FDA.reportPublic FDA data

fluocinolone acetonide 0.1 MG/ML Topical Cream

RxCUI
1191302
RxNorm name
fluocinolone acetonide 0.1 MG/ML Topical Cream
Display name
Fluocinolone (Topical)
Full name
fluocinolone acetonide 0.1 MG/ML Topical Cream
Term type
SCD
Status
Active
Strength
0.01%
Dose form
Cream
Route
Topical
Updated
2026-07-18 07:00:02

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112011
Active start
112011
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
fluocinolone acetonide0.1 MG / 1 MLfluocinolonefluocinolone acetonide

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Cream316982

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
fluocinolone25126

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRfluocinolone acetonide 0.1 MG/ML Topical CreamNAMES
RxNorm Namefluocinolone acetonide 0.1 MG/ML Topical CreamNAMES
RxNorm Synonymfluocinolone acetonide 0.01 % Topical CreamNAMES
TTYSCDATTRIBUTES
SPL_SET_ID50e7006d-a51b-49aa-8e1c-330340e7bf82CODES
SPL_SET_IDde5b78ab-ff79-3e0f-cad4-ecab11ebbdcdCODES
RxCUI1191302CODES
MMSL_CODEBD3118CODES
MMSL_CODECD3118CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0713-0223-150713-0223Fluocinolone Acetonide Fluocinolone AcetonideCosette Pharmaceuticals, Inc.ANDA089526
0713-0223-600713-0223Fluocinolone Acetonide Fluocinolone AcetonideCosette Pharmaceuticals, Inc.ANDA089526
62559-288-1562559-288fluocinolone acetonide fluocinolone acetonideANI Pharmaceuticals, Inc.NDA012787
62559-288-6062559-288fluocinolone acetonide fluocinolone acetonideANI Pharmaceuticals, Inc.NDA012787

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA0895260713-0223Fluocinolone Acetonide Fluocinolone AcetonideANDACosette Pharmaceuticals, Inc.
NDA01278762559-288fluocinolone acetonide fluocinolone acetonideNDA AUTHORIZED GENERICANI Pharmaceuticals, Inc.

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
00168005815rxnav_ndcsyes
00168005860rxnav_ndcsyes
00247096215rxnav_ndcsyes
00713022315rxnav_ndcsyes
00713022360rxnav_ndcsyes
52565003115rxnav_ndcsyes
52565003160rxnav_ndcsyes
52959031400rxnav_ndcsyes
62559028815rxnav_ndcsyes
62559028860rxnav_ndcsyes
00033250213rxnav_historical_indirect
00033250214rxnav_historical_indirect
00033250217rxnav_historical_indirect
00033250222rxnav_historical_indirect
00033250223rxnav_historical_indirect
00033250271rxnav_historical_indirect
00157029216rxnav_historical_indirect
00157029244rxnav_historical_indirect
00157029260rxnav_historical_indirect
00182114951rxnav_historical_indirect
00182114952rxnav_historical_indirect
00182114959rxnav_historical_indirect
00223429713rxnav_historical_indirect
00223429715rxnav_historical_indirect
00223429760rxnav_historical_indirect
00302300015rxnav_historical_indirect
00364726258rxnav_historical_indirect
00364726272rxnav_historical_indirect
00462005815rxnav_historical_indirect
00462005860rxnav_historical_indirect
00536443120rxnav_historical_indirect
00536443125rxnav_historical_indirect
00536443198rxnav_historical_indirect
00603774774rxnav_historical_indirect
00603774788rxnav_historical_indirect
00677071340rxnav_historical_indirect
00677071343rxnav_historical_indirect
00686006735rxnav_historical_indirect
00686014220rxnav_historical_indirect
00686014224rxnav_historical_indirect
00701048615rxnav_historical_indirect
00701048630rxnav_historical_indirect
00701048645rxnav_historical_indirect
00701048660rxnav_historical_indirect
00781700327rxnav_historical_indirect
00781700335rxnav_historical_indirect
00814318884rxnav_historical_indirect
00814318891rxnav_historical_indirect
00814318893rxnav_historical_indirect
00839634647rxnav_historical_indirect
00839634650rxnav_historical_indirect
00839634699rxnav_historical_indirect
00904266002rxnav_historical_indirect
16590009715rxnav_historical_indirect
19458057601rxnav_historical_indirect
21695092815rxnav_historical_indirect
23317036115rxnav_historical_indirect
23317036160rxnav_historical_indirect
23490558300rxnav_historical_indirect
24208045056rxnav_historical_indirect
24208045057rxnav_historical_indirect
24208045089rxnav_historical_indirect
24208045092rxnav_historical_indirect
24208045093rxnav_historical_indirect
24208045097rxnav_historical_indirect
33261086401rxnav_historical
45802006735rxnav_historical_indirect
45802006737rxnav_historical_indirect
45802006738rxnav_historical_indirect
48695114701rxnav_historical_indirect
48695114703rxnav_historical_indirect
48695114705rxnav_historical_indirect
48695119903rxnav_historical_indirect
49158014220rxnav_historical_indirect
49158014223rxnav_historical_indirect
49158014224rxnav_historical_indirect
49427040512rxnav_historical_indirect
51079026661rxnav_historical_indirect
51432072010rxnav_historical_indirect
51432072017rxnav_historical_indirect
52446091174rxnav_historical_indirect
52446091188rxnav_historical_indirect
52493037215rxnav_historical_indirect
52493037260rxnav_historical_indirect
53002082363rxnav_historical_indirect
53002082368rxnav_historical_indirect
54569154400rxnav_historical_indirect
54868366000rxnav_historical_indirect
54868366001rxnav_historical_indirect
55045132607rxnav_historical_indirect
58016308301rxnav_historical_indirect
68258398701rxnav_historical
68788005806rxnav_historical_indirect

