FDA.reportPublic FDA data

hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream

RxCUI
1235049
RxNorm name
hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream
Display name
Hydrocortisone/Pramoxine (Rectal)
Full name
hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream
Term type
SCD
Status
Active
Strength
1-1%
Dose form
Cream
Route
Rectal
Updated
2026-07-18 07:00:58

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012012
Active start
062012
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
pramoxine hydrochloride10 MG / 1 MLpramoxinepramoxine hydrochloride
hydrocortisone acetate10 MG / 1 MLhydrocortisonehydrocortisone acetate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Rectal Cream316975

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
pramoxine34347
hydrocortisone5492

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRhydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamNAMES
RxNorm Namehydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamNAMES
RxNorm Synonymhydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal CreamNAMES
TTYSCDATTRIBUTES
SPL_SET_ID0c28458a-cc56-4eea-89aa-d60659bd9568CODES
SPL_SET_ID3c5e1833-9908-4e4f-bdf2-7a28c14a585cCODES
SPL_SET_ID9eea5875-d153-4bba-aee2-b1d1cd8b5e57CODES
RxCUI1235049CODES
MMSL_CODEBD1701CODES
MMSL_CODEBD6841CODES
MMSL_CODECD6841CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
45802-144-6445802-144hydrocortisone acetate pramoxine hcl hydrocortisone acetate pramoxine hclPadagis Israel Pharmaceuticals LtdANDA085368
63629-8669-163629-8669hydrocortisone acetate pramoxine hcl hydrocortisone acetate pramoxine hclBryant Ranch PrepackANDA085368
72162-1399-372162-1399hydrocortisone acetate pramoxine hcl hydrocortisone acetate pramoxine hclBryant Ranch PrepackANDA085368

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA08536845802-144hydrocortisone acetate pramoxine hcl hydrocortisone acetate pramoxine hclANDAPadagis Israel Pharmaceuticals Ltd

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
45802014464rxnav_ndcsyes
63629866901rxnav_ndcsyes
72162139903rxnav_ndcsyes
00021462010rxnav_historical_indirect
00021462036rxnav_historical_indirect
42192010901rxnav_historical
49769042501rxnav_historical
51991001321rxnav_historical
52316015630rxnav_historical_indirect
52959050001rxnav_historical_indirect
53002084466rxnav_historical_indirect
68032042501rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
3c5e1833-9908-4e4f-bdf2-7a28c14a585chydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal CreamPSN104Hydrocortisone Acetate 1% Pramoxine HCl 1% Cream20230718
3c5e1833-9908-4e4f-bdf2-7a28c14a585chydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD104Hydrocortisone Acetate 1% Pramoxine HCl 1% Cream20230718
3c5e1833-9908-4e4f-bdf2-7a28c14a585chydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal CreamSY104Hydrocortisone Acetate 1% Pramoxine HCl 1% Cream20230718
0c28458a-cc56-4eea-89aa-d60659bd9568hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD100Hydrocortisone Acetate 1% Pramoxine HCl 1% Cream20230817
0c28458a-cc56-4eea-89aa-d60659bd9568hydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal CreamPSN100Hydrocortisone Acetate 1% Pramoxine HCl 1% Cream20230817
0c28458a-cc56-4eea-89aa-d60659bd9568hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal CreamSY100Hydrocortisone Acetate 1% Pramoxine HCl 1% Cream20230817
9eea5875-d153-4bba-aee2-b1d1cd8b5e57hydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal CreamPSN5Hydrocortisone Acetate 1% Pramoxine HCl 1% Cream20220531
9eea5875-d153-4bba-aee2-b1d1cd8b5e57hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal CreamSY5Hydrocortisone Acetate 1% Pramoxine HCl 1% Cream20220531
9eea5875-d153-4bba-aee2-b1d1cd8b5e57hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD5Hydrocortisone Acetate 1% Pramoxine HCl 1% Cream20220531
27b3c751-d972-4cb9-9235-55e29953bf8dhydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal CreamSY4Analpram HC ® (hydrocortisone acetate 1% pramoxine HCl 1%) Cream 1%20251108
27b3c751-d972-4cb9-9235-55e29953bf8dhydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD4Analpram HC ® (hydrocortisone acetate 1% pramoxine HCl 1%) Cream 1%20251108
27b3c751-d972-4cb9-9235-55e29953bf8dhydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal CreamPSN4Analpram HC ® (hydrocortisone acetate 1% pramoxine HCl 1%) Cream 1%20251108
39618fc5-87a8-47bc-93fc-cb97b8f663c8hydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal CreamPSN1Analpram HC ® (hydrocortisone acetate 1% pramoxine HCl 1%) Cream 1%20250624
39618fc5-87a8-47bc-93fc-cb97b8f663c8hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal CreamSY1Analpram HC ® (hydrocortisone acetate 1% pramoxine HCl 1%) Cream 1%20250624
39618fc5-87a8-47bc-93fc-cb97b8f663c8hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD1Analpram HC ® (hydrocortisone acetate 1% pramoxine HCl 1%) Cream 1%20250624

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
0c28458a-cc56-4eea-89aa-d60659bd9568Hydrocortisone Acetate 1% Pramoxine HCl 1% CreamBryant Ranch Prepack20230817
3c5e1833-9908-4e4f-bdf2-7a28c14a585cHydrocortisone Acetate 1% Pramoxine HCl 1% CreamBryant Ranch Prepack20230718
9eea5875-d153-4bba-aee2-b1d1cd8b5e57Hydrocortisone Acetate 1% Pramoxine HCl 1% CreamPadagis Israel Pharmaceuticals Ltd20220531

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCD04ABAnesthetics for topical useATC1-4pramoxine
ATCC05AACorticosteroidsATC1-4hydrocortisone
ATCS02BACorticosteroidsATC1-4hydrocortisone
ATCA07EACorticosteroids acting locallyATC1-4hydrocortisone
ATCA01ACCorticosteroids for local oral treatmentATC1-4hydrocortisone
ATCS01BACorticosteroids, plainATC1-4hydrocortisone
ATCD07AACorticosteroids, weak (group I)ATC1-4hydrocortisone
ATCD07XACorticosteroids, weak, other combinationsATC1-4hydrocortisone
ATCS01CBCorticosteroids/antiinfectives/mydriatics in combinationATC1-4hydrocortisone
ATCH02ABGlucocorticoidsATC1-4hydrocortisone
ATCC05ADLocal anestheticsATC1-4pramoxine
FDASPLN0000175576CorticosteroidEPChas_epchydrocortisone
MEDRTD006854HydrocortisoneCHEMhas_ingredienthydrocortisone
MEDRTD006854HydrocortisoneCHEMhas_ingredienthydrocortisone acetate
MEDRTD009025MorpholinesCHEMhas_ingredientpramoxine
MEDRTD009025MorpholinesCHEMhas_ingredientpramoxine hydrochloride
MEDRTD000312Adrenal Hyperplasia, CongenitalDISEASEmay_treathydrocortisone acetate
MEDRTD000312Adrenal Hyperplasia, CongenitalDISEASEmay_treathydrocortisone
MEDRTD000309Adrenal InsufficiencyDISEASEmay_treathydrocortisone acetate
MEDRTD000309Adrenal InsufficiencyDISEASEmay_treathydrocortisone
MEDRTD003093Colitis, UlcerativeDISEASEmay_treathydrocortisone acetate
MEDRTD003093Colitis, UlcerativeDISEASEmay_treathydrocortisone
MEDRTD003877Dermatitis, ContactDISEASEmay_treatpramoxine
MEDRTD003877Dermatitis, ContactDISEASEmay_treathydrocortisone acetate
MEDRTD003877Dermatitis, ContactDISEASEmay_treathydrocortisone
MEDRTD003877Dermatitis, ContactDISEASEmay_treatpramoxine hydrochloride
MEDRTD003881DermatomycosesDISEASEci_withhydrocortisone
MEDRTD003881DermatomycosesDISEASEci_withhydrocortisone acetate
MEDRTD004342Drug HypersensitivityDISEASEci_withhydrocortisone
MEDRTD004342Drug HypersensitivityDISEASEci_withhydrocortisone acetate
MEDRTD004342Drug HypersensitivityDISEASEci_withpramoxine
MEDRTD004342Drug HypersensitivityDISEASEci_withpramoxine hydrochloride
MEDRTD005148Facial DermatosesDISEASEmay_treathydrocortisone
MEDRTD005148Facial DermatosesDISEASEmay_treathydrocortisone acetate
MEDRTD005401Fissure in AnoDISEASEmay_treatpramoxine
MEDRTD005401Fissure in AnoDISEASEmay_treatpramoxine hydrochloride
MEDRTD005533Foot DermatosesDISEASEmay_treathydrocortisone
MEDRTD005533Foot DermatosesDISEASEmay_treathydrocortisone acetate
MEDRTD006229Hand DermatosesDISEASEmay_treathydrocortisone
MEDRTD006229Hand DermatosesDISEASEmay_treathydrocortisone acetate
MEDRTD006484HemorrhoidsDISEASEmay_treathydrocortisone
MEDRTD006484HemorrhoidsDISEASEmay_treathydrocortisone acetate
MEDRTD006484HemorrhoidsDISEASEmay_treatpramoxine
MEDRTD006484HemorrhoidsDISEASEmay_treatpramoxine hydrochloride
MEDRTD007249InflammationDISEASEmay_treathydrocortisone acetate
MEDRTD007249InflammationDISEASEmay_treathydrocortisone
MEDRTD007868Leg DermatosesDISEASEmay_treathydrocortisone
MEDRTD007868Leg DermatosesDISEASEmay_treathydrocortisone acetate
MEDRTD010146PainDISEASEmay_treatpramoxine
MEDRTD010146PainDISEASEmay_treatpramoxine hydrochloride
MEDRTD011537PruritusDISEASEmay_treatpramoxine hydrochloride
MEDRTD011537PruritusDISEASEmay_treatpramoxine
MEDRTD011538Pruritus AniDISEASEmay_treathydrocortisone acetate
MEDRTD011538Pruritus AniDISEASEmay_treathydrocortisone
MEDRTD012216Rheumatic DiseasesDISEASEmay_treathydrocortisone acetate
MEDRTD012216Rheumatic DiseasesDISEASEmay_treathydrocortisone
