FDA.reportPublic FDA data

diphenhydramine hydrochloride 12.5 MG Chewable Tablet [Benadryl]

RxCUI
1049901
RxNorm name
diphenhydramine hydrochloride 12.5 MG Chewable Tablet [Benadryl]
Display name
BENADRYL (Chewable)
Full name
diphenhydramine hydrochloride 12.5 MG Chewable Tablet [Benadryl]
Term type
SBD
Status
Active
Strength
12.5 mg
Dose form
Tab
Route
Chewable
Updated
2026-07-25 06:53:05

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 hydrochloride12.5 MG / 1 EACHdiphenhydraminediphenhydramine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Chewable Tablet91058

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
diphenhydramine3498

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRBenadryl 12.5 MG Chewable TabletNAMES
RxNorm Namediphenhydramine hydrochloride 12.5 MG Chewable Tablet [Benadryl]NAMES
RxNorm SynonymBenadryl 12.5 MG Chewable TabletNAMES
TTYSBDATTRIBUTES
SPL_SET_IDb08f71d8-a06c-41ba-8ed1-fbc41dbc1919CODES
RxCUI1049901CODES
MMSL_CODEBD6055CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
50580-232-0150580-232Childrens Benadryl Chewables diphenhydramine hydrochlorideKenvue Brands LLCM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01250580-232Childrens Benadryl Chewables diphenhydramine hydrochlorideOTC MONOGRAPH DRUGKenvue Brands LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
50580023201rxnav_ndcsyes
00045055320rxnav_historical
00501201024rxnav_historical
12547017238rxnav_historical
50580034718rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
b08f71d8-a06c-41ba-8ed1-fbc41dbc1919Benadryl 12.5 MG Chewable TabletSY7Children's Benadryl ® Chewables20241108
b08f71d8-a06c-41ba-8ed1-fbc41dbc1919diphenhydramine hydrochloride 12.5 MG Chewable Tablet [Benadryl]SBD7Children's Benadryl ® Chewables20241108
b08f71d8-a06c-41ba-8ed1-fbc41dbc1919Benadryl Allergy 12.5 MG Chewable TabletPSN7Children's Benadryl ® Chewables20241108

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
b08f71d8-a06c-41ba-8ed1-fbc41dbc1919Children's Benadryl ® ChewablesKenvue Brands LLC20241108

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
ATTRIBUTESAVAILABLE_STRENGTH12.5 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD6055
CODESRxCUI1049901
CODESSPL_SET_IDb08f71d8-a06c-41ba-8ed1-fbc41dbc1919
NAMESPrescribable SynonymBenadryl Allergy 12.5 MG Chewable Tablet
NAMESRXNAV_STRBenadryl 12.5 MG Chewable Tablet
NAMESRxNorm Namediphenhydramine hydrochloride 12.5 MG Chewable Tablet [Benadryl]
NAMESRxNorm SynonymBenadryl 12.5 MG Chewable Tablet
NAMESTallman SynonymdiphenhydrAMINE hydrochloride 12.5 MG Chewable Tablet [Benadryl]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon