Fluocinonide

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: Fluocinonide
Generic name: FLUOCINONIDE
Manufacturer: Xiromed LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: d96cc4fd-abd3-1ce1-ac63-5d68a8332ecc
SPL ID: 2bfc0a7d-82bb-11d0-8ea7-c2d2a9c836ac
Version: 8
Effective date: 2020-01-13
Source export date: 2026-10-27
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/2c7d3f7bcea1543046130e07dcbaf7eea5fb0ce23f7faa6458d1c6d80c3fa0c3/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:43:43

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	212976	derived:openfda.application_number
application number		ANDA212976	openfda.application_number
brand name		Fluocinonide	openfda.brand_name
generic name		FLUOCINONIDE	openfda.generic_name
manufacturer name		Xiromed LLC	openfda.manufacturer_name
ndc	package	70700-146-16	openfda.package_ndc
ndc	package	70700-146-17	openfda.package_ndc
ndc	package	70700-146-15	openfda.package_ndc
ndc	product	70700-146	openfda.product_ndc
ndc11	package	70700014615	derived:openfda.package_ndc
ndc11	package	70700014617	derived:openfda.package_ndc
ndc11	package	70700014616	derived:openfda.package_ndc
spl id		2bfc0a7d-82bb-11d0-8ea7-c2d2a9c836ac	id
spl set id		d96cc4fd-abd3-1ce1-ac63-5d68a8332ecc	set_id
unii		2W4A77YPAN	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 width="60%"><col align="left" valign="top" width="45%"/><col align="left" valign="top" width="55%"/><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Burning</td><td styleCode="Rrule">Perioral dermatitis</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Itching</td><td styleCode="Rrule">Allergic contact dermatitis</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Irritation</td><td styleCode="Rrule">Maceration of the skin</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Dryness</td><td styleCode="Rrule">Secondary infection</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Folliculitis</td><td styleCode="Rrule">Skin atrophy</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Hypertrichosis</td><td styleCode="Rrule">Striae</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Acneiform eruptions</td><td styleCode="Rrule">Miliaria</td></tr><tr><td styleCode="Lrule Rrule">Hypopigmentation</td><td styleCode="Rrule"/></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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