FDA.reportPublic FDA data

calamine 30 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion

RxCUI
1233698
RxNorm name
calamine 30 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion
Display name
Calamine/Pramoxine (Topical)
Full name
calamine 30 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion
Term type
SCD
Status
Active
Strength
3-1%
Dose form
Lotion
Route
Topical
Updated
2026-07-17 22:19:26

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012012
Active start
012012
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
calamine30 MG / 1 MLcalaminecalamine
pramoxine hydrochloride10 MG / 1 MLpramoxinepramoxine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Lotion316983

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
calamine106212
pramoxine34347

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRcalamine 30 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionNAMES
RxNorm Namecalamine 30 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionNAMES
RxNorm Synonymcalamine 3 % / pramoxine hydrochloride 1 % Topical LotionNAMES
TTYSCDATTRIBUTES
SPL_SET_ID07f4d4d0-9cee-46c3-bc71-2024abd31c9eCODES
RxCUI1233698CODES
MMSL_CODEBD12369CODES
MMSL_CODECD12369CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
69968-0475-469968-0475Aveeno Anti-Itch Concentrated Zinc Oxide, Ferric Oxide Red, and Pramoxine HydrochlorideKenvue Brands LLCM017

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01769968-0475Aveeno Anti-Itch Concentrated Zinc Oxide, Ferric Oxide Red, and Pramoxine HydrochlorideOTC MONOGRAPH DRUGKenvue Brands LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
08137003690rxnav_ndcsyes
69968047504rxnav_ndcsyes
08137003680rxnav_historical_indirect
46500003420rxnav_historical_indirect
58232991002rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
07f4d4d0-9cee-46c3-bc71-2024abd31c9ecalamine 3 % / pramoxine hydrochloride 1 % Topical LotionSY6Aveeno ® Anti-Itch CONCENTRATED LOTION20251029
07f4d4d0-9cee-46c3-bc71-2024abd31c9ecalamine 3 % / pramoxine HCl 1 % Topical LotionPSN6Aveeno ® Anti-Itch CONCENTRATED LOTION20251029
07f4d4d0-9cee-46c3-bc71-2024abd31c9ecalamine 30 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD6Aveeno ® Anti-Itch CONCENTRATED LOTION20251029

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
07f4d4d0-9cee-46c3-bc71-2024abd31c9eAveeno ® Anti-Itch CONCENTRATED LOTIONKenvue Brands LLC20251029
07f4d4d0-9cee-46c3-bc71-2024abd31c9eAveeno ® Anti-Itch CONCENTRATED LOTIONKenvue Brands LLC20241105

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCD04ABAnesthetics for topical useATC1-4pramoxine
ATCC05ADLocal anestheticsATC1-4pramoxine
MEDRTD009025MorpholinesCHEMhas_ingredientpramoxine hydrochloride
MEDRTD009025MorpholinesCHEMhas_ingredientpramoxine
MEDRTD003877Dermatitis, ContactDISEASEmay_treatpramoxine hydrochloride
MEDRTD003877Dermatitis, ContactDISEASEmay_preventcalamine
MEDRTD003877Dermatitis, ContactDISEASEmay_treatpramoxine
MEDRTD004342Drug HypersensitivityDISEASEci_withcalamine
MEDRTD004342Drug HypersensitivityDISEASEci_withpramoxine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withpramoxine
MEDRTD005401Fissure in AnoDISEASEmay_treatpramoxine
MEDRTD005401Fissure in AnoDISEASEmay_treatpramoxine hydrochloride
MEDRTD006484HemorrhoidsDISEASEmay_treatpramoxine
MEDRTD006484HemorrhoidsDISEASEmay_treatpramoxine hydrochloride
MEDRTD010146PainDISEASEmay_treatpramoxine
MEDRTD010146PainDISEASEmay_treatpramoxine hydrochloride
MEDRTD010939Plant PoisoningDISEASEmay_preventcalamine
MEDRTD011537PruritusDISEASEmay_treatpramoxine hydrochloride
MEDRTD011537PruritusDISEASEmay_treatpramoxine
MEDRTN0000009915Unknown Cellular or Molecular InteractionMOAhas_moapramoxine
MEDRTN0000009915Unknown Cellular or Molecular InteractionMOAhas_moacalamine
MEDRTN0000009915Unknown Cellular or Molecular InteractionMOAhas_moapramoxine hydrochloride
MEDRTN0000008301Astringent ActivityPEhas_pecalamine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pepramoxine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pepramoxine hydrochloride
MEDRTN0000010282Skin Barrier ActivityPEhas_pecalamine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH30 MG/ML / 10 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD12369
CODESMMSL_CODECD12369
CODESRxCUI1233698
CODESSPL_SET_ID07f4d4d0-9cee-46c3-bc71-2024abd31c9e
NAMESPrescribable Synonymcalamine 3 % / pramoxine HCl 1 % Topical Lotion
NAMESRXNAV_STRcalamine 30 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion
NAMESRxNorm Namecalamine 30 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion
NAMESRxNorm Synonymcalamine 3 % / pramoxine hydrochloride 1 % Topical Lotion
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary