Home RxNorm 1191301 fluocinolone acetonide 0.1 MG/ML Otic Solution [Dermotic] Drug identity information. FDA.report links public drug records from RxNav, DailyMed, FDA NDC, Drugs@FDA, and related public sources where available. This page is informational only and is not medical, prescribing, or regulatory advice.
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 Ingredient Strength Base Basis of strength fluocinolone acetonide 0.1 MG / 1 ML fluocinolone fluocinolone acetonide
Derived Ingredient Concepts# FDA NDC Products And Packages# Package NDC, Product NDC, Name table Package NDC Product NDC Name Labeler Application 68791-103-20 68791-103 DERMOTIC fluocinolone acetonide Royal Pharmaceuticals NDA019452
Drugs@FDA Applications# Application, NDC, Name table Application NDC Name Marketing category Labeler NDA019452 68791-103 DERMOTIC fluocinolone acetonide NDA Royal Pharmaceuticals
RxNav Current And Historical NDCs# RxNav current and historical NDC rows page 1 of 1 · 3 matching rows.
NDC11, Source, Active table NDC11 Source Active 68791010320 rxnav_ndcs yes 28105016020 rxnav_historical 54868611900 rxnav_historical
UNII Substances# UNII substance links page 1 of 1 · 0 matching rows.
No records found.
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Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.
Set ID, RxNorm mappings, Terms table Set ID RxNorm mappings Terms SPL version Label Effective eb00f222-8105-4e05-90e8-bbd129784364 DermOtic Oil 0.01 % Otic Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Otic Solution [Dermotic] [SBD] · Dermotic 0.1 MG/ML Otic Solution [SY] · Dermotic Oil 0.01 % (fluocinolone acetonide 0.11 MG/GM) Otic Solution [SY] · Dermotic Oil 0.01 % Otic Solution [SY] 5 14 These 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 20250509
Recently Linked DailyMed Labels# Set ID, Title, Manufacturer table Set ID Title Manufacturer Effective eb00f222-8105-4e05-90e8-bbd129784364 These 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 Royal Pharmaceuticals | HILL DERMACEUTICALS, INC. 20250509 b81fdd0d-ca8e-4e48-a9e1-b2472272ef2b National Council for Prescription Drug Programs 20120724
Properties# Category, Property, Value table Category Property Value ATTRIBUTES AVAILABLE_STRENGTH 0.1 MG/ML ATTRIBUTES GENERAL_CARDINALITY SINGLE ATTRIBUTES HUMAN_DRUG US ATTRIBUTES RXNAV_HUMAN_DRUG US ATTRIBUTES SCHEDULE 0 CODES NDA NDA019452 NAMES Prescribable Synonym DermOtic Oil 0.01 % Otic Solution SOURCES Source Gold Standard Alchemy SOURCES Source Metathesaurus FDA Structured Product Labels SOURCES Source Micromedex RED BOOK SOURCES Source Multum MediSource Lexicon