FDA.reportPublic FDA data

diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Benadryl]

RxCUI
1049908
RxNorm name
diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Benadryl]
Display name
BENADRYL (Oral Liquid)
Full name
diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Benadryl]
Term type
SBD
Status
Active
Strength
12.5 mg/5ml
Dose form
Sol
Route
Oral Liquid
Updated
2026-07-25 06:53:11

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 hydrochloride2.5 MG / 1 MLdiphenhydraminediphenhydramine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Solution316968

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
diphenhydramine3498

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRBenadryl 2.5 MG/ML Oral SolutionNAMES
RxNorm Namediphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Benadryl]NAMES
RxNorm SynonymBenadryl 2.5 MG/ML Oral SolutionNAMES
RxNorm SynonymBenadryl Children's Allergy 12.5 MG per 5 ML Oral SolutionNAMES
TTYSBDATTRIBUTES
SPL_SET_ID10d478ff-ddc6-45da-87ff-cfe1b2b07a8eCODES
SPL_SET_ID224ba2a3-1a93-29c8-e063-6394a90a9befCODES
SPL_SET_IDfc9181b9-c92d-493e-8d7c-4a4239c6c092CODES
RxCUI1049908CODES
MMSL_CODEBD3420CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
50580-534-0450580-534Childrens Benadryl ALLERGY Diphenhydramine hydrochlorideKenvue Brands LLCM012
50580-534-0850580-534Childrens Benadryl ALLERGY Diphenhydramine hydrochlorideKenvue Brands LLCM012
50580-534-1850580-534Childrens Benadryl ALLERGY Diphenhydramine hydrochlorideKenvue Brands LLCM012
50580-535-0150580-535Childrens Benadryl DYE-FREE ALLERGY Diphenhydramine hydrochlorideKenvue Brands LLCM012
50580-535-0250580-535Childrens Benadryl DYE-FREE ALLERGY Diphenhydramine hydrochlorideKenvue Brands LLCM012
50580-535-0850580-535Childrens Benadryl DYE-FREE ALLERGY Diphenhydramine hydrochlorideKenvue Brands LLCM012
50580-573-0450580-573BENADRYL Allergy Diphenhydramine hydrochlorideKenvue Brands LLCM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01250580-534Childrens Benadryl ALLERGY Diphenhydramine hydrochlorideOTC MONOGRAPH DRUGKenvue Brands LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
50580053404rxnav_ndcsyes
50580053408rxnav_ndcsyes
50580053416rxnav_ndcsyes
50580053418rxnav_ndcsyes
50580053501rxnav_ndcsyes
50580053502rxnav_ndcsyes
50580053504rxnav_ndcsyes
50580053508rxnav_ndcsyes
50580057304rxnav_ndcsyes
00045053402rxnav_historical
00071233317rxnav_historical
00501204910rxnav_historical
00501205004rxnav_historical
00501205008rxnav_historical
00501205304rxnav_historical
12547017055rxnav_historical
12547017137rxnav_historical
12547017540rxnav_historical
21695057404rxnav_historical
35058053501rxnav_historical
50580033410rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
fc9181b9-c92d-493e-8d7c-4a4239c6c092diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Benadryl]SBD13Children's Benadryl ® ALLERGY20250513
fc9181b9-c92d-493e-8d7c-4a4239c6c092Benadryl Children's Allergy 12.5 MG in 5 mL Oral SolutionPSN13Children's Benadryl ® ALLERGY20250513
fc9181b9-c92d-493e-8d7c-4a4239c6c092Benadryl Children's Allergy 12.5 MG per 5 ML Oral SolutionSY13Children's Benadryl ® ALLERGY20250513
fc9181b9-c92d-493e-8d7c-4a4239c6c092Benadryl 2.5 MG/ML Oral SolutionSY13Children's Benadryl ® ALLERGY20250513
10d478ff-ddc6-45da-87ff-cfe1b2b07a8eBenadryl Children's Allergy 12.5 MG in 5 mL Oral SolutionPSN10Children's Benadryl ® DYE-FREE ALLERGY20241127
10d478ff-ddc6-45da-87ff-cfe1b2b07a8eBenadryl 2.5 MG/ML Oral SolutionSY10Children's Benadryl ® DYE-FREE ALLERGY20241127
10d478ff-ddc6-45da-87ff-cfe1b2b07a8ediphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Benadryl]SBD10Children's Benadryl ® DYE-FREE ALLERGY20241127
10d478ff-ddc6-45da-87ff-cfe1b2b07a8eBenadryl Children's Allergy 12.5 MG per 5 ML Oral SolutionSY10Children's Benadryl ® DYE-FREE ALLERGY20241127
224ba2a3-1a93-29c8-e063-6394a90a9befBenadryl 2.5 MG/ML Oral SolutionSY3BENADRYL Allergy Oral Solution20250130
224ba2a3-1a93-29c8-e063-6394a90a9befBenadryl Children's Allergy 12.5 MG in 5 mL Oral SolutionPSN3BENADRYL Allergy Oral Solution20250130
224ba2a3-1a93-29c8-e063-6394a90a9befBenadryl Children's Allergy 12.5 MG per 5 ML Oral SolutionSY3BENADRYL Allergy Oral Solution20250130
224ba2a3-1a93-29c8-e063-6394a90a9befdiphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Benadryl]SBD3BENADRYL Allergy Oral Solution20250130

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
fc9181b9-c92d-493e-8d7c-4a4239c6c092Children's Benadryl ® ALLERGYKenvue Brands LLC20250513
224ba2a3-1a93-29c8-e063-6394a90a9befBENADRYL Allergy Oral SolutionKenvue Brands LLC20250130
10d478ff-ddc6-45da-87ff-cfe1b2b07a8eChildren's Benadryl ® DYE-FREE ALLERGYKenvue Brands LLC20241127

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_STRENGTH2.5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD3420
CODESRxCUI1049908
CODESSPL_SET_ID10d478ff-ddc6-45da-87ff-cfe1b2b07a8e
CODESSPL_SET_ID224ba2a3-1a93-29c8-e063-6394a90a9bef
CODESSPL_SET_IDfc9181b9-c92d-493e-8d7c-4a4239c6c092
NAMESPrescribable SynonymBenadryl Children's Allergy 12.5 MG in 5 mL Oral Solution
NAMESRXNAV_STRBenadryl 2.5 MG/ML Oral Solution
NAMESRxNorm Namediphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Benadryl]
NAMESRxNorm SynonymBenadryl 2.5 MG/ML Oral Solution
NAMESRxNorm SynonymBenadryl Children's Allergy 12.5 MG per 5 ML Oral Solution
NAMESTallman SynonymdiphenhydrAMINE hydrochloride 2.5 MG/ML Oral Solution [Benadryl]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon