FDA.reportPublic FDA data

diphenhydramine hydrochloride 0.02 MG/MG / levomenthol 0.01 MG/MG Topical Gel [Tact]

RxCUI
1235322
RxNorm name
diphenhydramine hydrochloride 0.02 MG/MG / levomenthol 0.01 MG/MG Topical Gel [Tact]
Term type
SBD
Status
Active
Updated
2026-07-25 06:55:06

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012012
Active start
012012
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
levomenthol0.01 MG / 1 MGlevomenthollevomenthol
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
levomenthol236388
diphenhydramine3498

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
RXNAV_STRTact (diphenhydrAMINE HCl 2 % / l-menthol 1 % ) Topical GelNAMES
RxNorm Namediphenhydramine hydrochloride 0.02 MG/MG / levomenthol 0.01 MG/MG Topical Gel [Tact]NAMES
RxNorm SynonymTact (diphenhydramine HCl 2 % / l-menthol 1 % ) Topical GelNAMES
TTYSBDATTRIBUTES
SPL_SET_IDf34872c9-91b9-49db-8e41-5b54a069284aCODES
RxCUI1235322CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
49873-704-0149873-704Tact Cool diphenhydramine hydrochloride, levomentholSato Pharmaceutical Co., Ltd.M017

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01749873-704Tact Cool diphenhydramine hydrochloride, levomentholOTC MONOGRAPH DRUGSato Pharmaceutical Co., Ltd.

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
49873070401rxnav_ndcsyes

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
f34872c9-91b9-49db-8e41-5b54a069284aTact Cool Jelly 2 % / 1 % Topical GelPSN7Tact Cool Jelly20231201
f34872c9-91b9-49db-8e41-5b54a069284aTact (diphenhydramine HCl 2 % / l-menthol 1 % ) Topical GelSY7Tact Cool Jelly20231201
f34872c9-91b9-49db-8e41-5b54a069284adiphenhydramine hydrochloride 0.02 MG/MG / levomenthol 0.01 MG/MG Topical Gel [Tact]SBD7Tact Cool Jelly20231201

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
f34872c9-91b9-49db-8e41-5b54a069284aTact Cool JellySato Pharmaceutical Co., Ltd.20231201

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 (expressed as diphenhydramine hydrochloride) / 0.01 MG/MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESTTYSBD
CODESRxCUI1235322
CODESSPL_SET_IDf34872c9-91b9-49db-8e41-5b54a069284a
NAMESPrescribable SynonymTact Cool Jelly 2 % / 1 % Topical Gel
NAMESRXNAV_STRTact (diphenhydrAMINE HCl 2 % / l-menthol 1 % ) Topical Gel
NAMESRxNorm Namediphenhydramine hydrochloride 0.02 MG/MG / levomenthol 0.01 MG/MG Topical Gel [Tact]
NAMESRxNorm SynonymTact (diphenhydramine HCl 2 % / l-menthol 1 % ) Topical Gel
NAMESTallman SynonymdiphenhydrAMINE hydrochloride 0.02 MG/MG / levomenthol 0.01 MG/MG Topical Gel [Tact]
NAMESTallman SynonymTact (diphenhydrAMINE HCl 2 % / l-menthol 1 % ) Topical Gel
SOURCESSourceMetathesaurus FDA Structured Product Labels