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: Zydus Pharmaceuticals USA Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 73315c87-4e55-41ea-883b-23d504c1b10d
SPL ID: bd0eaa0d-0a5b-48a2-bc7e-78b8bde33962
Version: 5
Effective date: 2022-10-04
Source export date: 2026-09-28
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:35:48

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	208948	derived:openfda.application_number
application number		ANDA208948	openfda.application_number
brand name		Fluocinonide	openfda.brand_name
generic name		FLUOCINONIDE	openfda.generic_name
manufacturer name		Zydus Pharmaceuticals USA Inc.	openfda.manufacturer_name
ndc	package	70710-1284-3	openfda.package_ndc
ndc	package	70710-1284-8	openfda.package_ndc
ndc	product	70710-1284	openfda.product_ndc
ndc11	package	70710128408	derived:openfda.package_ndc
ndc11	package	70710128403	derived:openfda.package_ndc
rxcui		310364	openfda.rxcui
spl id		bd0eaa0d-0a5b-48a2-bc7e-78b8bde33962	id
spl set id		73315c87-4e55-41ea-883b-23d504c1b10d	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 ID="ID31" width="100%"><col width="33%"/><col width="34%"/><col width="33%"/><tbody><tr><td align="justify" valign="top">Burning </td><td align="justify" valign="top">Hypertrichosis </td><td align="justify" valign="top">Maceration of the skin </td></tr><tr><td align="justify" valign="top">Itching </td><td align="justify" valign="top">Acneiform eruptions </td><td align="justify" valign="top">Secondary infection </td></tr><tr><td align="justify" valign="top">Irritation </td><td align="justify" valign="top">Hypopigmentation </td><td align="justify" valign="top">Skin atrophy </td></tr><tr><td align="justify" valign="top">Dryness </td><td align="justify" valign="top">Perioral dermatitis </td><td align="justify" valign="top">Striae </td></tr><tr><td align="justify" valign="top">Folliculitis </td><td align="justify" valign="top">Allergic contact dermatitis </td><td align="justify" valign="top">Miliaria </td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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