FDA.reportPublic FDA data

diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral Tablet [Aleve PM]

RxCUI
1550963
RxNorm name
diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral Tablet [Aleve PM]
Display name
ALEVE PM (Oral Pill)
Full name
diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral Tablet [Aleve PM]
Term type
SBD
Status
Active
Strength
25-220 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-13 14:25:15

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112014
Active start
112014
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
diphenhydramine hydrochloride25 MG / 1 EACHdiphenhydraminediphenhydramine hydrochloride
naproxen sodium220 MG / 1 EACHnaproxennaproxen sodium

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
diphenhydramine3498
naproxen7258

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRAleve PM (diphenhydrAMINE hydrochloride 25 MG / naproxen sodium 220 MG) Oral Tablet1NAMES
RxNorm Namediphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral Tablet [Aleve PM]1NAMES
RxNorm SynonymAleve PM (diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG) Oral Tablet1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID82891458-ab0d-459a-8602-dcebd22c30101CODES
RxCUI15509631CODES
MMSL_CODEBD301911CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0280-1200-010280-1200Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDA205352
0280-1200-020280-1200Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDA205352
0280-1200-030280-1200Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDA205352
0280-1200-040280-1200Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDA205352
0280-1200-050280-1200Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDA205352
0280-1200-080280-1200Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDA205352
0280-1200-200280-1200Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDA205352
0280-1200-400280-1200Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDA205352
0280-1200-800280-1200Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMBayer HealthCare LLC.NDA205352

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA2053520280-1200Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUMNDABayer HealthCare LLC.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 14 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00280120001rxnav_ndcsyes
00280120002rxnav_ndcsyes
00280120003rxnav_ndcsyes
00280120004rxnav_ndcsyes
00280120005rxnav_ndcsyes
00280120008rxnav_ndcsyes
00280120020rxnav_ndcsyes
00280120040rxnav_ndcsyes
00280120080rxnav_ndcsyes
25866055306rxnav_ndcsyes
25866055307rxnav_ndcsyes
25866055308rxnav_ndcsyes
25866056028rxnav_ndcsyes
25866056029rxnav_ndcsyes

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aleve PMDIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUMBayer HealthCare LLC.82891458-ab0d-459a-8602-dcebd22c30102025-12-04WarningsExact identifier
ndc (package): 0280-1200-02
ndc (package): 0280-1200-04
ndc (package): 0280-1200-05
ndc (package): 0280-1200-03
ndc (package): 0280-1200-80
ndc (package): 0280-1200-08
ndc (package): 0280-1200-20
ndc (package): 0280-1200-01
ndc (package): 0280-1200-40
ndc (product): 0280-1200
ndc11 (package): 00280120001
ndc11 (package): 00280120005
ndc11 (package): 00280120080
ndc11 (package): 00280120004
ndc11 (package): 00280120002
ndc11 (package): 00280120008
ndc11 (package): 00280120020
ndc11 (package): 00280120003
ndc11 (package): 00280120040
rxcui: 1550963

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
82891458-ab0d-459a-8602-dcebd22c3010Aleve PM 25 MG / 220 MG Oral Tablet [PSN] · diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral Tablet [Aleve PM] [SBD] · Aleve PM (diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG) Oral Tablet [SY]316Aleve ® PM20251204

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
82891458-ab0d-459a-8602-dcebd22c3010Aleve ® PMBayer HealthCare LLC.20251204

