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#

RxNav current and historical NDC rows page 1 of 1 · 3 matching rows.

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

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Humco CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDEHumco Holding Group, Inc.8c43590d-56ec-4588-8076-99ba94a166852025-12-11WarningsExact identifier
ndc (package): 0395-0420-96
ndc (product): 0395-0420
ndc11 (package): 00395042096
rxcui: 1234539
Humco CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDEPharma Nobis, LLCe42fb807-8cb4-ed25-e053-2995a90a67802023-12-26WarningsExact identifier
ndc (package): 82645-922-96
ndc (product): 82645-922
ndc11 (package): 82645092296
rxcui: 1234539

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