FDA.reportPublic FDA data

diphenhydramine hydrochloride 50 MG Oral Capsule [Benadryl]

RxCUI
1050076
RxNorm name
diphenhydramine hydrochloride 50 MG Oral Capsule [Benadryl]
Display name
BENADRYL (Oral Pill)
Full name
diphenhydramine hydrochloride 50 MG Oral Capsule [Benadryl]
Term type
SBD
Status
Active
Strength
50 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-07-22 07:06:23

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012011
Active start
012011
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
diphenhydramine hydrochloride50 MG / 1 EACHdiphenhydraminediphenhydramine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Capsule316965

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
diphenhydramine3498

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRBenadryl 50 MG Oral CapsuleNAMES
RxNorm Namediphenhydramine hydrochloride 50 MG Oral Capsule [Benadryl]NAMES
RxNorm SynonymBenadryl 50 MG Oral CapsuleNAMES
TTYSBDATTRIBUTES
SPL_SET_ID30aca3ab-b091-3939-e063-6294a90a9819CODES
RxCUI1050076CODES
MMSL_CODEBD3406CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
50580-322-2050580-322Benadryl Allergy Extra Strength Liqui-Gels Diphenhydramine HydrochlorideKenvue Brands LLCM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01250580-322Benadryl Allergy Extra Strength Liqui-Gels Diphenhydramine HydrochlorideOTC MONOGRAPH DRUGKenvue Brands LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
50580032220rxnav_ndcsyes
00071037324rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
30aca3ab-b091-3939-e063-6294a90a9819Benadryl Allergy 50 MG Oral CapsulePSN3Benadryl Allergy Extra Strength Liqui-Gels20251203
30aca3ab-b091-3939-e063-6294a90a9819Benadryl 50 MG Oral CapsuleSY3Benadryl Allergy Extra Strength Liqui-Gels20251203
30aca3ab-b091-3939-e063-6294a90a9819diphenhydramine hydrochloride 50 MG Oral Capsule [Benadryl]SBD3Benadryl Allergy Extra Strength Liqui-Gels20251203

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
30aca3ab-b091-3939-e063-6294a90a9819Benadryl Allergy Extra Strength Liqui-GelsKenvue Brands LLC20251203

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR06AAAminoalkyl ethersATC1-4diphenhydramine
ATCD04AAAntihistamines for topical useATC1-4diphenhydramine
FDASPLN0000175587Histamine-1 Receptor AntagonistEPChas_epcdiphenhydramine
FDASPLN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine hydrochloride
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine
MEDRTD007774LactationDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007774LactationDISEASEci_withdiphenhydramine
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine hydrochloride
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESACTIVATED07/01/2025
ATTRIBUTESAVAILABLE_STRENGTH50 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD3406
CODESRxCUI1050076
CODESSPL_SET_ID30aca3ab-b091-3939-e063-6294a90a9819
NAMESPrescribable SynonymBenadryl Allergy 50 MG Oral Capsule
NAMESRXNAV_STRBenadryl 50 MG Oral Capsule
NAMESRxNorm Namediphenhydramine hydrochloride 50 MG Oral Capsule [Benadryl]
NAMESRxNorm SynonymBenadryl 50 MG Oral Capsule
NAMESTallman SynonymdiphenhydrAMINE hydrochloride 50 MG Oral Capsule [Benadryl]
SOURCESSourceMetathesaurus FDA Structured Product Labels