FDA.reportPublic FDA data

diphenhydramine hydrochloride 20 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion

RxCUI
1292321
RxNorm name
diphenhydramine hydrochloride 20 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion
Display name
diphenhydrAMINE/Pramoxine (Topical)
Full name
diphenhydramine hydrochloride 20 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion
Term type
SCD
Status
Active
Strength
2-1%
Dose form
Lotion
Route
Topical
Updated
2026-07-19 06:54:36

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
062012
Active start
062012
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
pramoxine hydrochloride10 MG / 1 MLpramoxinepramoxine hydrochloride
diphenhydramine hydrochloride20 MG / 1 MLdiphenhydraminediphenhydramine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Lotion316983

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
pramoxine34347
diphenhydramine3498

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRdiphenhydrAMINE hydrochloride 20 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionNAMES
RxNorm Namediphenhydramine hydrochloride 20 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionNAMES
RxNorm Synonymdiphenhydramine hydrochloride 2 % / pramoxine hydrochloride 1 % Topical LotionNAMES
TTYSCDATTRIBUTES
SPL_SET_ID0a4d471b-c3f3-0a6a-e063-6394a90ad57bCODES
RxCUI1292321CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
11383-192-0111383-192Bite and Itch Diphenhydramine Hydrochloride, Pramoxine HydrochlorideWeeks & Leo Co., Inc.M017
11383-192-0411383-192Bite and Itch Diphenhydramine Hydrochloride, Pramoxine HydrochlorideWeeks & Leo Co., Inc.M017

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01711383-192Bite and Itch Diphenhydramine Hydrochloride, Pramoxine HydrochlorideOTC MONOGRAPH DRUGWeeks & Leo Co., Inc.

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
10956074204rxnav_ndcsyes
11383019201rxnav_ndcsyes
11383019204rxnav_ndcsyes
11383019304rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
0a4d471b-c3f3-0a6a-e063-6394a90ad57bdiphenhydramine hydrochloride 2 % / pramoxine hydrochloride 1 % Topical LotionSY3Bite and Itch Lotion20241203
0a4d471b-c3f3-0a6a-e063-6394a90ad57bdiphenhydrAMINE HCl 2 % / pramoxine HCl 1 % Topical LotionPSN3Bite and Itch Lotion20241203
0a4d471b-c3f3-0a6a-e063-6394a90ad57bdiphenhydramine hydrochloride 20 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD3Bite and Itch Lotion20241203

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
0a4d471b-c3f3-0a6a-e063-6394a90ad57bBite and Itch LotionWeeks & Leo Co., Inc.20241203

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR06AAAminoalkyl ethersATC1-4diphenhydramine
ATCD04ABAnesthetics for topical useATC1-4pramoxine
ATCD04AAAntihistamines for topical useATC1-4diphenhydramine
ATCC05ADLocal anestheticsATC1-4pramoxine
FDASPLN0000175587Histamine-1 Receptor AntagonistEPChas_epcdiphenhydramine
FDASPLN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine hydrochloride
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine
MEDRTD009025MorpholinesCHEMhas_ingredientpramoxine hydrochloride
MEDRTD009025MorpholinesCHEMhas_ingredientpramoxine
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD003877Dermatitis, ContactDISEASEmay_treatpramoxine
MEDRTD003877Dermatitis, ContactDISEASEmay_treatpramoxine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withpramoxine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withpramoxine
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine
MEDRTD005401Fissure in AnoDISEASEmay_treatpramoxine
MEDRTD005401Fissure in AnoDISEASEmay_treatpramoxine hydrochloride
MEDRTD006484HemorrhoidsDISEASEmay_treatpramoxine
MEDRTD006484HemorrhoidsDISEASEmay_treatpramoxine hydrochloride
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine
MEDRTD007774LactationDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007774LactationDISEASEci_withdiphenhydramine
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine
MEDRTD010146PainDISEASEmay_treatpramoxine
MEDRTD010146PainDISEASEmay_treatpramoxine hydrochloride
MEDRTD011537PruritusDISEASEmay_treatpramoxine
MEDRTD011537PruritusDISEASEmay_treatpramoxine hydrochloride
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine hydrochloride
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine hydrochloride
MEDRTN0000009915Unknown Cellular or Molecular InteractionMOAhas_moapramoxine
MEDRTN0000009915Unknown Cellular or Molecular InteractionMOAhas_moapramoxine hydrochloride
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pepramoxine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pepramoxine hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH20 MG/ML / 10 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESTTYSCD
CODESRxCUI1292321
CODESSPL_SET_ID0a4d471b-c3f3-0a6a-e063-6394a90ad57b
NAMESPrescribable SynonymdiphenhydrAMINE HCl 2 % / pramoxine HCl 1 % Topical Lotion
NAMESRXNAV_STRdiphenhydrAMINE hydrochloride 20 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion
NAMESRxNorm Namediphenhydramine hydrochloride 20 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion
NAMESRxNorm Synonymdiphenhydramine hydrochloride 2 % / pramoxine hydrochloride 1 % Topical Lotion
NAMESTallman SynonymdiphenhydrAMINE hydrochloride 2 % / pramoxine hydrochloride 1 % Topical Lotion
NAMESTallman SynonymdiphenhydrAMINE hydrochloride 20 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceNational Drug Data File Plus Source Vocabulary