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
de5b78ab-ff79-3e0f-cad4-ecab11ebbdcdfluocinolone acetonide 0.1 MG/ML Topical CreamSCD18Fluocinolone Acetonide Cream, USP 0.01% Fluocinolone Acetonide Cream, USP 0.025% Fluocinolone Acetonide Ointment, USP 0.025% Topical Corticosteroid20231122
de5b78ab-ff79-3e0f-cad4-ecab11ebbdcdfluocinolone acetonide 0.01 % Topical CreamPSN18Fluocinolone Acetonide Cream, USP 0.01% Fluocinolone Acetonide Cream, USP 0.025% Fluocinolone Acetonide Ointment, USP 0.025% Topical Corticosteroid20231122
de5b78ab-ff79-3e0f-cad4-ecab11ebbdcdfluocinolone acetonide 0.01 % Topical CreamSY18Fluocinolone Acetonide Cream, USP 0.01% Fluocinolone Acetonide Cream, USP 0.025% Fluocinolone Acetonide Ointment, USP 0.025% Topical Corticosteroid20231122
da65dffd-a017-46dd-8a5b-a4e4574c4abcfluocinolone acetonide 0.1 MG/ML Topical CreamSCD4Fluocinolone Acetonide Cream USP, 0.01%, 0.025%20140507
da65dffd-a017-46dd-8a5b-a4e4574c4abcfluocinolone acetonide 0.01 % Topical CreamSY4Fluocinolone Acetonide Cream USP, 0.01%, 0.025%20140507
da65dffd-a017-46dd-8a5b-a4e4574c4abcfluocinolone acetonide 0.01 % Topical CreamPSN4Fluocinolone Acetonide Cream USP, 0.01%, 0.025%20140507
50e7006d-a51b-49aa-8e1c-330340e7bf82fluocinolone acetonide 0.01 % Topical CreamPSN3Fluocinolone Acetonide Cream USP, 0.01% and 0.025% Rx Only20260223
50e7006d-a51b-49aa-8e1c-330340e7bf82fluocinolone acetonide 0.01 % Topical CreamSY3Fluocinolone Acetonide Cream USP, 0.01% and 0.025% Rx Only20260223
50e7006d-a51b-49aa-8e1c-330340e7bf82fluocinolone acetonide 0.1 MG/ML Topical CreamSCD3Fluocinolone Acetonide Cream USP, 0.01% and 0.025% Rx Only20260223
cdc77f53-e9f6-486e-896a-069bc7ec47fdfluocinolone acetonide 0.01 % Topical CreamPSN120110222
cdc77f53-e9f6-486e-896a-069bc7ec47fdfluocinolone acetonide 0.1 MG/ML Topical CreamSCD120110222
cdc77f53-e9f6-486e-896a-069bc7ec47fdfluocinolone acetonide 0.01 % Topical CreamSY120110222

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
50e7006d-a51b-49aa-8e1c-330340e7bf82Fluocinolone Acetonide Cream USP, 0.01% and 0.025% Rx OnlyANI Pharmaceuticals, Inc.20260223
de5b78ab-ff79-3e0f-cad4-ecab11ebbdcdFluocinolone Acetonide Cream, USP 0.01% Fluocinolone Acetonide Cream, USP 0.025% Fluocinolone Acetonide Ointment, USP 0.025% Topical CorticosteroidCosette Pharmaceuticals, Inc. | Cosette Pharmaceuticals NC Laboratories, LLC20231122
da65dffd-a017-46dd-8a5b-a4e4574c4abcFluocinolone Acetonide Cream USP, 0.01%, 0.025%Teligent Pharma, Inc.20140507
cdc77f53-e9f6-486e-896a-069bc7ec47fdSTAT RX USA LLC20110222

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCS02BACorticosteroidsATC1-4fluocinolone acetonide
ATCC05AACorticosteroidsATC1-4fluocinolone acetonide
ATCS01BACorticosteroids, plainATC1-4fluocinolone acetonide
ATCD07ACCorticosteroids, potent (group III)ATC1-4fluocinolone acetonide
FDASPLN0000175576CorticosteroidEPChas_epcfluocinolone acetonide
FDASPLN0000175450Corticosteroid Hormone Receptor AgonistsMOAhas_moafluocinolone acetonide
MEDRTD005446Fluocinolone AcetonideCHEMhas_ingredientfluocinolone
MEDRTD005446Fluocinolone AcetonideCHEMhas_ingredientfluocinolone acetonide
MEDRTD003876Dermatitis, AtopicDISEASEmay_treatfluocinolone
MEDRTD003876Dermatitis, AtopicDISEASEmay_treatfluocinolone acetonide
MEDRTD004342Drug HypersensitivityDISEASEci_withfluocinolone
MEDRTD004342Drug HypersensitivityDISEASEci_withfluocinolone acetonide
MEDRTD005148Facial DermatosesDISEASEmay_treatfluocinolone
MEDRTD005148Facial DermatosesDISEASEmay_treatfluocinolone acetonide
MEDRTD005533Foot DermatosesDISEASEmay_treatfluocinolone
MEDRTD005533Foot DermatosesDISEASEmay_treatfluocinolone acetonide
MEDRTD006229Hand DermatosesDISEASEmay_treatfluocinolone
MEDRTD006229Hand DermatosesDISEASEmay_treatfluocinolone acetonide
MEDRTD006967HypersensitivityDISEASEci_withfluocinolone acetonide
MEDRTD007249InflammationDISEASEmay_treatfluocinolone
MEDRTD007249InflammationDISEASEmay_treatfluocinolone acetonide
MEDRTD007868Leg DermatosesDISEASEmay_treatfluocinolone acetonide
MEDRTD007868Leg DermatosesDISEASEmay_treatfluocinolone
MEDRTD011537PruritusDISEASEmay_treatfluocinolone
MEDRTD011537PruritusDISEASEmay_treatfluocinolone acetonide
MEDRTD011565PsoriasisDISEASEmay_treatfluocinolone acetonide
MEDRTD011565PsoriasisDISEASEmay_treatfluocinolone
MEDRTD012536Scalp DermatosesDISEASEmay_treatfluocinolone acetonide
MEDRTN0000000159Glucocorticoid Receptor AgonistsMOAhas_moafluocinolone acetonide
MEDRTN0000000134Lipoxygenase InhibitorsMOAhas_moafluocinolone acetonide
MEDRTN0000000134Lipoxygenase InhibitorsMOAhas_moafluocinolone
MEDRTN0000008297Antipruritic ActivityPEhas_pefluocinolone acetonide
MEDRTN0000008663Decreased Immunologically Active Molecule ActivityPEhas_pefluocinolone acetonide
MEDRTN0000008663Decreased Immunologically Active Molecule ActivityPEhas_pefluocinolone
MEDRTN0000008841Decreased Protein SynthesisPEhas_pefluocinolone
MEDRTN0000008841Decreased Protein SynthesisPEhas_pefluocinolone acetonide
MEDRTN0000009908VasoconstrictionPEhas_pefluocinolone acetonide
MEDRTN0000009908VasoconstrictionPEhas_pefluocinolone

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.1 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESANDAANDA089526
CODESMMSL_CODEBD3118
CODESMMSL_CODECD3118
CODESRxCUI1191302
CODESSPL_SET_ID50e7006d-a51b-49aa-8e1c-330340e7bf82
CODESSPL_SET_IDde5b78ab-ff79-3e0f-cad4-ecab11ebbdcd
CODESVUID4004177
NAMESPrescribable Synonymfluocinolone acetonide 0.01 % Topical Cream
NAMESRXNAV_STRfluocinolone acetonide 0.1 MG/ML Topical Cream
NAMESRxNorm Namefluocinolone acetonide 0.1 MG/ML Topical Cream
NAMESRxNorm Synonymfluocinolone acetonide 0.01 % Topical Cream
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File