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: Encube Ethicals, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: cb869315-8011-485b-8992-1d73fb27e19e
SPL ID: d17e15ec-9150-4fe3-acd1-4573300d9bf3
Version: 2
Effective date: 2025-09-09
Source export date: 2026-09-28
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/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:19:50

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	211410	derived:openfda.application_number
application number		ANDA211410	openfda.application_number
brand name		FLUOCINONIDE	openfda.brand_name
generic name		FLUOCINONIDE	openfda.generic_name
manufacturer name		Encube Ethicals, Inc.	openfda.manufacturer_name
ndc	package	21922-064-05	openfda.package_ndc
ndc	package	21922-064-04	openfda.package_ndc
ndc	package	21922-064-03	openfda.package_ndc
ndc	package	21922-064-07	openfda.package_ndc
ndc	product	21922-064	openfda.product_ndc
ndc11	package	21922006404	derived:openfda.package_ndc
ndc11	package	21922006407	derived:openfda.package_ndc
ndc11	package	21922006405	derived:openfda.package_ndc
ndc11	package	21922006403	derived:openfda.package_ndc
rxcui		103456	openfda.rxcui
spl id		d17e15ec-9150-4fe3-acd1-4573300d9bf3	id
spl set id		cb869315-8011-485b-8992-1d73fb27e19e	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 Itching Irritation Dryness Folliculitis Hypertrichosis Acneiform Eruptions Hypopigmentation Perioral Dermatitis Allergic Contact Dermatitis Maceration of the Skin Secondary Infection Skin Atrophy Striae Miliaria To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

adverse reactions table

<table styleCode="Noautorules" width="100%"><col width="34%" align="left" valign="middle"/><col width="33%" align="left" valign="middle"/><col width="33%" align="left" valign="middle"/><tbody><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph>Burning Itching Irritation Dryness Folliculitis</paragraph></td><td styleCode="Botrule Rrule Toprule"><paragraph>Hypertrichosis Acneiform Eruptions Hypopigmentation Perioral Dermatitis Allergic Contact Dermatitis</paragraph></td><td styleCode="Botrule Rrule Toprule"><paragraph>Maceration of the Skin</paragraph><paragraph>Secondary Infection</paragraph><paragraph>Skin Atrophy</paragraph><paragraph>Striae</paragraph><paragraph>Miliaria</paragraph></td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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