FDA.reportPublic FDA data

hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Pramosone]

RxCUI
1234514
RxNorm name
hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Pramosone]
Display name
PRAMOSONE (Topical)
Full name
hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Pramosone]
Term type
SBD
Status
Active
Strength
2.5-1%
Dose form
Lotion
Route
Topical
Updated
2026-07-17 22:20:15

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 acetate25 MG / 1 MLhydrocortisonehydrocortisone acetate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Lotion316983

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 LotionNAMES
RxNorm Namehydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Pramosone]NAMES
RxNorm SynonymPramosone (hydrocortisone acetate 2.5 % / pramoxine HCl 1 % ) Topical LotionNAMES
TTYSBDATTRIBUTES
SPL_SET_ID4c98a01e-ff11-45eb-8732-4bd9157969e8CODES
SPL_SET_ID63606801-4fa8-11e4-916c-0800200c9a66CODES
RxCUI1234514CODES
MMSL_CODEBD1712CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
54766-726-0454766-726Pramosone hydrocortisone acetate and pramoxine hydrochlorideSebela Pharmaceuticals Inc.ANDA085979
54766-726-0654766-726Pramosone hydrocortisone acetate and pramoxine hydrochlorideSebela Pharmaceuticals Inc.ANDA085979
83107-021-0283107-021Pramosone hydrocortisone acetate and pramoxine hydrochlorideLegacy Pharma USA Inc.ANDA085979
83107-021-0483107-021Pramosone hydrocortisone acetate and pramoxine hydrochlorideLegacy Pharma USA Inc.ANDA085979

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA08597954766-726Pramosone hydrocortisone acetate and pramoxine hydrochlorideANDASebela Pharmaceuticals Inc.

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
54766072604rxnav_ndcsyes
54766072606rxnav_ndcsyes
54766072675rxnav_ndcsyes
83107002102rxnav_ndcsyes
83107002104rxnav_ndcsyes
00496072604rxnav_historical
00496072606rxnav_historical
00496072675rxnav_historical
54569116100rxnav_historical
58118992001rxnav_historical
58118992005rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
63606801-4fa8-11e4-916c-0800200c9a66hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Pramosone]SBD7Pramosone ® Lotion (hydrocortisone acetate and pramoxine hydrochloride)20251108
63606801-4fa8-11e4-916c-0800200c9a66Pramosone 2.5 % / 1 % Topical LotionPSN7Pramosone ® Lotion (hydrocortisone acetate and pramoxine hydrochloride)20251108
63606801-4fa8-11e4-916c-0800200c9a66Pramosone (hydrocortisone acetate 2.5 % / pramoxine HCl 1 % ) Topical LotionSY7Pramosone ® Lotion (hydrocortisone acetate and pramoxine hydrochloride)20251108
4c98a01e-ff11-45eb-8732-4bd9157969e8hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Pramosone]SBD1Pramosone ® Lotion 2.5% hydrocortisone acetate 2.5% pramoxine hydrochloride 1%20250609
4c98a01e-ff11-45eb-8732-4bd9157969e8Pramosone 2.5 % / 1 % Topical LotionPSN1Pramosone ® Lotion 2.5% hydrocortisone acetate 2.5% pramoxine hydrochloride 1%20250609
4c98a01e-ff11-45eb-8732-4bd9157969e8Pramosone (hydrocortisone acetate 2.5 % / pramoxine HCl 1 % ) Topical LotionSY1Pramosone ® Lotion 2.5% hydrocortisone acetate 2.5% pramoxine hydrochloride 1%20250609

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
63606801-4fa8-11e4-916c-0800200c9a66Pramosone ® Lotion (hydrocortisone acetate and pramoxine hydrochloride)Sebela Pharmaceuticals Inc. | Ferndale Laboratories, Inc.20251108
4c98a01e-ff11-45eb-8732-4bd9157969e8Pramosone ® Lotion 2.5% hydrocortisone acetate 2.5% pramoxine hydrochloride 1%Legacy Pharma USA Inc.20250609
63606801-4fa8-11e4-916c-0800200c9a66Pramosone ® Lotion (hydrocortisone acetate and pramoxine hydrochloride)Sebela Pharmaceuticals Inc. | Ferndale Laboratories, Inc.20231206

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_CODEBD1712
CODESRxCUI1234514
CODESSPL_SET_ID4c98a01e-ff11-45eb-8732-4bd9157969e8
CODESSPL_SET_ID63606801-4fa8-11e4-916c-0800200c9a66
NAMESPrescribable SynonymPramosone 2.5 % / 1 % Topical Lotion
NAMESRXNAV_STRPramosone (hydrocortisone acetate 2.5 % / pramoxine HCl 1 % ) Topical Lotion
NAMESRxNorm Namehydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Pramosone]
NAMESRxNorm SynonymPramosone (hydrocortisone acetate 2.5 % / pramoxine HCl 1 % ) Topical Lotion
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon