Fluocinolone Acetonide Topical Solution USP, 0.01%

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Fluocinolone Acetonide Topical Solution USP, 0.01%
Generic name: FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%
Manufacturer: Encube Ethicals, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36
SPL ID: 2a5cbd76-85fe-4c9c-89b9-7c5924c82c6f
Version: 6
Effective date: 2026-03-18
Source export date: 2026-10-12
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:32:07

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	209913	derived:openfda.application_number
application number		ANDA209913	openfda.application_number
brand name		Fluocinolone Acetonide Topical Solution USP, 0.01%	openfda.brand_name
generic name		FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%	openfda.generic_name
manufacturer name		Encube Ethicals, Inc.	openfda.manufacturer_name
ndc	package	21922-003-01	openfda.package_ndc
ndc	product	21922-003	openfda.product_ndc
ndc11	package	21922000301	derived:openfda.package_ndc
rxcui		1191310	openfda.rxcui
spl id		2a5cbd76-85fe-4c9c-89b9-7c5924c82c6f	id
spl set id		3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36	set_id
unii		0CD5FD6S2M	openfda.unii

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 2 matching rows.

adverse reactions

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Perioral dermatitis Itching Allergic contact dermatitis Irritation Maceration of the skin Dryness Secondary infection Folliculitis Skin atrophy Hypertrichosis Striae Acneiform eruptions Miliaria Hypopigmentation

adverse reactions table

<table styleCode="Noautorules" width="100%"><col width="50%" align="left" valign="middle"/><col width="50%" align="left" valign="middle"/><thead align="center"><tr><th>Burning</th><th>Perioral dermatitis</th></tr></thead><tbody><tr><td valign="top"><paragraph>Itching</paragraph></td><td valign="top"><paragraph>Allergic contact dermatitis</paragraph></td></tr><tr><td valign="top"><paragraph>Irritation</paragraph></td><td valign="top"><paragraph>Maceration of the skin</paragraph></td></tr><tr><td valign="top"><paragraph>Dryness</paragraph></td><td valign="top"><paragraph>Secondary infection</paragraph></td></tr><tr><td valign="top"><paragraph>Folliculitis</paragraph></td><td valign="top"><paragraph>Skin atrophy</paragraph></td></tr><tr><td valign="top"><paragraph>Hypertrichosis</paragraph></td><td valign="top"><paragraph>Striae</paragraph></td></tr><tr><td valign="top"><paragraph>Acneiform eruptions</paragraph></td><td valign="top"><paragraph>Miliaria</paragraph></td></tr><tr><td valign="top"><paragraph>Hypopigmentation</paragraph></td><td valign="top"><paragraph> </paragraph></td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.