Home RxNorm 1191310 fluocinolone acetonide 0.1 MG/ML Topical Solution 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 1191310
RxNorm name fluocinolone acetonide 0.1 MG/ML Topical Solution
Display name Fluocinolone (Topical)
Full name fluocinolone acetonide 0.1 MG/ML Topical Solution
Term type SCD
Status Active
Strength 0.01%
Dose form Sol
Route Topical
Updated 2026-07-18 07:00:12 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 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 0168-0059-60 0168-0059 Fluocinolone Acetonide fluocinolone acetonide Fougera Pharmaceuticals, LLC ANDA088167 0591-2990-60 0591-2990 Fluocinolone Acetonide Topical Fluocinolone Acetonide Topical Actavis Pharma, Inc. ANDA208386 21922-003-01 21922-003 Fluocinolone Acetonide Topical Solution USP, 0.01% Fluocinolone Acetonide Topical Solution USP, 0.01% Encube Ethicals, Inc. ANDA209913 43386-069-60 43386-069 Fluocinolone Acetonide Fluocinolone Acetonide Lupin Pharmaceuticals,Inc. ANDA206422 51672-1365-2 51672-1365 Fluocinolone Acetonide fluocinolone acetonide Sun Pharmaceutical Industries, Inc. ANDA089124 51672-1365-4 51672-1365 Fluocinolone Acetonide fluocinolone acetonide Sun Pharmaceutical Industries, Inc. ANDA089124 63629-9584-1 63629-9584 Fluocinolone Acetonide Topical Solution USP, 0.01% Fluocinolone Acetonide Topical Solution USP, 0.01% Bryant Ranch Prepack ANDA209913 72162-1271-6 72162-1271 Fluocinolone Acetonide Topical Solution USP, 0.01% Fluocinolone Acetonide Topical Solution USP, 0.01% Bryant Ranch Prepack ANDA209913
Drugs@FDA Applications# Application, NDC, Name table Application NDC Name Marketing category Labeler ANDA088167 0168-0059 Fluocinolone Acetonide fluocinolone acetonide ANDA Fougera Pharmaceuticals, LLC ANDA208386 0591-2990 Fluocinolone Acetonide Topical Fluocinolone Acetonide Topical ANDA Actavis Pharma, Inc. ANDA209913 21922-003 Fluocinolone Acetonide Topical Solution USP, 0.01% Fluocinolone Acetonide Topical Solution USP, 0.01% ANDA Encube Ethicals, Inc. ANDA206422 43386-069 Fluocinolone Acetonide Fluocinolone Acetonide ANDA Lupin Pharmaceuticals,Inc. ANDA089124 51672-1365 Fluocinolone Acetonide fluocinolone acetonide ANDA Sun Pharmaceutical Industries, Inc.
RxNav Current And Historical NDCs# RxNav current and historical NDC rows page 1 of 1 · 70 matching rows.
NDC11, Source, Active table NDC11 Source Active 00168005960 rxnav_ndcs yes 00591299060 rxnav_ndcs yes 00713032553 rxnav_ndcs yes 10135067061 rxnav_ndcs yes 21922000301 rxnav_ndcs yes 43386006960 rxnav_ndcs yes 51672136502 rxnav_ndcs yes 51672136504 rxnav_ndcs yes 52565001259 rxnav_ndcs yes 63629958401 rxnav_ndcs yes 71428000260 rxnav_ndcs yes 72162127106 rxnav_ndcs yes 00023087820 rxnav_historical_indirect 00023087860 rxnav_historical_indirect 00033250602 rxnav_historical_indirect 00033250644 rxnav_historical_indirect 00033250646 rxnav_historical_indirect 00033250674 rxnav_historical_indirect 00182156465 rxnav_historical_indirect 00182156468 rxnav_historical 00223618020 rxnav_historical_indirect 00223618060 rxnav_historical_indirect 00364734355 rxnav_historical_indirect 00364734358 rxnav_historical_indirect 00462005960 rxnav_historical_indirect 00472115802 rxnav_historical_indirect 00536072061 rxnav_historical_indirect 00536072073 rxnav_historical_indirect 00570115802 rxnav_historical_indirect 00570115820 rxnav_historical_indirect 00603123143 rxnav_historical 00603123149 rxnav_historical 00677079022 rxnav_historical_indirect 00677079025 rxnav_historical_indirect 00686005960 rxnav_historical_indirect 00701049120 rxnav_historical_indirect 00701049160 rxnav_historical_indirect 00719438074 rxnav_historical_indirect 00719438088 rxnav_historical_indirect 00781630461 rxnav_historical_indirect 00781630480 rxnav_historical_indirect 00814319574 rxnav_historical_indirect 00832849120 rxnav_historical_indirect 00832849160 rxnav_historical_indirect 00904266036 rxnav_historical 00904266103 rxnav_historical 00904266155 rxnav_historical_indirect 13411046906 rxnav_historical 24208046563 rxnav_historical 24208046567 rxnav_historical 25463005960 rxnav_historical 49158020932 rxnav_historical_indirect 49158020940 rxnav_historical_indirect 51432058909 rxnav_historical_indirect 51432058917 rxnav_historical_indirect 52446091543 rxnav_historical_indirect 52446091549 rxnav_historical_indirect 52493037520 rxnav_historical_indirect 54569339300 rxnav_historical 54868226400 rxnav_historical 54868226401 rxnav_historical 55045209007 rxnav_historical 58016478701 rxnav_historical 58118990606 rxnav_historical 63285050644 rxnav_historical_indirect 63285050646 rxnav_historical_indirect 99207050644 rxnav_historical_indirect 99207050646 rxnav_historical_indirect 99207250644 rxnav_historical_indirect 99207250646 rxnav_historical_indirect
