Home FDA labels 46a43966-e83f-a3cc-e063-6394a90af22d 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 b0bc89a9-c9d5-4adb-9785-2d4487c4c656
SPL ID 46a43966-e83f-a3cc-e063-6394a90af22d
Version 8
Effective date 2025-12-23
Source export date 2026-08-01
Source partition 7
Source file https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-08-01/29baabee7fa6726d72190670d84f1571113181a958a8119cbe97e8f0d1d955b2/drug-label-0007-of-0014.json.zip
Source manifest SHA-256 bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run 20260801T225920Z
Imported at 2026-08-01 23:14:35 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 2 · 46 matching rows.
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 Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
adverse reactions table <table width="85%" styleCode="Noautorules"><col align="left" valign="top" width="20%"/><col align="left" valign="top" width="35%"/><col align="left" valign="top" width="45%"/><tbody><tr><td>Burning Itching Irritation Dryness Folliculitis </td><td>Hypertrichosis Acneiform Eruptions Hypopigmentation Perioral Dermatitis Allergic Contact Dermatitis </td><td>Maceration of the Skin Secondary Infection Skin Atrophy Striae Miliaria </td></tr></tbody></table>