-02
ndc (product): 0280-6080
ndc11 (package): 00280608004
ndc11 (package): 00280608003
ndc11 (package): 00280608001
ndc11 (package): 00280608016
ndc11 (package): 00280608020
ndc11 (package): 00280608080
ndc11 (package): 00280608002
ndc11 (package): 00280608040
rxcui: 1112233
Aleve Easy Open Arthritis CapNAPROXEN SODIUMBayer HealthCare LLC.3b5442c6-c6e1-4df3-8cec-40bbb4ec469f2025-12-04WarningsExact identifier
ndc (package): 0280-6091-80
ndc (product): 0280-6091
ndc11 (package): 00280609180
rxcui: 1112233
Aleve liquid gelsNAPROXEN SODIUMBayer Healthcare LLCa0587c73-d297-462d-a0ef-750cb324486e2024-05-06WarningsExact identifier
ndc (package): 0280-0105-06
ndc (package): 0280-0105-01
ndc (package): 0280-0105-04
ndc (package): 0280-0105-03
ndc (package): 0280-0105-05
ndc (package): 0280-0105-02
ndc (product): 0280-0105
ndc11 (package): 00280010505
ndc11 (package): 00280010503
ndc11 (package): 00280010502
ndc11 (package): 00280010504
ndc11 (package): 00280010506
ndc11 (package): 00280010501
rxcui: 1112233

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
1266393e-b55e-4e34-9710-0b87209f4158Aleve 220 MG Oral Capsule [PSN] · naproxen sodium 220 MG Oral Capsule [Aleve] [SBD] · Aleve 220 MG (naproxen 200 MG) Oral Capsule [SY] · Aleve 220 MG Oral Capsule [SY]416ALEVE ® LIQUID GELS20251204
3b5442c6-c6e1-4df3-8cec-40bbb4ec469fAleve 220 MG Oral Capsule [PSN] · naproxen sodium 220 MG Oral Capsule [Aleve] [SBD] · Aleve 220 MG (naproxen 200 MG) Oral Capsule [SY] · Aleve 220 MG Oral Capsule [SY]411ALEVE ® LIQUID GELS20251204
a0587c73-d297-462d-a0ef-750cb324486eAleve 220 MG Oral Capsule [PSN] · naproxen sodium 220 MG Oral Capsule [Aleve] [SBD] · Aleve 220 MG (naproxen 200 MG) Oral Capsule [SY] · Aleve 220 MG Oral Capsule [SY]42ALEVE LIQUID GELS20240506

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
1266393e-b55e-4e34-9710-0b87209f4158ALEVE ® LIQUID GELSBayer HealthCare LLC.20251204
3b5442c6-c6e1-4df3-8cec-40bbb4ec469fALEVE ® LIQUID GELSBayer HealthCare LLC.20251204
a0587c73-d297-462d-a0ef-750cb324486eALEVE LIQUID GELSBayer Healthcare LLC | Patheon Softgels Inc.20240506

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCM02AAAntiinflammatory preparations, non-steroids for topical useATC1-4naproxen
ATCG02CCAntiinflammatory products for vaginal administrationATC1-4naproxen
ATCM01AEPropionic acid derivativesATC1-4naproxen
FDASPLN0000175722Nonsteroidal Anti-inflammatory DrugEPChas_epcnaproxen
FDASPLN0000000160Cyclooxygenase InhibitorsMOAhas_moanaproxen
MEDRTD009288NaproxenCHEMhas_ingredientnaproxen
MEDRTD009288NaproxenCHEMhas_ingredientnaproxen sodium
MEDRTD001171Arthritis, JuvenileDISEASEmay_treatnaproxen sodium
MEDRTD001171Arthritis, JuvenileDISEASEmay_treatnaproxen
MEDRTD001172Arthritis, RheumatoidDISEASEmay_treatnaproxen sodium
MEDRTD001172Arthritis, RheumatoidDISEASEmay_treatnaproxen
MEDRTD001416Back PainDISEASEmay_treatnaproxen sodium
MEDRTD001416Back PainDISEASEmay_treatnaproxen
MEDRTD002062BursitisDISEASEmay_treatnaproxen sodium
MEDRTD002062BursitisDISEASEmay_treatnaproxen
MEDRTD003139Common ColdDISEASEmay_treatnaproxen sodium
MEDRTD003139Common ColdDISEASEmay_treatnaproxen
MEDRTD004342Drug HypersensitivityDISEASEci_withnaproxen sodium
MEDRTD004342Drug HypersensitivityDISEASEci_withnaproxen
MEDRTD004412DysmenorrheaDISEASEmay_treatnaproxen sodium
MEDRTD004412DysmenorrheaDISEASEmay_treatnaproxen
MEDRTD005334FeverDISEASEmay_treatnaproxen sodium
MEDRTD005334FeverDISEASEmay_treatnaproxen
MEDRTD006073GoutDISEASEmay_treatnaproxen
MEDRTD006073GoutDISEASEmay_treatnaproxen sodium
MEDRTD006261HeadacheDISEASEmay_treatnaproxen sodium
MEDRTD006261HeadacheDISEASEmay_treatnaproxen
MEDRTD007249InflammationDISEASEmay_treatnaproxen
MEDRTD007249InflammationDISEASEmay_treatnaproxen sodium
MEDRTD010003OsteoarthritisDISEASEmay_treatnaproxen sodium
MEDRTD010003OsteoarthritisDISEASEmay_treatnaproxen
MEDRTD010146PainDISEASEmay_preventnaproxen
MEDRTD010146PainDISEASEmay_preventnaproxen sodium
MEDRTD011263Pregnancy Trimester, ThirdDISEASEci_withnaproxen
MEDRTD011263Pregnancy Trimester, ThirdDISEASEci_withnaproxen sodium
MEDRTD013167Spondylitis, AnkylosingDISEASEmay_treatnaproxen
MEDRTD013167Spondylitis, AnkylosingDISEASEmay_treatnaproxen sodium
MEDRTD014098ToothacheDISEASEmay_treatnaproxen
MEDRTD014098ToothacheDISEASEmay_treatnaproxen sodium
MEDRTN0000000160Cyclooxygenase InhibitorsMOAhas_moanaproxen sodium
MEDRTN0000000160Cyclooxygenase InhibitorsMOAhas_moanaproxen
MEDRTN0000008831Decreased Platelet Activating Factor ProductionPEhas_penaproxen sodium
MEDRTN0000008831Decreased Platelet Activating Factor ProductionPEhas_penaproxen
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_penaproxen sodium
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_penaproxen
MEDRTN0000009006Decreased Thromboxane ProductionPEhas_penaproxen
MEDRTN0000009006Decreased Thromboxane ProductionPEhas_penaproxen sodium
MEDRTN0000000042Renal ExcretionPKhas_pknaproxen
MEDRTN0000000042Renal ExcretionPKhas_pknaproxen sodium

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH220 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA214463
CODESNDANDA021920
NAMESPrescribable SynonymAleve 220 MG Oral Capsule
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon