FDA.reportPublic FDA data

hydrocortisone acetate 0.025 MG/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment [Pramosone]

RxCUI
1234338
RxNorm name
hydrocortisone acetate 0.025 MG/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment [Pramosone]
Display name
PRAMOSONE (Topical)
Full name
hydrocortisone acetate 0.025 MG/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment [Pramosone]
Term type
SBD
Status
Active
Strength
2.5-1%
Dose form
Ointment
Route
Topical
Updated
2026-07-17 22:19:44

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 hydrochloride0.01 MG / 1 MGpramoxinepramoxine hydrochloride
hydrocortisone acetate0.025 MG / 1 MGhydrocortisonehydrocortisone acetate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Ointment316985

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
pramoxine34347
hydrocortisone5492

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRPramosone (hydrocortisone acetate 2.5 % / pramoxine HCl 1 % ) Topical OintmentNAMES
RxNorm Namehydrocortisone acetate 0.025 MG/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment [Pramosone]NAMES
RxNorm SynonymPramosone (hydrocortisone acetate 2.5 % / pramoxine HCl 1 % ) Topical OintmentNAMES
TTYSBDATTRIBUTES
SPL_SET_ID4d4e288e-00d7-ed9d-e063-6394a90aab31CODES
SPL_SET_IDb955de80-3bb5-11e5-ac7f-0002a5d5c51bCODES
RxCUI1234338CODES
MMSL_CODEBD1714CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
83107-014-0183107-014Pramosone hydrocortisone acetate and pramoxine hydrochlorideLegacy Pharma USA Inc

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
54766077704rxnav_ndcsyes
83107001401rxnav_ndcsyes
00496077704rxnav_historical
00496077733rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
4d4e288e-00d7-ed9d-e063-6394a90aab31Pramosone (hydrocortisone acetate 2.5 % / pramoxine HCl 1 % ) Topical OintmentSY1Pramosone ® Ointment (hydrocortisone acetate and pramoxine hydrochloride)20260318
4d4e288e-00d7-ed9d-e063-6394a90aab31Pramosone 2.5 % / 1 % Topical OintmentPSN1Pramosone ® Ointment (hydrocortisone acetate and pramoxine hydrochloride)20260318
4d4e288e-00d7-ed9d-e063-6394a90aab31hydrocortisone acetate 0.025 MG/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment [Pramosone]SBD1Pramosone ® Ointment (hydrocortisone acetate and pramoxine hydrochloride)20260318

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
b955de80-3bb5-11e5-ac7f-0002a5d5c51bPramosone ® Ointment (hydrocortisone acetate and pramoxine hydrochloride)Sebela Pharmaceuticals Inc.20260529
4d4e288e-00d7-ed9d-e063-6394a90aab31Pramosone ® Ointment (hydrocortisone acetate and pramoxine hydrochloride)Legacy Pharma USA Inc20260318
b955de80-3bb5-11e5-ac7f-0002a5d5c51bPramosone ® Ointment (hydrocortisone acetate and pramoxine hydrochloride)Sebela Pharmaceuticals Inc. | Ferndale Laboratories, Inc. | Albemarle Corporation20251108
b955de80-3bb5-11e5-ac7f-0002a5d5c51bPramosone ® Ointment (hydrocortisone acetate and pramoxine hydrochloride)Sebela Pharmaceuticals Inc. | Ferndale Laboratories, Inc. | Albemarle Corporation20171215

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_STRENGTH0.025 MG/MG (expressed as hydrocortisone acetate) / 0.01 MG/MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD1714
CODESRxCUI1234338
CODESSPL_SET_ID4d4e288e-00d7-ed9d-e063-6394a90aab31
CODESSPL_SET_IDb955de80-3bb5-11e5-ac7f-0002a5d5c51b
NAMESPrescribable SynonymPramosone 2.5 % / 1 % Topical Ointment
NAMESRXNAV_STRPramosone (hydrocortisone acetate 2.5 % / pramoxine HCl 1 % ) Topical Ointment
NAMESRxNorm Namehydrocortisone acetate 0.025 MG/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment [Pramosone]
NAMESRxNorm SynonymPramosone (hydrocortisone acetate 2.5 % / pramoxine HCl 1 % ) Topical Ointment
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon