FDA.reportPublic FDA data

hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [Analpram HC]

RxCUI
1362211
RxNorm name
hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [Analpram HC]
Display name
ANALPRAM HC (Rectal)
Full name
hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [Analpram HC]
Term type
SBD
Status
Active
Strength
2.5-1%
Dose form
Cream
Route
Rectal
Updated
2026-07-24 06:53:13

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012013
Active start
012013
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
pramoxine hydrochloride10 MG / 1 MLpramoxinepramoxine hydrochloride
hydrocortisone acetate25 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_STRAnalpram HC 2.5 % / 1 % (hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % ) Rectal CreamNAMES
RxNorm Namehydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [Analpram HC]NAMES
RxNorm SynonymAnalpram HC 2.5 % / 1 % (hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % ) Rectal CreamNAMES
TTYSBDATTRIBUTES
SPL_SET_ID3e5c6728-ece3-40f7-9e36-cff71f168cd8CODES
SPL_SET_IDfecf8380-3bb5-11e5-98c5-0002a5d5c51bCODES
RxCUI1362211CODES
MMSL_CODEBD1709CODES
MMSL_CODEBD6842CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
54766-799-0454766-799Analpram HC hydrocortisone acetate and pramoxine hydrochlorideSebela Pharmaceuticals Inc.
54766-799-6554766-799Analpram HC hydrocortisone acetate and pramoxine hydrochlorideSebela Pharmaceuticals Inc.
83107-019-1283107-019Analpram HC hydrocortisone acetate and pramoxine hydrochlorideLegacy Pharma USA Inc.ANDA085979
83107-019-3083107-019Analpram HC hydrocortisone acetate and pramoxine hydrochlorideLegacy Pharma USA Inc.ANDA085979

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA08597983107-019Analpram HC hydrocortisone acetate and pramoxine hydrochlorideANDALegacy Pharma USA Inc.

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
54766079904rxnav_ndcsyes
54766079933rxnav_ndcsyes
54766079936rxnav_ndcsyes
54766079964rxnav_ndcsyes
54766079965rxnav_ndcsyes
54766079971rxnav_ndcsyes
54766079972rxnav_ndcsyes
83107001901rxnav_ndcsyes
83107001904rxnav_ndcsyes
83107001912rxnav_ndcsyes
83107001930rxnav_ndcsyes
00496075504rxnav_historical_indirect
00496075533rxnav_historical_indirect
00496075536rxnav_historical_indirect
00496075564rxnav_historical_indirect
00496079904rxnav_historical_indirect
00496079933rxnav_historical_indirect
00496079936rxnav_historical_indirect
00496079964rxnav_historical_indirect
00496079965rxnav_historical_indirect
00496080004rxnav_historical_indirect
00496080033rxnav_historical_indirect
00496080064rxnav_historical_indirect
00496080065rxnav_historical_indirect
00496080074rxnav_historical_indirect
54766075504rxnav_historical
54766075536rxnav_historical
54766075564rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
fecf8380-3bb5-11e5-98c5-0002a5d5c51bhydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [Analpram HC]SBD9Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%20251108
fecf8380-3bb5-11e5-98c5-0002a5d5c51bAnalpram HC 2.5 % / 1 % (hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % ) Rectal CreamSY9Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%20251108
fecf8380-3bb5-11e5-98c5-0002a5d5c51bAnalpram 2.5 % / 1 % Rectal CreamPSN9Analpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%20251108
3e5c6728-ece3-40f7-9e36-cff71f168cd8Analpram HC 2.5 % / 1 % (hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % ) Rectal CreamSY2Analpram HC ® hydrocortisone acetate 2.5% pramoxine HCl 1% Cream 2.5%20260324
3e5c6728-ece3-40f7-9e36-cff71f168cd8hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [Analpram HC]SBD2Analpram HC ® hydrocortisone acetate 2.5% pramoxine HCl 1% Cream 2.5%20260324
3e5c6728-ece3-40f7-9e36-cff71f168cd8Analpram 2.5 % / 1 % Rectal CreamPSN2Analpram HC ® hydrocortisone acetate 2.5% pramoxine HCl 1% Cream 2.5%20260324

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
3e5c6728-ece3-40f7-9e36-cff71f168cd8Analpram HC ® hydrocortisone acetate 2.5% pramoxine HCl 1% Cream 2.5%Legacy Pharma USA Inc.20260324
fecf8380-3bb5-11e5-98c5-0002a5d5c51bAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%Sebela Pharmaceuticals Inc. | Ferndale Laboratories, Inc.20251108
fecf8380-3bb5-11e5-98c5-0002a5d5c51bAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%Sebela Pharmaceuticals Inc. | Ferndale Laboratories, Inc.20241111

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_STRENGTH25 MG/ML (expressed as hydrocortisone acetate) / 10 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESANDAANDA085979
CODESMMSL_CODEBD1709
CODESMMSL_CODEBD6842
CODESRxCUI1362211
CODESSPL_SET_ID3e5c6728-ece3-40f7-9e36-cff71f168cd8
CODESSPL_SET_IDfecf8380-3bb5-11e5-98c5-0002a5d5c51b
NAMESPrescribable SynonymAnalpram 2.5 % / 1 % Rectal Cream
NAMESRXNAV_STRAnalpram HC 2.5 % / 1 % (hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % ) Rectal Cream
NAMESRxNorm Namehydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [Analpram HC]
NAMESRxNorm SynonymAnalpram HC 2.5 % / 1 % (hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % ) Rectal Cream
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon