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, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRfluocinolone acetonide 0.1 MG/ML Otic Solution1NAMES
RxNorm Namefluocinolone acetonide 0.1 MG/ML Otic Solution1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
6 linked values
6CODES
RxCUI11912991CODES
MMSL_CODE
2 linked values
2CODES

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#

RxNav current and historical NDC rows page 1 of 1 · 13 matching rows.

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

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluocinolone Acetonide OilFLUOCINOLONE ACETONIDERising Pharma Holdings, Inc.79591576-1eab-48c5-b0a6-e205b3cc097e2026-03-09Warnings, Adverse reactionsExact identifier
ndc (package): 64980-329-20
ndc (product): 64980-329
ndc11 (package): 64980032920
rxcui: 1191299
FLUOCINOLONE ACETONIDEFLUOCINOLONE ACETONIDEBryant Ranch Prepackf7861aba-f199-4fe4-90cc-bebea55b3b5f2025-11-11Adverse reactionsExact identifier
ndc (package): 71335-2879-1
ndc (product): 71335-2879
ndc11 (package): 71335287901
rxcui: 1191299
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEPadagis Israel Pharmaceuticals Ltde6af2549-50b5-4b7f-a0c0-de0f7626b6f32025-07-31Warnings, Adverse reactionsExact identifier
ndc (package): 45802-009-10
ndc (product): 45802-009
ndc11 (package): 45802000910
rxcui: 1191299
DERMOTICFLUOCINOLONE ACETONIDERoyal Pharmaceuticalseb00f222-8105-4e05-90e8-bbd1297843642025-05-09Warnings, Adverse reactionsExact identifier
rxcui: 1191299
Flac Otic OilFLUOCINOLONE ACETONIDEPatrin Pharma, Inc.4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb2024-11-19Adverse reactionsExact identifier
rxcui: 1191299
FLUOCINOLONE ACETONIDEFLUOCINOLONE ACETONIDEBryant Ranch Prepack7954bdec-1b75-41d1-8c19-500eceaf66552024-11-08Adverse reactionsExact identifier
ndc (package): 72162-2320-2
ndc (product): 72162-2320
ndc11 (package): 72162232002
rxcui: 1191299
FLUOCINOLONE ACETONIDEFLUOCINOLONE ACETONIDEQuagen Pharmaceuticals LLC2bcea813-d629-42c5-8953-fa231b4cbf582023-02-26Adverse reactionsExact identifier
ndc (package): 70752-159-20
ndc (product): 70752-159
ndc11 (package): 70752015920
rxcui: 1191299
fluocinolone acetonideFLUOCINOLONE ACETONIDEGlenmark Pharmaceuticals Inc., USAa00224b0-3db5-4d40-b370-5ec5476e1e102018-12-18Adverse reactionsExact identifier
ndc (package): 68462-185-56
ndc (product): 68462-185
ndc11 (package): 68462018556
rxcui: 1191299

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 8 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
7954bdec-1b75-41d1-8c19-500eceaf6655fluocinolone acetonide 0.01 % Oil for Otic Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Otic Solution [SCD] · fluocinolone acetonide 0.01 % Auricular Oil [SY] · fluocinolone acetonide 0.01 % Oil for Otic Solution [SY]4102Fluocinolone Acetonide Oil, 0.01% (Ear Drops)20241108
f7861aba-f199-4fe4-90cc-bebea55b3b5ffluocinolone acetonide 0.01 % Oil for Otic Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Otic Solution [SCD] · fluocinolone acetonide 0.01 % Auricular Oil [SY] · fluocinolone acetonide 0.01 % Oil for Otic Solution [SY]4100Fluocinolone Acetonide Oil, 0.01% (Ear Drops)20251111
eb00f222-8105-4e05-90e8-bbd129784364fluocinolone acetonide 0.01 % Oil for Otic Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Otic Solution [SCD] · fluocinolone acetonide 0.01 % Auricular Oil [SY] · fluocinolone acetonide 0.01 % Oil for Otic Solution [SY]414These 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 Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Otic Solution [SCD] · fluocinolone acetonide 0.01 % Auricular Oil [SY] · fluocinolone acetonide 0.01 % Oil for Otic Solution [SY]49These 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 Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Otic Solution [SCD] · fluocinolone acetonide 0.01 % Auricular Oil [SY] · fluocinolone acetonide 0.01 % Oil for Otic Solution [SY]48These 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 0.01 % Oil for Otic Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Otic Solution [SCD] · fluocinolone acetonide 0.01 % Auricular Oil [SY] · fluocinolone acetonide 0.01 % Oil for Otic Solution [SY]46Flac ® Otic Oil (fluocinolone acetonide oil, 0.01%) Ear Drops20241119
2bcea813-d629-42c5-8953-fa231b4cbf58fluocinolone acetonide 0.01 % Oil for Otic Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Otic Solution [SCD] · fluocinolone acetonide 0.01 % Auricular Oil [SY] · fluocinolone acetonide 0.01 % Oil for Otic Solution [SY]46Fluocinolone Acetonide Oil, 0.01% (Ear Drops)20230226
a00224b0-3db5-4d40-b370-5ec5476e1e10fluocinolone acetonide 0.01 % Oil for Otic Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Otic Solution [SCD] · fluocinolone acetonide 0.01 % Auricular Oil [SY] · fluocinolone acetonide 0.01 % Oil for Otic Solution [SY]42Fluocinolone Acetonide Oil, 0.01% (Ear Drops) Rx only20181218

Recently Linked 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
a48fba5c-815f-4d82-b8e0-20665abd7b26These highlights do not include all the information needed to use FLUOCINOLONE ACETONIDE OIL EAR DROPS safely and effectively. See full prescribing information for FLUOCINOLONE ACETONIDE OIL EAR DROPS. FLUOCINOLONE ACETONIDE OIL ear drops, for otic use Initial U.S. Approval: 1988Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLC20250805
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
be70a464-f936-4721-8cbb-b106075bfd4dFluocinolone Acetonide 0.01% Oil Ear DropsSeton Pharmaceuticals20240130
2bcea813-d629-42c5-8953-fa231b4cbf58Fluocinolone Acetonide Oil, 0.01% (Ear Drops)Quagen Pharmaceuticals LLC20230226
f3d208ca-3397-49d4-860a-772d5bb0695cFluocinolone Acetonide Oil, 0.01% (Ear Drops)Tasman Pharma Inc.20210217
a00224b0-3db5-4d40-b370-5ec5476e1e10Fluocinolone Acetonide Oil, 0.01% (Ear Drops) Rx onlyGlenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited20181218
073e8bfa-b95c-46e9-83a5-9cf1a6884514FLUOCINOLONE ACETONIDE OIL, 0.01% EAR DROPSVersaPharm Inc. - an Akorn Company | Ei LLC20181016
e589a6f5-9789-440b-be24-eeb84cc0b34cNational 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
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA202849
CODESANDAANDA203378
CODESANDAANDA211815
CODESANDAANDA212762
CODESVUID4028602
CODESVUID4028641
NAMESPrescribable 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