FDA.reportPublic FDA data

fluocinolone acetonide 0.1 MG/ML Otic Solution [Dermotic]

RxCUI
1191301
RxNorm name
fluocinolone acetonide 0.1 MG/ML Otic Solution [Dermotic]
Display name
DERMOTIC (Otic)
Full name
fluocinolone acetonide 0.1 MG/ML Otic Solution [Dermotic]
Term type
SBD
Status
Active
Strength
0.01%
Dose form
Sol
Route
Otic
Updated
2026-07-18 07:00:00

RxNorm Status History#

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

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
Otic Solution316973

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
fluocinolone25126

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRDermotic 0.1 MG/ML Otic SolutionNAMES
RxNorm Namefluocinolone acetonide 0.1 MG/ML Otic Solution [Dermotic]NAMES
RxNorm SynonymDermotic 0.1 MG/ML Otic SolutionNAMES
RxNorm SynonymDermotic Oil 0.01 % (fluocinolone acetonide 0.11 MG/GM) Otic SolutionNAMES
RxNorm SynonymDermotic Oil 0.01 % Otic SolutionNAMES
TTYSBDATTRIBUTES
SPL_SET_IDeb00f222-8105-4e05-90e8-bbd129784364CODES
RxCUI1191301CODES
MMSL_CODEBD18394CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
68791-103-2068791-103DERMOTIC fluocinolone acetonideRoyal PharmaceuticalsNDA019452

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA01945268791-103DERMOTIC fluocinolone acetonideNDARoyal Pharmaceuticals

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 3 matching rows.

NDC11, Source, Active table
NDC11SourceActive
68791010320rxnav_ndcsyes
28105016020rxnav_historical
54868611900rxnav_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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DERMOTICFLUOCINOLONE ACETONIDERoyal Pharmaceuticalseb00f222-8105-4e05-90e8-bbd1297843642025-05-09Warnings, Adverse reactionsExact identifier
ndc (package): 68791-103-20
ndc (product): 68791-103
ndc11 (package): 68791010320
rxcui: 1191301

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
eb00f222-8105-4e05-90e8-bbd129784364DermOtic Oil 0.01 % Otic SolutionPSN14These highlights do not include all the information needed to use DERMOTIC OIL safely and effectively. See full prescribing information for DERMOTIC OIL. DERMOTIC OIL (fluocinolone acetonide) ear drops, for otic use Initial U.S. Approval: 198820250509
eb00f222-8105-4e05-90e8-bbd129784364Dermotic 0.1 MG/ML Otic SolutionSY14These highlights do not include all the information needed to use DERMOTIC OIL safely and effectively. See full prescribing information for DERMOTIC OIL. DERMOTIC OIL (fluocinolone acetonide) ear drops, for otic use Initial U.S. Approval: 198820250509
eb00f222-8105-4e05-90e8-bbd129784364Dermotic Oil 0.01 % (fluocinolone acetonide 0.11 MG/GM) Otic SolutionSY14These highlights do not include all the information needed to use DERMOTIC OIL safely and effectively. See full prescribing information for DERMOTIC OIL. DERMOTIC OIL (fluocinolone acetonide) ear drops, for otic use Initial U.S. Approval: 198820250509
eb00f222-8105-4e05-90e8-bbd129784364Dermotic Oil 0.01 % Otic SolutionSY14These highlights do not include all the information needed to use DERMOTIC OIL safely and effectively. See full prescribing information for DERMOTIC OIL. DERMOTIC OIL (fluocinolone acetonide) ear drops, for otic use Initial U.S. Approval: 198820250509
eb00f222-8105-4e05-90e8-bbd129784364fluocinolone acetonide 0.1 MG/ML Otic Solution [Dermotic]SBD14These highlights do not include all the information needed to use DERMOTIC OIL safely and effectively. See full prescribing information for DERMOTIC OIL. DERMOTIC OIL (fluocinolone acetonide) ear drops, for otic use Initial U.S. Approval: 198820250509

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
eb00f222-8105-4e05-90e8-bbd129784364These highlights do not include all the information needed to use DERMOTIC OIL safely and effectively. See full prescribing information for DERMOTIC OIL. DERMOTIC OIL (fluocinolone acetonide) ear drops, for otic use Initial U.S. Approval: 1988Royal Pharmaceuticals | HILL DERMACEUTICALS, INC.20250509
b81fdd0d-ca8e-4e48-a9e1-b2472272ef2bNational Council for Prescription Drug Programs20120724

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
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD18394
CODESNDANDA019452
CODESRxCUI1191301
CODESSPL_SET_IDeb00f222-8105-4e05-90e8-bbd129784364
NAMESPrescribable SynonymDermOtic Oil 0.01 % Otic Solution
NAMESRXNAV_STRDermotic 0.1 MG/ML Otic Solution
NAMESRxNorm Namefluocinolone acetonide 0.1 MG/ML Otic Solution [Dermotic]
NAMESRxNorm SynonymDermotic 0.1 MG/ML Otic Solution
NAMESRxNorm SynonymDermotic Oil 0.01 % (fluocinolone acetonide 0.11 MG/GM) Otic Solution
NAMESRxNorm SynonymDermotic Oil 0.01 % Otic Solution
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon