FDA.reportPublic FDA data

hydrocortisone 0.01 MG/MG Topical Ointment [Cortizone]

RxCUI
206314
RxNorm name
hydrocortisone 0.01 MG/MG Topical Ointment [Cortizone]
Display name
CORTIZONE (Topical)
Full name
hydrocortisone 0.01 MG/MG Topical Ointment [Cortizone]
Term type
SBD
Status
Active
Strength
1%
Dose form
Ointment
Route
Topical
Updated
2026-11-08 10:18:01

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
042005
Active start
042005
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
hydrocortisone0.01 MG / 1 MGhydrocortisonehydrocortisone

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Ointment316985

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
hydrocortisone5492

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRCortizone 1 % Topical Ointment1NAMES
RxNorm Namehydrocortisone 0.01 MG/MG Topical Ointment [Cortizone]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID118e55e7-241f-44c4-959e-09bf6221bd771CODES
RxCUI2063141CODES
MMSL_CODEBD16501CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
41167-0344-041167-0344Cortizone 10 Water Resistant HydrocortisoneChattem, Inc.M017
41167-0344-541167-0344Cortizone 10 Water Resistant HydrocortisoneChattem, Inc.M017

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01741167-0344Cortizone 10 Water Resistant HydrocortisoneOTC MONOGRAPH DRUGChattem, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 14 matching rows.

NDC11, Source, Active table
NDC11SourceActive
41167000250rxnav_ndcsyes
41167000255rxnav_ndcsyes
41167000393rxnav_ndcsyes
41167003393rxnav_ndcsyes
41167003396rxnav_ndcsyes
41167034400rxnav_ndcsyes
41167034405rxnav_ndcsyes
00501330501rxnav_historical
00501330502rxnav_historical
41167003903rxnav_historical
41167033903rxnav_historical
41167033906rxnav_historical
74300000393rxnav_historical
74300003396rxnav_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
Cortizone 10 Intensive HealingHYDROCORTISONEChattem, Inc.bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c2025-10-20WarningsExact identifier
ndc11 (package): 41167033903
ndc11 (package): 41167033906
rxcui: 206314
Cortizone 10 Water ResistantHYDROCORTISONEChattem, Inc.118e55e7-241f-44c4-959e-09bf6221bd772025-07-01WarningsExact identifier
ndc (package): 41167-0344-0
ndc (package): 41167-0344-5
ndc (product): 41167-0344
ndc11 (package): 41167034405
ndc11 (package): 41167034400
rxcui: 206314

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
bb3d1a3e-4c0c-4694-9c05-80152dd9bd1cCortizone-10 1 % Topical Ointment [PSN] · hydrocortisone 0.01 MG/MG Topical Ointment [Cortizone] [SBD] · Cortizone 0.01 MG/MG Topical Ointment [SY] · Cortizone 1 % Topical Ointment [SY]416Cortizone-1020251020
118e55e7-241f-44c4-959e-09bf6221bd77Cortizone-10 1 % Topical Ointment [PSN] · hydrocortisone 0.01 MG/MG Topical Ointment [Cortizone] [SBD] · Cortizone 0.01 MG/MG Topical Ointment [SY] · Cortizone 1 % Topical Ointment [SY]44Cortizone 10 Water Resistant Ointment20250701

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
bb3d1a3e-4c0c-4694-9c05-80152dd9bd1cCortizone-10Chattem, Inc.20251020
bb3d1a3e-4c0c-4694-9c05-80152dd9bd1cCortizone-10Chattem, Inc.20250801
118e55e7-241f-44c4-959e-09bf6221bd77Cortizone 10 Water Resistant OintmentChattem, Inc.20250701

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCS02BACorticosteroidsATC1-4hydrocortisone
ATCC05AACorticosteroidsATC1-4hydrocortisone
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
FDASPLN0000175576CorticosteroidEPChas_epchydrocortisone
MEDRTD006854HydrocortisoneCHEMhas_ingredienthydrocortisone
MEDRTD000312Adrenal Hyperplasia, CongenitalDISEASEmay_treathydrocortisone
MEDRTD000309Adrenal InsufficiencyDISEASEmay_treathydrocortisone
MEDRTD003093Colitis, UlcerativeDISEASEmay_treathydrocortisone
MEDRTD003877Dermatitis, ContactDISEASEmay_treathydrocortisone
MEDRTD003881DermatomycosesDISEASEci_withhydrocortisone
MEDRTD004342Drug HypersensitivityDISEASEci_withhydrocortisone
MEDRTD005148Facial DermatosesDISEASEmay_treathydrocortisone
MEDRTD005533Foot DermatosesDISEASEmay_treathydrocortisone
MEDRTD006229Hand DermatosesDISEASEmay_treathydrocortisone
MEDRTD006484HemorrhoidsDISEASEmay_treathydrocortisone
MEDRTD007249InflammationDISEASEmay_treathydrocortisone
MEDRTD007868Leg DermatosesDISEASEmay_treathydrocortisone
MEDRTD011538Pruritus AniDISEASEmay_treathydrocortisone
MEDRTD012216Rheumatic DiseasesDISEASEmay_treathydrocortisone
MEDRTD012536Scalp DermatosesDISEASEmay_treathydrocortisone
MEDRTD012769ShockDISEASEmay_treathydrocortisone
MEDRTD012876Skin Diseases, ParasiticDISEASEci_withhydrocortisone
MEDRTD017193Skin Diseases, ViralDISEASEci_withhydrocortisone
MEDRTD013224Status AsthmaticusDISEASEmay_treathydrocortisone
MEDRTD014382Tuberculosis, CutaneousDISEASEci_withhydrocortisone
MEDRTN0000000159Glucocorticoid Receptor AgonistsMOAhas_moahydrocortisone
MEDRTN0000000134Lipoxygenase InhibitorsMOAhas_moahydrocortisone
MEDRTN0000008327Carbohydrate Metabolism AlterationPEhas_pehydrocortisone
MEDRTN0000010253Decreased Capillary PermeabilityPEhas_pehydrocortisone
MEDRTN0000010248Decreased Fibroblast MigrationPEhas_pehydrocortisone
MEDRTN0000008645Decreased Glucocorticoid SecretionPEhas_pehydrocortisone
MEDRTN0000008681Decreased Leukotriene ActivityPEhas_pehydrocortisone
MEDRTN0000008700Decreased Lysosomal FunctionPEhas_pehydrocortisone
MEDRTN0000010246Decreased Polymorphonuclear Leukocyte MigrationPEhas_pehydrocortisone
MEDRTN0000008834Decreased Prostaglandin ActivityPEhas_pehydrocortisone
MEDRTN0000008841Decreased Protein SynthesisPEhas_pehydrocortisone
MEDRTN0000009004Decreased Thromboxane ActivityPEhas_pehydrocortisone
MEDRTN0000009739Lipid Metabolism AlterationPEhas_pehydrocortisone

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.01 MG/MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable SynonymCortizone-10 1 % Topical Ointment
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon