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, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRPramosone (hydrocortisone acetate 2.5 % / pramoxine HCl 1 % ) Topical Lotion1NAMES
RxNorm Namehydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Pramosone]1NAMES
RxNorm SynonymPramosone (hydrocortisone acetate 2.5 % / pramoxine HCl 1 % ) Topical Lotion1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI12345141CODES
MMSL_CODEBD17121CODES

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#

RxNav current and historical NDC rows page 1 of 1 · 11 matching rows.

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PramosoneHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDESebela Pharmaceuticals Inc.63606801-4fa8-11e4-916c-0800200c9a662025-11-08Adverse reactionsExact identifier
ndc (package): 54766-726-04
ndc (package): 54766-726-06
ndc (product): 54766-726
ndc11 (package): 54766072606
ndc11 (package): 54766072604
ndc11 (package): 54766072675
rxcui: 1234514
PramosoneHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.4c98a01e-ff11-45eb-8732-4bd9157969e82025-06-09Adverse reactionsExact identifier
ndc (package): 83107-021-04
ndc (package): 83107-021-02
ndc (product): 83107-021
ndc11 (package): 83107002102
ndc11 (package): 83107002104
rxcui: 1234514

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
63606801-4fa8-11e4-916c-0800200c9a66Pramosone 2.5 % / 1 % Topical Lotion [PSN] · hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Pramosone] [SBD] · Pramosone (hydrocortisone acetate 2.5 % / pramoxine HCl 1 % ) Topical Lotion [SY]37Pramosone ® Lotion (hydrocortisone acetate and pramoxine hydrochloride)20251108
4c98a01e-ff11-45eb-8732-4bd9157969e8Pramosone 2.5 % / 1 % Topical Lotion [PSN] · hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Pramosone] [SBD] · Pramosone (hydrocortisone acetate 2.5 % / pramoxine HCl 1 % ) Topical Lotion [SY]31Pramosone ® Lotion 2.5% hydrocortisone acetate 2.5% pramoxine hydrochloride 1%20250609

Recently Linked 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
9a1e1487-603e-4e8a-8e58-95036d93f229National Council for Prescription Drug Programs20120724
e8d21ed3-a534-4b7b-91df-203a8eab7236National 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_STRENGTH25 MG/ML (expressed as hydrocortisone acetate) / 10 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA085979
NAMESPrescribable SynonymPramosone 2.5 % / 1 % Topical Lotion
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon