FDA.reportPublic FDA data

diphenhydramine hydrochloride 0.02 MG/MG Topical Gel [Benadryl]

RxCUI
1049882
RxNorm name
diphenhydramine hydrochloride 0.02 MG/MG Topical Gel [Benadryl]
Display name
BENADRYL (Topical)
Full name
diphenhydramine hydrochloride 0.02 MG/MG Topical Gel [Benadryl]
Term type
SBD
Status
Active
Strength
2%
Dose form
Gel
Route
Topical
Updated
2026-07-25 06:53:02

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 hydrochloride0.02 MG / 1 MGdiphenhydraminediphenhydramine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Gel346286

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
diphenhydramine3498

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRBenadryl 0.02 MG/MG Topical GelNAMES
RxNorm Namediphenhydramine hydrochloride 0.02 MG/MG Topical Gel [Benadryl]NAMES
RxNorm SynonymBenadryl 0.02 MG/MG Topical GelNAMES
RxNorm SynonymBenadryl Itch Stop Gel Maximum Strength 0.02 MG/MG Topical GelNAMES
RxNorm SynonymBenadryl Itch Stop Gel Maximum Strength 2 % Topical GelNAMES
TTYSBDATTRIBUTES
SPL_SET_ID66a2fd60-1757-45cc-a195-ecb9241dca2aCODES
RxCUI1049882CODES
MMSL_CODEBD6054CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
69968-0242-369968-0242Benadryl Extra Strength Itch Stopping Diphenhydramine HydrochlorideKenvue Brands LLCM017

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01769968-0242Benadryl Extra Strength Itch Stopping Diphenhydramine HydrochlorideOTC MONOGRAPH DRUGKenvue Brands LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
00501320704rxnav_ndcsyes
12547017157rxnav_ndcsyes
69968024203rxnav_ndcsyes
12547017160rxnav_historical
58232074401rxnav_historical
58232074403rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
66a2fd60-1757-45cc-a195-ecb9241dca2aBenadryl Itch Stop Gel Maximum Strength 0.02 MG/MG Topical GelSY9Benadryl ® EXTRA STRENGTH ITCH STOPPING GEL20250424
66a2fd60-1757-45cc-a195-ecb9241dca2adiphenhydramine hydrochloride 0.02 MG/MG Topical Gel [Benadryl]SBD9Benadryl ® EXTRA STRENGTH ITCH STOPPING GEL20250424
66a2fd60-1757-45cc-a195-ecb9241dca2aBenadryl Itch Stop Gel Maximum Strength 2 % Topical GelPSN9Benadryl ® EXTRA STRENGTH ITCH STOPPING GEL20250424
66a2fd60-1757-45cc-a195-ecb9241dca2aBenadryl Itch Stop Gel Maximum Strength 2 % Topical GelSY9Benadryl ® EXTRA STRENGTH ITCH STOPPING GEL20250424
66a2fd60-1757-45cc-a195-ecb9241dca2aBenadryl 0.02 MG/MG Topical GelSY9Benadryl ® EXTRA STRENGTH ITCH STOPPING GEL20250424

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
66a2fd60-1757-45cc-a195-ecb9241dca2aBenadryl ® EXTRA STRENGTH ITCH STOPPING GELKenvue Brands LLC20250424

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_STRENGTH0.02 MG/MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD6054
CODESRxCUI1049882
CODESSPL_SET_ID66a2fd60-1757-45cc-a195-ecb9241dca2a
NAMESPrescribable SynonymBenadryl Itch Stop Gel Maximum Strength 2 % Topical Gel
NAMESRXNAV_STRBenadryl 0.02 MG/MG Topical Gel
NAMESRxNorm Namediphenhydramine hydrochloride 0.02 MG/MG Topical Gel [Benadryl]
NAMESRxNorm SynonymBenadryl 0.02 MG/MG Topical Gel
NAMESRxNorm SynonymBenadryl Itch Stop Gel Maximum Strength 0.02 MG/MG Topical Gel
NAMESRxNorm SynonymBenadryl Itch Stop Gel Maximum Strength 2 % Topical Gel
NAMESTallman SynonymdiphenhydrAMINE hydrochloride 0.02 MG/MG Topical Gel [Benadryl]
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMultum MediSource Lexicon