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, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRhydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream1NAMES
RxNorm Namehydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream1NAMES
RxNorm Synonymhydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal Cream1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI12350491CODES
MMSL_CODE
3 linked values
3CODES

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#

RxNav current and historical NDC rows page 1 of 1 · 12 matching rows.

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

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Analpram HCHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.39618fc5-87a8-47bc-93fc-cb97b8f663c82025-06-24Adverse reactionsExact identifier
rxcui: 1235049
hydrocortisone acetate pramoxine hclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack0c28458a-cc56-4eea-89aa-d60659bd95682023-08-17Adverse reactionsExact identifier
ndc (package): 72162-1399-3
ndc (product): 72162-1399
ndc11 (package): 72162139903
rxcui: 1235049
hydrocortisone acetate pramoxine hclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack3c5e1833-9908-4e4f-bdf2-7a28c14a585c2023-07-18Adverse reactionsExact identifier
ndc (package): 63629-8669-1
ndc (product): 63629-8669
ndc11 (package): 63629866901
rxcui: 1235049
hydrocortisone acetate pramoxine hclHYDROCORTISONE ACETATE PRAMOXINE HCLPadagis Israel Pharmaceuticals Ltd9eea5875-d153-4bba-aee2-b1d1cd8b5e572022-05-31Adverse reactionsExact identifier
ndc (package): 45802-144-64
ndc (product): 45802-144
ndc11 (package): 45802014464
rxcui: 1235049

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3c5e1833-9908-4e4f-bdf2-7a28c14a585chydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal Cream [PSN] · hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [SCD] · hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal Cream [SY]3104Hydrocortisone Acetate 1% Pramoxine HCl 1% Cream20230718
0c28458a-cc56-4eea-89aa-d60659bd9568hydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal Cream [PSN] · hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [SCD] · hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal Cream [SY]3100Hydrocortisone Acetate 1% Pramoxine HCl 1% Cream20230817
9eea5875-d153-4bba-aee2-b1d1cd8b5e57hydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal Cream [PSN] · hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [SCD] · hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal Cream [SY]35Hydrocortisone Acetate 1% Pramoxine HCl 1% Cream20220531
27b3c751-d972-4cb9-9235-55e29953bf8dhydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal Cream [PSN] · hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [SCD] · hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal Cream [SY]34Analpram HC ® (hydrocortisone acetate 1% pramoxine HCl 1%) Cream 1%20251108
39618fc5-87a8-47bc-93fc-cb97b8f663c8hydrocortisone acetate 1 % / pramoxine HCl 1 % Rectal Cream [PSN] · hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [SCD] · hydrocortisone acetate 1 % / pramoxine hydrochloride 1 % Rectal Cream [SY]31Analpram HC ® (hydrocortisone acetate 1% pramoxine HCl 1%) Cream 1%20250624

Recently Linked 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
2ba46a04-a083-4d66-84b9-3c88945b20a3National Council for Prescription Drug Programs20130213
1d40c8cd-39cd-4587-8825-dd410e93aafcNational Council for Prescription Drug Programs20120724

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
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA085368
CODESVUID4004044
NAMESPrescribable Synonymhydrocortisone acetate 1 % / pramoxine HCl 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