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 · 7 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fluocinolone Acetonide Topical Solution USP, 0.01% FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% Encube Ethicals, Inc. 3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36 2026-03-18 Adverse reactions Exact identifier ndc (package): 21922-003-01 ndc (product): 21922-003 ndc11 (package): 21922000301 rxcui: 1191310 Fluocinolone Acetonide Topical Solution USP, 0.01% FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% Bryant Ranch Prepack 3fa4d5db-b17f-44dc-aa6a-50934d42c68d 2026-02-18 Adverse reactions Exact identifier ndc (package): 72162-1271-6 ndc (product): 72162-1271 ndc11 (package): 72162127106 rxcui: 1191310 Fluocinolone Acetonide FLUOCINOLONE ACETONIDE Fougera Pharmaceuticals, LLC 5649e15a-6a7c-4752-ac28-01e453afb37e 2026-01-28 Adverse reactions Exact identifier ndc (package): 0168-0059-60 ndc (product): 0168-0059 ndc11 (package): 00168005960 rxcui: 1191310 Fluocinolone Acetonide FLUOCINOLONE ACETONIDE Sun Pharmaceutical Industries, Inc. 02352ed1-3568-441f-add8-45201351a11c 2025-07-03 Adverse reactions Exact identifier ndc (package): 51672-1365-4 ndc (package): 51672-1365-2 ndc (product): 51672-1365 ndc11 (package): 51672136504 ndc11 (package): 51672136502 rxcui: 1191310 Fluocinolone Acetonide Topical Solution USP, 0.01% FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% Bryant Ranch Prepack ce89966d-d7ea-4986-936e-6d46aee497cd 2024-08-20 Adverse reactions Exact identifier ndc (package): 63629-9584-1 ndc (product): 63629-9584 ndc11 (package): 63629958401 rxcui: 1191310 Fluocinolone Acetonide FLUOCINOLONE ACETONIDE Lupin Pharmaceuticals,Inc. 460f5a55-6437-4651-bc08-8063ca579c8d 2019-02-21 Adverse reactions Exact identifier ndc (package): 43386-069-60 ndc (product): 43386-069 ndc11 (package): 43386006960 rxcui: 1191310 Fluocinolone Acetonide Topical FLUOCINOLONE ACETONIDE TOPICAL Actavis Pharma, Inc. 98dfd7a4-2208-4637-acf5-080a5813a433 2016-08-01 Adverse reactions Exact identifier ndc (package): 0591-2990-60 ndc (product): 0591-2990 ndc11 (package): 00591299060 rxcui: 1191310
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 · 12 matching rows.
Set ID, RxNorm mappings, Terms table Set ID RxNorm mappings Terms SPL version Label Effective ce89966d-d7ea-4986-936e-6d46aee497cd fluocinolone acetonide 0.01 % Topical Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Topical Solution [SCD] · fluocinolone acetonide 0.01 % Topical Solution [SY] 3 104 Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only 20240820 3fa4d5db-b17f-44dc-aa6a-50934d42c68d fluocinolone acetonide 0.01 % Topical Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Topical Solution [SCD] · fluocinolone acetonide 0.01 % Topical Solution [SY] 3 102 Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only 20260218 98dfd7a4-2208-4637-acf5-080a5813a433 fluocinolone acetonide 0.01 % Topical Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Topical Solution [SCD] · fluocinolone acetonide 0.01 % Topical Solution [SY] 3 12 FLUOCINOLONE ACETONIDE TOPICAL SOLUTION, USP 0.01% Rx Only 20160801 5649e15a-6a7c-4752-ac28-01e453afb37e fluocinolone acetonide 0.01 % Topical Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Topical Solution [SCD] · fluocinolone acetonide 0.01 % Topical Solution [SY] 3 10 FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% 20260128 3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36 fluocinolone acetonide 0.01 % Topical Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Topical Solution [SCD] · fluocinolone acetonide 0.01 % Topical Solution [SY] 3 6 Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only 20260318 460f5a55-6437-4651-bc08-8063ca579c8d fluocinolone acetonide 0.01 % Topical Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Topical Solution [SCD] · fluocinolone acetonide 0.01 % Topical Solution [SY] 3 5 Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only 