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR06AAAminoalkyl ethersATC1-4diphenhydramine
ATCD04AAAntihistamines for topical useATC1-4diphenhydramine
ATCM02AAAntiinflammatory preparations, non-steroids for topical useATC1-4naproxen
ATCG02CCAntiinflammatory products for vaginal administrationATC1-4naproxen
ATCM01AEPropionic acid derivativesATC1-4diphenhydramine / naproxen
ATCM01AEPropionic acid derivativesATC1-4naproxen
FDASPLN0000175587Histamine-1 Receptor AntagonistEPChas_epcdiphenhydramine
FDASPLN0000175722Nonsteroidal Anti-inflammatory DrugEPChas_epcnaproxen
FDASPLN0000000160Cyclooxygenase InhibitorsMOAhas_moanaproxen
FDASPLN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine hydrochloride
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine
MEDRTD009288NaproxenCHEMhas_ingredientnaproxen
MEDRTD009288NaproxenCHEMhas_ingredientnaproxen sodium
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD001171Arthritis, JuvenileDISEASEmay_treatnaproxen
MEDRTD001171Arthritis, JuvenileDISEASEmay_treatnaproxen sodium
MEDRTD001172Arthritis, RheumatoidDISEASEmay_treatnaproxen sodium
MEDRTD001172Arthritis, RheumatoidDISEASEmay_treatnaproxen
MEDRTD001416Back PainDISEASEmay_treatnaproxen sodium
MEDRTD001416Back PainDISEASEmay_treatnaproxen
MEDRTD002062BursitisDISEASEmay_treatnaproxen
MEDRTD002062BursitisDISEASEmay_treatnaproxen sodium
MEDRTD003139Common ColdDISEASEmay_treatnaproxen sodium
MEDRTD003139Common ColdDISEASEmay_treatnaproxen
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withnaproxen sodium
MEDRTD004342Drug HypersensitivityDISEASEci_withnaproxen
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine
MEDRTD004412DysmenorrheaDISEASEmay_treatnaproxen sodium
MEDRTD004412DysmenorrheaDISEASEmay_treatnaproxen
MEDRTD005334FeverDISEASEmay_treatnaproxen sodium
MEDRTD005334FeverDISEASEmay_treatnaproxen
MEDRTD006073GoutDISEASEmay_treatnaproxen sodium
MEDRTD006073GoutDISEASEmay_treatnaproxen
MEDRTD006261HeadacheDISEASEmay_treatnaproxen
MEDRTD006261HeadacheDISEASEmay_treatnaproxen sodium
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine
MEDRTD007249InflammationDISEASEmay_treatnaproxen
MEDRTD007249InflammationDISEASEmay_treatnaproxen sodium
MEDRTD007774LactationDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007774LactationDISEASEci_withdiphenhydramine
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD010003OsteoarthritisDISEASEmay_treatnaproxen sodium
MEDRTD010003OsteoarthritisDISEASEmay_treatnaproxen
MEDRTD010146PainDISEASEmay_preventnaproxen sodium
MEDRTD010146PainDISEASEmay_preventnaproxen
MEDRTD011263Pregnancy Trimester, ThirdDISEASEci_withnaproxen
MEDRTD011263Pregnancy Trimester, ThirdDISEASEci_withnaproxen sodium
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine
MEDRTD013167Spondylitis, AnkylosingDISEASEmay_treatnaproxen
MEDRTD013167Spondylitis, AnkylosingDISEASEmay_treatnaproxen sodium
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine hydrochloride
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine
MEDRTD014098ToothacheDISEASEmay_treatnaproxen
MEDRTD014098ToothacheDISEASEmay_treatnaproxen sodium
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTN0000000160Cyclooxygenase InhibitorsMOAhas_moanaproxen sodium
MEDRTN0000000160Cyclooxygenase InhibitorsMOAhas_moanaproxen
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine hydrochloride
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 sodium
MEDRTN0000009006Decreased Thromboxane ProductionPEhas_penaproxen
MEDRTN0000000042Renal ExcretionPKhas_pknaproxen
MEDRTN0000000042Renal ExcretionPKhas_pknaproxen sodium

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH25 MG / 220 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA205352
NAMESPrescribable SynonymAleve PM 25 MG / 220 MG Oral Tablet
NAMESTallman SynonymAleve PM (diphenhydrAMINE hydrochloride 25 MG / naproxen sodium 220 MG) Oral Tablet
NAMESTallman SynonymdiphenhydrAMINE hydrochloride 25 MG / naproxen sodium 220 MG Oral Tablet [Aleve PM]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon