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: Sun Pharmaceutical Industries, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 5782d791-48fd-4cee-853d-235eb4d04a40
SPL ID: 3972605f-b081-0289-e063-6294a90ab0e3
Version: 3
Effective date: 2025-07-08
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:54:00

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 · 18 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	071500	derived:openfda.application_number
application number		ANDA071500	openfda.application_number
brand name		Fluocinonide	openfda.brand_name
generic name		FLUOCINONIDE	openfda.generic_name
manufacturer name		Sun Pharmaceutical Industries, Inc.	openfda.manufacturer_name
ndc	package	51672-1386-1	openfda.package_ndc
ndc	package	51672-1386-4	openfda.package_ndc
ndc	package	51672-1386-2	openfda.package_ndc
ndc	package	51672-1386-3	openfda.package_ndc
ndc	product	51672-1386	openfda.product_ndc
ndc11	package	51672138603	derived:openfda.package_ndc
ndc11	package	51672138602	derived:openfda.package_ndc
ndc11	package	51672138604	derived:openfda.package_ndc
ndc11	package	51672138601	derived:openfda.package_ndc
rxcui		103456	openfda.rxcui
spl id		3972605f-b081-0289-e063-6294a90ab0e3	id
spl set id		5782d791-48fd-4cee-853d-235eb4d04a40	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 Hypertrichosis Maceration of the Skin Itching Acneiform Eruptions Secondary Infection Irritation Hypopigmentation Skin Atrophy Dryness Perioral Dermatitis Striae Folliculitis Allergic Contact Dermatitis Miliaria

adverse reactions table

<table width="80%" styleCode="Noautorules"><col width="26%" align="left" valign="top"/><col width="37%" align="left" valign="top"/><col width="37%" align="left" valign="top"/><tbody><tr><td>Burning</td><td>Hypertrichosis</td><td>Maceration of the Skin</td></tr><tr><td>Itching</td><td>Acneiform Eruptions</td><td>Secondary Infection</td></tr><tr><td>Irritation</td><td>Hypopigmentation</td><td>Skin Atrophy</td></tr><tr><td>Dryness</td><td>Perioral Dermatitis</td><td>Striae</td></tr><tr><td>Folliculitis</td><td>Allergic Contact Dermatitis</td><td>Miliaria</td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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