20190221 b859bc63-a9e3-4a6d-a3f7-711b4eeaba63 fluocinolone acetonide 0.01 % Topical Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Topical Solution [SCD] · fluocinolone acetonide 0.01 % Topical Solution [SY] 3 5 Fluocinolone Acetonide Topical Solution USP, 0.01% 20121207 7105ba2c-4159-465e-9f2d-6ebfd13fc8bd fluocinolone acetonide 0.01 % Topical Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Topical Solution [SCD] · fluocinolone acetonide 0.01 % Topical Solution [SY] 3 4 Fluocinolone Acetonide 20221103 02352ed1-3568-441f-add8-45201351a11c fluocinolone acetonide 0.01 % Topical Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Topical Solution [SCD] · fluocinolone acetonide 0.01 % Topical Solution [SY] 3 3 Fluocinolone Acetonide Topical Solution USP, 0.01% 20250703 136cb37e-e939-40b5-9725-194b14a9b090 fluocinolone acetonide 0.01 % Topical Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Topical Solution [SCD] · fluocinolone acetonide 0.01 % Topical Solution [SY] 3 2 NOXIPAK KIT 20171108 f1b8a26a-dc63-4701-8a78-cc1f99fca1b3 fluocinolone acetonide 0.01 % Topical Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Topical Solution [SCD] · fluocinolone acetonide 0.01 % Topical Solution [SY] 3 1 XILAPAK KIT 20171102 372a6a06-c9de-48d5-ad02-c4004038f85e fluocinolone acetonide 0.01 % Topical Solution [PSN] · fluocinolone acetonide 0.1 MG/ML Topical Solution [SCD] · fluocinolone acetonide 0.01 % Topical Solution [SY] 3 1 FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% 20091110
Recently Linked DailyMed Labels# Set ID, Title, Manufacturer table Set ID Title Manufacturer Effective 3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36 Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only Encube Ethicals, Inc. | Encube Ethicals Private Limited 20260318 3fa4d5db-b17f-44dc-aa6a-50934d42c68d Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only Bryant Ranch Prepack 20260218 5649e15a-6a7c-4752-ac28-01e453afb37e FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% Fougera Pharmaceuticals, LLC 20260128 02352ed1-3568-441f-add8-45201351a11c Fluocinolone Acetonide Topical Solution USP, 0.01% Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc. 20250703 ce89966d-d7ea-4986-936e-6d46aee497cd Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only Bryant Ranch Prepack 20240820 270961cf-7ccb-4291-be16-87ce3196b200 Fluocinolone Acetonide Topical Solution USP, 0.01% Glasshouse Pharmaceuticals Limited Canada 20240109 7105ba2c-4159-465e-9f2d-6ebfd13fc8bd Fluocinolone Acetonide Marlex Pharmaceuticals Inc 20221103 ab896e60-144a-a876-f968-7ff88267d6d8 Fluocinolone Acetonide Topical Solution, USP 0.01% For Topical Use Only Not For Ophthalmic Use Rx Only Cosette Pharmaceuticals, Inc. 20191225 460f5a55-6437-4651-bc08-8063ca579c8d Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only Lupin Pharmaceuticals,Inc. | Lupin Inc. | Novel Laboratories, Inc. 20190221 136cb37e-e939-40b5-9725-194b14a9b090 NOXIPAK KIT SOLUTECH PHARMACEUTICALS LLC 20171108 f1b8a26a-dc63-4701-8a78-cc1f99fca1b3 XILAPAK KIT SOLUTECH PHARMACEUTICALS LLC 20171102 98dfd7a4-2208-4637-acf5-080a5813a433 FLUOCINOLONE ACETONIDE TOPICAL SOLUTION, USP 0.01% Rx Only Actavis Pharma, Inc. 20160801 e73c8061-3edf-4c0e-93f3-e4144c8853bc National Council for Prescription Drug Programs 20130213 b859bc63-a9e3-4a6d-a3f7-711b4eeaba63 Fluocinolone Acetonide Topical Solution USP, 0.01% Teligent Pharma, Inc. 20121207 c7409cfa-1517-4aba-88cc-19efbc50f41a National Council for Prescription Drug Programs 20120724 67e9f25f-126d-44e6-ad4f-ef49068f4141 National Council for Prescription Drug Programs 20120724 372a6a06-c9de-48d5-ad02-c4004038f85e FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% Physicians Total Care, Inc. 20091110
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 ANDA ANDA088167 CODES ANDA ANDA089124 CODES ANDA ANDA206422 CODES ANDA ANDA208386 CODES ANDA ANDA209913 CODES SNOMEDCT 374493003 CODES VUID 4004176 NAMES Prescribable Synonym fluocinolone acetonide 0.01 % Topical Solution SOURCES Source Gold Standard Alchemy SOURCES Source Metathesaurus FDA Structured Product Labels SOURCES Source Micromedex RED BOOK SOURCES Source Multum MediSource Lexicon SOURCES Source National Drug Data File Plus Source Vocabulary SOURCES Source US Edition of SNOMED_CT SOURCES Source Veterans Health Administration National Drug File