FDA.reportPublic FDA data

calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Calagesic]

RxCUI
1234539
RxNorm name
calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Calagesic]
Display name
CALAGESIC (Topical)
Full name
calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Calagesic]
Term type
SBD
Status
Active
Strength
8-1%
Dose form
Lotion
Route
Topical
Updated
2026-07-17 22:20:28

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
calamine80 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_STRCalagesic (calamine 8 % / pramoxine hydrochloride 1 % ) Topical LotionNAMES
RxNorm Namecalamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Calagesic]NAMES
RxNorm SynonymCalagesic (calamine 8 % / pramoxine hydrochloride 1 % ) Topical LotionNAMES
TTYSBDATTRIBUTES
SPL_SET_ID8c43590d-56ec-4588-8076-99ba94a16685CODES
SPL_SET_IDe42fb807-8cb4-ed25-e053-2995a90a6780CODES
RxCUI1234539CODES
MMSL_CODEBD6357CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0395-0420-960395-0420Humco Calagesic Calamine and Pramoxine HydrochlorideHumco Holding Group, Inc.M016
82645-922-9682645-922Humco Calagesic Calamine and Pramoxine HydrochloridePharma Nobis, LLCM016

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M0160395-0420Humco Calagesic Calamine and Pramoxine HydrochlorideOTC MONOGRAPH DRUGHumco Holding Group, Inc.

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
00395042096rxnav_ndcsyes
82645092296rxnav_ndcsyes
00395911196rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
8c43590d-56ec-4588-8076-99ba94a16685CALAGESIC 8 % / 1 % Topical LotionPSN6Humco Calagesic Lotion20251211
8c43590d-56ec-4588-8076-99ba94a16685Calagesic (calamine 8 % / pramoxine hydrochloride 1 % ) Topical LotionSY6Humco Calagesic Lotion20251211
8c43590d-56ec-4588-8076-99ba94a16685calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Calagesic]SBD6Humco Calagesic Lotion20251211
60530c40-c34d-5abf-e053-2991aa0a8eafCALAGESIC 8 % / 1 % Topical LotionPSN3Private Label Calagesic Lotion20200619
60530c40-c34d-5abf-e053-2991aa0a8eafcalamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Calagesic]SBD3Private Label Calagesic Lotion20200619
60530c40-c34d-5abf-e053-2991aa0a8eafCalagesic (calamine 8 % / pramoxine hydrochloride 1 % ) Topical LotionSY3Private Label Calagesic Lotion20200619
e42fb807-8cb4-ed25-e053-2995a90a6780calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Calagesic]SBD2Private Label Calagesic Lotion20231226
e42fb807-8cb4-ed25-e053-2995a90a6780Calagesic (calamine 8 % / pramoxine hydrochloride 1 % ) Topical LotionSY2Private Label Calagesic Lotion20231226
e42fb807-8cb4-ed25-e053-2995a90a6780CALAGESIC 8 % / 1 % Topical LotionPSN2Private Label Calagesic Lotion20231226

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
8c43590d-56ec-4588-8076-99ba94a16685Humco Calagesic LotionHumco Holding Group, Inc. | Pharma Nobis, LLC20251211
e42fb807-8cb4-ed25-e053-2995a90a6780Private Label Calagesic LotionPharma Nobis, LLC20231226
60530c40-c34d-5abf-e053-2991aa0a8eafPrivate Label Calagesic LotionHumco Holding Group, Inc.20200619

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_STRENGTH80 MG/ML / 10 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD6357
CODESRxCUI1234539
CODESSPL_SET_ID8c43590d-56ec-4588-8076-99ba94a16685
CODESSPL_SET_IDe42fb807-8cb4-ed25-e053-2995a90a6780
NAMESPrescribable SynonymCALAGESIC 8 % / 1 % Topical Lotion
NAMESRXNAV_STRCalagesic (calamine 8 % / pramoxine hydrochloride 1 % ) Topical Lotion
NAMESRxNorm Namecalamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Calagesic]
NAMESRxNorm SynonymCalagesic (calamine 8 % / pramoxine hydrochloride 1 % ) Topical Lotion
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon