Home RxNorm 2045201 fluocinolone acetonide 0.1 MG/ML Otic Solution [Flac] 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 2045201
RxNorm name fluocinolone acetonide 0.1 MG/ML Otic Solution [Flac]
Display name FLAC (Otic)
Full name fluocinolone acetonide 0.1 MG/ML Otic Solution [Flac]
Term type SBD
Status Active
Strength 0.01%
Dose form Sol
Route Otic
Updated 2026-11-06 11:40:19 RxNorm Status History#
Status Active
Source RXNORM
Current YES
Release start 062018
Active start 062018
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 39328-079-20 39328-079 Flac Otic Oil fluocinolone acetonide Patrin Pharma, Inc. ANDA210736
Drugs@FDA Applications# Application, NDC, Name table Application NDC Name Marketing category Labeler ANDA210736 39328-079 Flac Otic Oil fluocinolone acetonide ANDA Patrin Pharma, Inc.
RxNav Current And Historical NDCs# RxNav current and historical NDC rows page 1 of 1 · 1 matching rows.
NDC11, Source, Active table NDC11 Source Active 39328007920 rxnav_ndcs yes
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb Flac 0.01 % Otic Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Otic Solution [Flac] [SBD] · Flac 0.01 % Otic Solution [SY] · Flac 0.1 MG/ML Otic Solution [SY] 4 6 Flac ® Otic Oil (fluocinolone acetonide oil, 0.01%) Ear Drops 20241119
Recently Linked DailyMed Labels# Set ID, Title, Manufacturer table Set ID Title Manufacturer Effective 4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb Flac ® Otic Oil (fluocinolone acetonide oil, 0.01%) Ear Drops Patrin Pharma, Inc. 20241119
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 CODES ANDA ANDA210736 NAMES Prescribable Synonym Flac 0.01 % Otic Solution SOURCES Source Gold Standard Alchemy SOURCES Source Metathesaurus FDA Structured Product Labels