FDA.reportPublic FDA data

hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream [Pramosone]

RxCUI
1234519
RxNorm name
hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream [Pramosone]
Display name
PRAMOSONE (Topical)
Full name
hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream [Pramosone]
Term type
SBD
Status
Active
Strength
1-1%
Dose form
Cream
Route
Topical
Updated
2026-07-17 22:20:18

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
pramoxine hydrochloride10 MG / 1 MLpramoxinepramoxine hydrochloride
hydrocortisone acetate10 MG / 1 MLhydrocortisonehydrocortisone acetate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Cream316982

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
pramoxine34347
hydrocortisone5492

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRPramosone (hydrocortisone acetate 1 % / pramoxine HCl 1 % ) Topical CreamNAMES
RxNorm Namehydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream [Pramosone]NAMES
RxNorm SynonymPramosone (hydrocortisone acetate 1 % / pramoxine HCl 1 % ) Topical CreamNAMES
TTYSBDATTRIBUTES
SPL_SET_ID3e8422e0-3bb3-11e5-8cb0-0002a5d5c51bCODES
SPL_SET_ID6a9fb75b-a2f7-4eca-8dce-d7eb5c122476CODES
RxCUI1234519CODES
MMSL_CODEBD1701CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
54766-716-0354766-716Pramosone Cream hydrocortisone acetate and pramoxine hydrochlorideSebela Pharmaceuticals Inc.ANDA085368
54766-716-0454766-716Pramosone Cream hydrocortisone acetate and pramoxine hydrochlorideSebela Pharmaceuticals Inc.ANDA085368
83107-016-0283107-016Pramosone Cream hydrocortisone acetate and pramoxine hydrochlorideLegacy Pharma USA Inc.ANDA085368
83107-017-0183107-017Pramosone Cream hydrocortisone acetate and pramoxine hydrochlorideLegacy Pharma USA Inc.ANDA085368

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA08536854766-716Pramosone Cream hydrocortisone acetate and pramoxine hydrochlorideANDASebela Pharmaceuticals Inc.

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
54766071603rxnav_ndcsyes
54766071604rxnav_ndcsyes
83107001602rxnav_ndcsyes
83107001701rxnav_ndcsyes
00496071603rxnav_historical
00496071604rxnav_historical
00496071633rxnav_historical
54569341100rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
3e8422e0-3bb3-11e5-8cb0-0002a5d5c51bhydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream [Pramosone]SBD4Pramosone ® (hydrocortisone acetate 1% pramoxine hydrochloride 1%) Cream 1%20251108
3e8422e0-3bb3-11e5-8cb0-0002a5d5c51bPramosone (hydrocortisone acetate 1 % / pramoxine HCl 1 % ) Topical CreamSY4Pramosone ® (hydrocortisone acetate 1% pramoxine hydrochloride 1%) Cream 1%20251108
3e8422e0-3bb3-11e5-8cb0-0002a5d5c51bPramosone (hydrocortisone acetate 1 % / pramoxine HCl 1 % ) Topical CreamPSN4Pramosone ® (hydrocortisone acetate 1% pramoxine hydrochloride 1%) Cream 1%20251108
6a9fb75b-a2f7-4eca-8dce-d7eb5c122476hydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream [Pramosone]SBD1Pramosone ® (hydrocortisone acetate 1% pramoxine HCl 1%) Cream 1%20250630
6a9fb75b-a2f7-4eca-8dce-d7eb5c122476Pramosone (hydrocortisone acetate 1 % / pramoxine HCl 1 % ) Topical CreamPSN1Pramosone ® (hydrocortisone acetate 1% pramoxine HCl 1%) Cream 1%20250630
6a9fb75b-a2f7-4eca-8dce-d7eb5c122476Pramosone (hydrocortisone acetate 1 % / pramoxine HCl 1 % ) Topical CreamSY1Pramosone ® (hydrocortisone acetate 1% pramoxine HCl 1%) Cream 1%20250630

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
3e8422e0-3bb3-11e5-8cb0-0002a5d5c51bPramosone ® (hydrocortisone acetate 1% pramoxine hydrochloride 1%) Cream 1%Sebela Pharmaceuticals Inc. | Ferndale Laboratories, Inc.20251108
6a9fb75b-a2f7-4eca-8dce-d7eb5c122476Pramosone ® (hydrocortisone acetate 1% pramoxine HCl 1%) Cream 1%Legacy Pharma USA Inc.20250630
3e8422e0-3bb3-11e5-8cb0-0002a5d5c51bPramosone ® (hydrocortisone acetate 1% pramoxine hydrochloride 1%) Cream 1%Sebela Pharmaceuticals Inc. | Ferndale Laboratories, Inc.20171215

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
ATTRIBUTESTTYSBD
CODESANDAANDA085368
CODESMMSL_CODEBD1701
CODESRxCUI1234519
CODESSPL_SET_ID3e8422e0-3bb3-11e5-8cb0-0002a5d5c51b
CODESSPL_SET_ID6a9fb75b-a2f7-4eca-8dce-d7eb5c122476
NAMESPrescribable SynonymPramosone (hydrocortisone acetate 1 % / pramoxine HCl 1 % ) Topical Cream
NAMESRXNAV_STRPramosone (hydrocortisone acetate 1 % / pramoxine HCl 1 % ) Topical Cream
NAMESRxNorm Namehydrocortisone acetate 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream [Pramosone]
NAMESRxNorm SynonymPramosone (hydrocortisone acetate 1 % / pramoxine HCl 1 % ) Topical Cream
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon