FDA.reportPublic FDA data

fluocinolone acetonide 0.1 MG/ML Otic Solution

RxCUI
1191299
RxNorm name
fluocinolone acetonide 0.1 MG/ML Otic Solution
Display name
Fluocinolone (Otic)
Full name
fluocinolone acetonide 0.1 MG/ML Otic Solution
Term type
SCD
Status
Active
Strength
0.01%
Dose form
Sol
Route
Otic
Updated
2026-07-18 06:59:57

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
Otic Solution316973

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 Otic SolutionNAMES
RxNorm Namefluocinolone acetonide 0.1 MG/ML Otic SolutionNAMES
RxNorm Synonymfluocinolone acetonide 0.01 % Auricular OilNAMES
RxNorm Synonymfluocinolone acetonide 0.01 % Oil for Otic SolutionNAMES
TTYSCDATTRIBUTES
SPL_SET_ID2bcea813-d629-42c5-8953-fa231b4cbf58CODES
SPL_SET_ID7954bdec-1b75-41d1-8c19-500eceaf6655CODES
SPL_SET_ID79591576-1eab-48c5-b0a6-e205b3cc097eCODES
SPL_SET_IDa00224b0-3db5-4d40-b370-5ec5476e1e10CODES
SPL_SET_IDe6af2549-50b5-4b7f-a0c0-de0f7626b6f3CODES
SPL_SET_IDf7861aba-f199-4fe4-90cc-bebea55b3b5fCODES
RxCUI1191299CODES
MMSL_CODEBD18394CODES
MMSL_CODECD18394CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
45802-009-1045802-009Fluocinolone Acetonide Fluocinolone AcetonidePadagis Israel Pharmaceuticals LtdANDA202849
64980-329-2064980-329Fluocinolone Acetonide Fluocinolone AcetonideRising Pharma Holdings, Inc.ANDA203378
68462-185-5668462-185fluocinolone acetonide fluocinolone acetonideGlenmark Pharmaceuticals Inc., USAANDA211815
70752-159-2070752-159FLUOCINOLONE ACETONIDE fluocinolone acetonideQuagen Pharmaceuticals LLCANDA212762
71335-2879-171335-2879FLUOCINOLONE ACETONIDE fluocinolone acetonideBryant Ranch PrepackANDA212762
72162-2320-272162-2320FLUOCINOLONE ACETONIDE fluocinolone acetonideBryant Ranch PrepackANDA212762

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA20284945802-009Fluocinolone Acetonide Fluocinolone AcetonideANDAPadagis Israel Pharmaceuticals Ltd
ANDA20337864980-329Fluocinolone Acetonide Fluocinolone AcetonideANDARising Pharma Holdings, Inc.
ANDA21181568462-185fluocinolone acetonide fluocinolone acetonideANDAGlenmark Pharmaceuticals Inc., USA
ANDA21276270752-159FLUOCINOLONE ACETONIDE fluocinolone acetonideANDAQuagen Pharmaceuticals LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
13925050820rxnav_ndcsyes
45802000910rxnav_ndcsyes
64980032920rxnav_ndcsyes
65162070294rxnav_ndcsyes
68462018556rxnav_ndcsyes
70752015920rxnav_ndcsyes
71335287901rxnav_ndcsyes
72162232002rxnav_ndcsyes
00374511001rxnav_historical
42291028320rxnav_historical
58118994902rxnav_historical
61748025020rxnav_historical
72641000220rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
7954bdec-1b75-41d1-8c19-500eceaf6655fluocinolone acetonide 0.01 % Auricular OilSY102Fluocinolone Acetonide Oil, 0.01% (Ear Drops)20241108
7954bdec-1b75-41d1-8c19-500eceaf6655fluocinolone acetonide 0.01 % Oil for Otic SolutionPSN102Fluocinolone Acetonide Oil, 0.01% (Ear Drops)20241108
7954bdec-1b75-41d1-8c19-500eceaf6655fluocinolone acetonide 0.01 % Oil for Otic SolutionSY102Fluocinolone Acetonide Oil, 0.01% (Ear Drops)20241108
7954bdec-1b75-41d1-8c19-500eceaf6655fluocinolone acetonide 0.1 MG/ML Otic SolutionSCD102Fluocinolone Acetonide Oil, 0.01% (Ear Drops)20241108
f7861aba-f199-4fe4-90cc-bebea55b3b5ffluocinolone acetonide 0.1 MG/ML Otic SolutionSCD100Fluocinolone Acetonide Oil, 0.01% (Ear Drops)20251111
f7861aba-f199-4fe4-90cc-bebea55b3b5ffluocinolone acetonide 0.01 % Oil for Otic SolutionPSN100Fluocinolone Acetonide Oil, 0.01% (Ear Drops)20251111
f7861aba-f199-4fe4-90cc-bebea55b3b5ffluocinolone acetonide 0.01 % Auricular OilSY100Fluocinolone Acetonide Oil, 0.01% (Ear Drops)20251111
f7861aba-f199-4fe4-90cc-bebea55b3b5ffluocinolone acetonide 0.01 % Oil for Otic SolutionSY100Fluocinolone Acetonide Oil, 0.01% (Ear Drops)20251111
eb00f222-8105-4e05-90e8-bbd129784364fluocinolone acetonide 0.01 % Oil for 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 SolutionSCD14These 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 0.01 % Oil for 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-bbd129784364fluocinolone acetonide 0.01 % Auricular OilSY14These 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
79591576-1eab-48c5-b0a6-e205b3cc097efluocinolone acetonide 0.01 % Oil for Otic SolutionPSN9These highlights do not include all the information needed to use FLUOCINOLONE ACETONIDE OIL safely and effectively. See full prescribing information for FLUOCINOLONE ACETONIDE OIL. FLUOCINOLONE ACETONIDE OIL (ear drops), for otic use Initial U.S. Approval: 198820260309
79591576-1eab-48c5-b0a6-e205b3cc097efluocinolone acetonide 0.1 MG/ML Otic SolutionSCD9These highlights do not include all the information needed to use FLUOCINOLONE ACETONIDE OIL safely and effectively. See full prescribing information for FLUOCINOLONE ACETONIDE OIL. FLUOCINOLONE ACETONIDE OIL (ear drops), for otic use Initial U.S. Approval: 198820260309
79591576-1eab-48c5-b0a6-e205b3cc097efluocinolone acetonide 0.01 % Oil for Otic SolutionSY9These highlights do not include all the information needed to use FLUOCINOLONE ACETONIDE OIL safely and effectively. See full prescribing information for FLUOCINOLONE ACETONIDE OIL. FLUOCINOLONE ACETONIDE OIL (ear drops), for otic use Initial U.S. Approval: 198820260309
79591576-1eab-48c5-b0a6-e205b3cc097efluocinolone acetonide 0.01 % Auricular OilSY9These highlights do not include all the information needed to use FLUOCINOLONE ACETONIDE OIL safely and effectively. See full prescribing information for FLUOCINOLONE ACETONIDE OIL. FLUOCINOLONE ACETONIDE OIL (ear drops), for otic use Initial U.S. Approval: 198820260309
e6af2549-50b5-4b7f-a0c0-de0f7626b6f3fluocinolone acetonide 0.01 % Oil for Otic SolutionPSN8These highlights do not include all the information needed to use FLUOCINOLONE ACETONIDE OIL safely and effectively. See full prescribing information for FLUOCINOLONE ACETONIDE OIL. FLUOCINOLONE ACETONIDE oil (ear drops), for otic use Initial U.S. Approval: 198820250731
e6af2549-50b5-4b7f-a0c0-de0f7626b6f3fluocinolone acetonide 0.01 % Auricular OilSY8These highlights do not include all the information needed to use FLUOCINOLONE ACETONIDE OIL safely and effectively. See full prescribing information for FLUOCINOLONE ACETONIDE OIL. FLUOCINOLONE ACETONIDE oil (ear drops), for otic use Initial U.S. Approval: 198820250731
e6af2549-50b5-4b7f-a0c0-de0f7626b6f3fluocinolone acetonide 0.01 % Oil for Otic SolutionSY8These highlights do not include all the information needed to use FLUOCINOLONE ACETONIDE OIL safely and effectively. See full prescribing information for FLUOCINOLONE ACETONIDE OIL. FLUOCINOLONE ACETONIDE oil (ear drops), for otic use Initial U.S. Approval: 198820250731
e6af2549-50b5-4b7f-a0c0-de0f7626b6f3fluocinolone acetonide 0.1 MG/ML Otic SolutionSCD8These highlights do not include all the information needed to use FLUOCINOLONE ACETONIDE OIL safely and effectively. See full prescribing information for FLUOCINOLONE ACETONIDE OIL. FLUOCINOLONE ACETONIDE oil (ear drops), for otic use Initial U.S. Approval: 198820250731
4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbbfluocinolone acetonide 0.1 MG/ML Otic SolutionSCD6Flac ® Otic Oil (fluocinolone acetonide oil, 0.01%) Ear Drops20241119
4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbbfluocinolone acetonide 0.01 % Oil for Otic SolutionPSN6Flac ® Otic Oil (fluocinolone acetonide oil, 0.01%) Ear Drops20241119
4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbbfluocinolone acetonide 0.01 % Auricular OilSY6Flac ® Otic Oil (fluocinolone acetonide oil, 0.01%) Ear Drops20241119
4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbbfluocinolone acetonide 0.01 % Oil for Otic SolutionSY6Flac ® Otic Oil (fluocinolone acetonide oil, 0.01%) Ear Drops20241119
2bcea813-d629-42c5-8953-fa231b4cbf58fluocinolone acetonide 0.01 % Auricular OilSY6Fluocinolone Acetonide Oil, 0.01% (Ear Drops)20230226
2bcea813-d629-42c5-8953-fa231b4cbf58fluocinolone acetonide 0.01 % Oil for Otic SolutionSY6Fluocinolone Acetonide Oil, 0.01% (Ear Drops)20230226
2bcea813-d629-42c5-8953-fa231b4cbf58fluocinolone acetonide 0.01 % Oil for Otic SolutionPSN6Fluocinolone Acetonide Oil, 0.01% (Ear Drops)20230226
2bcea813-d629-42c5-8953-fa231b4cbf58fluocinolone acetonide 0.1 MG/ML Otic SolutionSCD6Fluocinolone Acetonide Oil, 0.01% (Ear Drops)20230226
a00224b0-3db5-4d40-b370-5ec5476e1e10fluocinolone acetonide 0.01 % Oil for Otic SolutionSY2Fluocinolone Acetonide Oil, 0.01% (Ear Drops) Rx only20181218
a00224b0-3db5-4d40-b370-5ec5476e1e10fluocinolone acetonide 0.1 MG/ML Otic SolutionSCD2Fluocinolone Acetonide Oil, 0.01% (Ear Drops) Rx only20181218
a00224b0-3db5-4d40-b370-5ec5476e1e10fluocinolone acetonide 0.01 % Auricular OilSY2Fluocinolone Acetonide Oil, 0.01% (Ear Drops) Rx only20181218
a00224b0-3db5-4d40-b370-5ec5476e1e10fluocinolone acetonide 0.01 % Oil for Otic SolutionPSN2Fluocinolone Acetonide Oil, 0.01% (Ear Drops) Rx only20181218

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
79591576-1eab-48c5-b0a6-e205b3cc097eThese highlights do not include all the information needed to use FLUOCINOLONE ACETONIDE OIL safely and effectively. See full prescribing information for FLUOCINOLONE ACETONIDE OIL. FLUOCINOLONE ACETONIDE OIL (ear drops), for otic use Initial U.S. Approval: 1988Rising Pharma Holdings, Inc. | Lyne Laboratories, Inc.20260309
f7861aba-f199-4fe4-90cc-bebea55b3b5fFluocinolone Acetonide Oil, 0.01% (Ear Drops)Bryant Ranch Prepack20251111
79591576-1eab-48c5-b0a6-e205b3cc097eThese highlights do not include all the information needed to use FLUOCINOLONE ACETONIDE OIL safely and effectively. See full prescribing information for FLUOCINOLONE ACETONIDE OIL. FLUOCINOLONE ACETONIDE OIL (ear drops), for otic use Initial U.S. Approval: 1988Rising Pharma Holdings, Inc. | Lyne Laboratories, Inc.20250825
e6af2549-50b5-4b7f-a0c0-de0f7626b6f3These highlights do not include all the information needed to use FLUOCINOLONE ACETONIDE OIL safely and effectively. See full prescribing information for FLUOCINOLONE ACETONIDE OIL. FLUOCINOLONE ACETONIDE oil (ear drops), for otic use Initial U.S. Approval: 1988Padagis Israel Pharmaceuticals Ltd20250731
79591576-1eab-48c5-b0a6-e205b3cc097eFluocinolone Acetonide Oil 0.01% (Ear Drops)Rising Pharma Holdings, Inc. | Lyne Laboratories, Inc.20250417
7954bdec-1b75-41d1-8c19-500eceaf6655Fluocinolone Acetonide Oil, 0.01% (Ear Drops)Bryant Ranch Prepack20241108
2bcea813-d629-42c5-8953-fa231b4cbf58Fluocinolone Acetonide Oil, 0.01% (Ear Drops)Quagen Pharmaceuticals LLC20230226
a00224b0-3db5-4d40-b370-5ec5476e1e10Fluocinolone Acetonide Oil, 0.01% (Ear Drops) Rx onlyGlenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited20181218

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
CODESANDAANDA202849
CODESANDAANDA203378
CODESANDAANDA211815
CODESANDAANDA212762
CODESMMSL_CODEBD18394
CODESMMSL_CODECD18394
CODESRxCUI1191299
CODESSPL_SET_ID2bcea813-d629-42c5-8953-fa231b4cbf58
CODESSPL_SET_ID7954bdec-1b75-41d1-8c19-500eceaf6655
CODESSPL_SET_ID79591576-1eab-48c5-b0a6-e205b3cc097e
CODESSPL_SET_IDa00224b0-3db5-4d40-b370-5ec5476e1e10
CODESSPL_SET_IDe6af2549-50b5-4b7f-a0c0-de0f7626b6f3
CODESSPL_SET_IDf7861aba-f199-4fe4-90cc-bebea55b3b5f
CODESVUID4028602
CODESVUID4028641
NAMESPrescribable Synonymfluocinolone acetonide 0.01 % Oil for Otic Solution
NAMESRXNAV_STRfluocinolone acetonide 0.1 MG/ML Otic Solution
NAMESRxNorm Namefluocinolone acetonide 0.1 MG/ML Otic Solution
NAMESRxNorm Synonymfluocinolone acetonide 0.01 % Auricular Oil
NAMESRxNorm Synonymfluocinolone acetonide 0.01 % Oil for Otic Solution
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