FDA.reportPublic FDA data

hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream

RxCUI
1234506
RxNorm name
hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream
Display name
Hydrocortisone/Pramoxine (Topical)
Full name
hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream
Term type
SCD
Status
Active
Strength
2.5-1%
Dose form
Cream
Route
Topical
Updated
2026-07-17 22:20:07

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012012
Active start
012012
Multiple ingredient
YES
Branded
NO

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 Cream316982

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
pramoxine34347
hydrocortisone5492

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRhydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamNAMES
RxNorm Namehydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamNAMES
RxNorm Synonymhydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Topical CreamNAMES
TTYSCDATTRIBUTES
SPL_SET_ID1436a6cb-5fa1-41a6-87af-dfbaf0ab2e5bCODES
SPL_SET_ID2c74c1c8-91c7-4468-9b1a-721783431196CODES
SPL_SET_ID982f0862-2be8-4a65-8b61-8f3a95ab5951CODES
SPL_SET_IDc95b9248-b4cc-43ce-acd2-fe20972f87caCODES
SPL_SET_IDd59665d7-a0f4-4318-b452-171c54ed156cCODES
SPL_SET_IDf531fa34-5711-42d0-82c4-3b9943cdcca9CODES
RxCUI1234506CODES
MMSL_CODEBD1709CODES
MMSL_CODECD1709CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
45802-124-1645802-124hydrocortisone acetate pramoxine HCl Hydrocortisone Acetate, Pramoxine HClPadagis Israel Pharmaceuticals Ltd
45802-124-6445802-124hydrocortisone acetate pramoxine HCl Hydrocortisone Acetate, Pramoxine HClPadagis Israel Pharmaceuticals Ltd
52817-817-0152817-817hydrocortisone acetate pramoxine HCl Hydrocortisone Acetate, Pramoxine HClTRUPHARMA, LLC
63629-8673-163629-8673hydrocortisone acetate pramoxine HCl Hydrocortisone Acetate, Pramoxine HClBryant Ranch Prepack
63629-8674-163629-8674hydrocortisone acetate pramoxine HCl Hydrocortisone Acetate, Pramoxine HClBryant Ranch Prepack
71335-2934-171335-2934hydrocortisone acetate pramoxine HCl Hydrocortisone Acetate, Pramoxine HClBryant Ranch Prepack
72162-1394-272162-1394hydrocortisone acetate pramoxine HCl Hydrocortisone Acetate, Pramoxine HClBryant Ranch Prepack
72162-1394-472162-1394hydrocortisone acetate pramoxine HCl Hydrocortisone Acetate, Pramoxine HClBryant Ranch Prepack

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
45802012416rxnav_ndcsyes
45802012464rxnav_ndcsyes
52817081701rxnav_ndcsyes
63629867301rxnav_ndcsyes
63629867401rxnav_ndcsyes
71335293401rxnav_ndcsyes
72162139402rxnav_ndcsyes
72162139404rxnav_ndcsyes
00496071702rxnav_historical_indirect
00496071703rxnav_historical_indirect
00496071704rxnav_historical_indirect
00496071733rxnav_historical_indirect
00496095305rxnav_historical
00496095505rxnav_historical
00904601531rxnav_historical_indirect
11527011655rxnav_historical
42192010701rxnav_historical
45802047201rxnav_historical
45802047253rxnav_historical
45802047264rxnav_historical
45802047265rxnav_historical
49769051901rxnav_historical
49769051902rxnav_historical
50268041330rxnav_historical
52187053301rxnav_historical
52187053401rxnav_historical
54569661600rxnav_historical
58118992205rxnav_historical
65255017807rxnav_historical
67887010130rxnav_historical
69367028501rxnav_historical
71399250101rxnav_historical
71850181201rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
1436a6cb-5fa1-41a6-87af-dfbaf0ab2e5bhydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Topical CreamSY103Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20230718
1436a6cb-5fa1-41a6-87af-dfbaf0ab2e5bhydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD103Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20230718
1436a6cb-5fa1-41a6-87af-dfbaf0ab2e5bhydrocortisone acetate 2.5 % / pramoxine HCl 1 % Topical CreamPSN103Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20230718
2c74c1c8-91c7-4468-9b1a-721783431196hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Topical CreamSY103Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20230718
2c74c1c8-91c7-4468-9b1a-721783431196hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD103Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20230718
2c74c1c8-91c7-4468-9b1a-721783431196hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Topical CreamPSN103Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20230718
c95b9248-b4cc-43ce-acd2-fe20972f87cahydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Topical CreamSY101Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20250221
c95b9248-b4cc-43ce-acd2-fe20972f87cahydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD101Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20250221
c95b9248-b4cc-43ce-acd2-fe20972f87cahydrocortisone acetate 2.5 % / pramoxine HCl 1 % Topical CreamPSN101Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20250221
d59665d7-a0f4-4318-b452-171c54ed156chydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD100Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20251024
d59665d7-a0f4-4318-b452-171c54ed156chydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Topical CreamSY100Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20251024
d59665d7-a0f4-4318-b452-171c54ed156chydrocortisone acetate 2.5 % / pramoxine HCl 1 % Topical CreamPSN100Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20251024
982f0862-2be8-4a65-8b61-8f3a95ab5951hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD5Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20220531
982f0862-2be8-4a65-8b61-8f3a95ab5951hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Topical CreamPSN5Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20220531
982f0862-2be8-4a65-8b61-8f3a95ab5951hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Topical CreamSY5Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20220531
f531fa34-5711-42d0-82c4-3b9943cdcca9hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD4Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20241227
f531fa34-5711-42d0-82c4-3b9943cdcca9hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Topical CreamPSN4Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20241227
f531fa34-5711-42d0-82c4-3b9943cdcca9hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Topical CreamSY4Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream20241227

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
d59665d7-a0f4-4318-b452-171c54ed156cHydrocortisone Acetate 2.5% Pramoxine HCl 1% CreamBryant Ranch Prepack20251024
c95b9248-b4cc-43ce-acd2-fe20972f87caHydrocortisone Acetate 2.5% Pramoxine HCl 1% CreamBryant Ranch Prepack20250221
f531fa34-5711-42d0-82c4-3b9943cdcca9Hydrocortisone Acetate 2.5% Pramoxine HCl 1% CreamTRUPHARMA, LLC | SAPTALIS PHARMACEUTICALS, LLC20241227
1436a6cb-5fa1-41a6-87af-dfbaf0ab2e5bHydrocortisone Acetate 2.5% Pramoxine HCl 1% CreamBryant Ranch Prepack20230718
2c74c1c8-91c7-4468-9b1a-721783431196Hydrocortisone Acetate 2.5% Pramoxine HCl 1% CreamBryant Ranch Prepack20230718
87a4c494-56f9-48f6-8592-d610c507a4fcHydrocortisone Acetate 2.5% Pramoxine HCl 1% CreamPadagis Israel Pharmaceuticals Ltd20220531
982f0862-2be8-4a65-8b61-8f3a95ab5951Hydrocortisone Acetate 2.5% Pramoxine HCl 1% CreamPadagis Israel Pharmaceuticals Ltd20220531

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
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD1709
CODESMMSL_CODECD1709
CODESRxCUI1234506
CODESSNOMEDCT377505006
CODESSPL_SET_ID1436a6cb-5fa1-41a6-87af-dfbaf0ab2e5b
CODESSPL_SET_ID2c74c1c8-91c7-4468-9b1a-721783431196
CODESSPL_SET_ID982f0862-2be8-4a65-8b61-8f3a95ab5951
CODESSPL_SET_IDc95b9248-b4cc-43ce-acd2-fe20972f87ca
CODESSPL_SET_IDd59665d7-a0f4-4318-b452-171c54ed156c
CODESSPL_SET_IDf531fa34-5711-42d0-82c4-3b9943cdcca9
CODESVUID4004046
NAMESPrescribable Synonymhydrocortisone acetate 2.5 % / pramoxine HCl 1 % Topical Cream
NAMESRXNAV_STRhydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream
NAMESRxNorm Namehydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream
NAMESRxNorm Synonymhydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Topical Cream
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceUS Edition of SNOMED_CT