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#

RxNav current and historical NDC rows page 1 of 1 · 93 matching rows.

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

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
fluocinolone acetonideFLUOCINOLONE ACETONIDEANI Pharmaceuticals, Inc.50e7006d-a51b-49aa-8e1c-330340e7bf822026-02-23Adverse reactionsExact identifier
ndc (package): 62559-288-60
ndc (package): 62559-288-15
ndc (product): 62559-288
ndc11 (package): 62559028860
ndc11 (package): 62559028815
rxcui: 1191302
Fluocinolone AcetonideFLUOCINOLONE ACETONIDECosette Pharmaceuticals, Inc.de5b78ab-ff79-3e0f-cad4-ecab11ebbdcd2023-11-22Adverse reactionsExact identifier
ndc (package): 0713-0223-15
ndc (package): 0713-0223-60
ndc (product): 0713-0223
ndc11 (package): 00713022360
ndc11 (package): 00713022315
rxcui: 1191302

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
f0b227f4-df9c-476c-95ce-31d864758f33FLUOCINOLONE ACETONIDE CREAM, USP 0.01%, 0.025%E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.20121115
573465ef-d6ce-4576-a1dc-2641147a17e4National Council for Prescription Drug Programs20120724
9a4a4837-7b09-4903-a3d6-9805b57f912fNational Council for Prescription Drug Programs20120724
b24b9aa1-b437-4a92-a2c6-94094a9a2c40National Council for Prescription Drug Programs20120724
b5073426-5541-4399-869c-86c0f6bc144aNational Council for Prescription Drug Programs20120724
fb810831-6c1e-49db-8b73-16815d8e1c70National Council for Prescription Drug Programs20120724
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