MEDRTD012536Scalp DermatosesDISEASEmay_treathydrocortisone acetate
MEDRTD012536Scalp DermatosesDISEASEmay_treathydrocortisone
MEDRTD012769ShockDISEASEmay_treathydrocortisone acetate
MEDRTD012769ShockDISEASEmay_treathydrocortisone
MEDRTD012876Skin Diseases, ParasiticDISEASEci_withhydrocortisone
MEDRTD012876Skin Diseases, ParasiticDISEASEci_withhydrocortisone acetate
MEDRTD017193Skin Diseases, ViralDISEASEci_withhydrocortisone
MEDRTD017193Skin Diseases, ViralDISEASEci_withhydrocortisone acetate
MEDRTD013224Status AsthmaticusDISEASEmay_treathydrocortisone
MEDRTD013224Status AsthmaticusDISEASEmay_treathydrocortisone acetate
MEDRTD014382Tuberculosis, CutaneousDISEASEci_withhydrocortisone acetate
MEDRTD014382Tuberculosis, CutaneousDISEASEci_withhydrocortisone
MEDRTN0000000159Glucocorticoid Receptor AgonistsMOAhas_moahydrocortisone acetate
MEDRTN0000000159Glucocorticoid Receptor AgonistsMOAhas_moahydrocortisone
MEDRTN0000000134Lipoxygenase InhibitorsMOAhas_moahydrocortisone acetate
MEDRTN0000000134Lipoxygenase InhibitorsMOAhas_moahydrocortisone
MEDRTN0000009915Unknown Cellular or Molecular InteractionMOAhas_moapramoxine
MEDRTN0000009915Unknown Cellular or Molecular InteractionMOAhas_moapramoxine hydrochloride
MEDRTN0000008327Carbohydrate Metabolism AlterationPEhas_pehydrocortisone acetate
MEDRTN0000008327Carbohydrate Metabolism AlterationPEhas_pehydrocortisone
MEDRTN0000010253Decreased Capillary PermeabilityPEhas_pehydrocortisone acetate
MEDRTN0000010253Decreased Capillary PermeabilityPEhas_pehydrocortisone
MEDRTN0000010248Decreased Fibroblast MigrationPEhas_pehydrocortisone
MEDRTN0000010248Decreased Fibroblast MigrationPEhas_pehydrocortisone acetate
MEDRTN0000008645Decreased Glucocorticoid SecretionPEhas_pehydrocortisone
MEDRTN0000008645Decreased Glucocorticoid SecretionPEhas_pehydrocortisone acetate
MEDRTN0000008681Decreased Leukotriene ActivityPEhas_pehydrocortisone
MEDRTN0000008681Decreased Leukotriene ActivityPEhas_pehydrocortisone acetate
MEDRTN0000008700Decreased Lysosomal FunctionPEhas_pehydrocortisone
MEDRTN0000008700Decreased Lysosomal FunctionPEhas_pehydrocortisone acetate
MEDRTN0000010246Decreased Polymorphonuclear Leukocyte MigrationPEhas_pehydrocortisone acetate
MEDRTN0000010246Decreased Polymorphonuclear Leukocyte MigrationPEhas_pehydrocortisone
MEDRTN0000008834Decreased Prostaglandin ActivityPEhas_pehydrocortisone acetate
MEDRTN0000008834Decreased Prostaglandin ActivityPEhas_pehydrocortisone
MEDRTN0000008841Decreased Protein SynthesisPEhas_pehydrocortisone acetate
MEDRTN0000008841Decreased Protein SynthesisPEhas_pehydrocortisone
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pepramoxine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pepramoxine hydrochloride
MEDRTN0000009004Decreased Thromboxane ActivityPEhas_pehydrocortisone acetate
MEDRTN0000009004Decreased Thromboxane ActivityPEhas_pehydrocortisone
MEDRTN0000009739Lipid Metabolism AlterationPEhas_pehydrocortisone acetate
MEDRTN0000009739Lipid Metabolism AlterationPEhas_pehydrocortisone

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH10 MG/ML (expressed as hydrocortisone acetate) / 10 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESANDAANDA085368
CODESMMSL_CODEBD1701
CODESMMSL_CODEBD6841
CODESMMSL_CODECD6841
CODESRxCUI1235049
CODESSPL_SET_ID0c28458a-cc56-4eea-89aa-d60659bd9568
CODESSPL_SET_ID3c5e1833-9908-4e4f-bdf2-7a28c14a585c
CODESSPL_SET_ID9eea5875-d153-4bba-aee2-b1d1cd8b5e57
CODESVUID4004044
NAMESPrescribable Synonymhydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal Cream
NAMESRXNAV_STRhydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream
NAMESRxNorm Namehydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream
NAMESRxNorm Synonymhydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal Cream
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File