FDA.reportPublic FDA data

DERMOTIC

Product NDC
68791-103
11-digit product format
687910103
Labeler code
68791
Product ID
68791-103_195c48d9-bb7a-4c89-b6b8-35fff5aefff8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
OIL
Route
AURICULAR (OTIC)
Labeler
Royal Pharmaceuticals
Application
NDA019452
Marketing category
NDA
Marketing start
2005-11-09
Substance
FLUOCINOLONE ACETONIDE
Active strength
.11 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DERMOTIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINOLONE ACETONIDE.11 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M
Rxcui1191299, 1191301

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
7df2570a-c555-4d82-9189-9247c722b62cProduct name120150402
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
a78a3633-fd06-b0af-63b3-c714de3b3bfaProduct name120140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68791-103-202024-02-02C16284748780-11030e365-2cd6-111a-e063-dadaa90a10e2These 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: 1988
68791-103-202024-01-30C16284748780-11030e365-2cd6-111a-e063-dadaa90a10e2These 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: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68791-103-20DERMOTIC1 in 1 CARTONOIL114
68791-103-20DERMOTIC20 mL in 1 BOTTLE, DROPPEROIL2014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68791-103-20ML - Milliliter68791-103c16747ea-4ed3-4043-88cb-3d88959c9d3012013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fluocinolone acetonideACTIVE INGREDIENT0CD5FD6S2MDERMOTIC (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]3
fluocinolone acetonideACTIVE MOIETY0CD5FD6S2MDERMOTIC (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DERMOTIC (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]3
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSDERMOTIC (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]3
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPDERMOTIC (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]3
OLETH-2INACTIVE INGREDIENT7L6R1SQ6M0DERMOTIC (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]3
PEANUT OILINACTIVE INGREDIENT5TL50QU0W4DERMOTIC (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68791-103DERMOTIC (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]14Current NDC, Legacy NDC, 2 package rows20250511_eb00f222-8105-4e05-90e8-bbd129784364.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191301DermOtic Oil 0.01 % Otic SolutionPSNeb00f222-8105-4e05-90e8-bbd12978436414
1191299fluocinolone acetonide 0.01 % Oil for Otic SolutionPSNeb00f222-8105-4e05-90e8-bbd12978436414
1191301fluocinolone acetonide 0.1 MG/ML Otic Solution [Dermotic]SBDeb00f222-8105-4e05-90e8-bbd12978436414
1191299fluocinolone acetonide 0.1 MG/ML Otic SolutionSCDeb00f222-8105-4e05-90e8-bbd12978436414
1191301Dermotic 0.1 MG/ML Otic SolutionSYeb00f222-8105-4e05-90e8-bbd12978436414
1191301Dermotic Oil 0.01 % (fluocinolone acetonide 0.11 MG/GM) Otic SolutionSYeb00f222-8105-4e05-90e8-bbd12978436414
1191301Dermotic Oil 0.01 % Otic SolutionSYeb00f222-8105-4e05-90e8-bbd12978436414
1191299fluocinolone acetonide 0.01 % Auricular OilSYeb00f222-8105-4e05-90e8-bbd12978436414
1191299fluocinolone acetonide 0.01 % Oil for Otic SolutionSYeb00f222-8105-4e05-90e8-bbd12978436414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68791-103-20687910103201 BOTTLE, DROPPER in 1 CARTON (68791-103-20) / 20 mL in 1 BOTTLE, DROPPER2005-11-090000-00-00NoNoCurrent