Tagrit Antifungal Treament Ketoconazole 1%

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: Tagrit Antifungal Treament Ketoconazole 1%
Generic name: KETOCONAZOLE
Manufacturer: TAGRID LLC
Product type: HUMAN OTC DRUG
SPL set ID: 315a8832-c42f-c07a-e063-6394a90a8218
SPL ID: a42bf040-8183-4a90-bf21-4596f5eacfc5
Version: 2
Effective date: 2025-03-27
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:55:45

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 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M005	openfda.application_number
brand name		Tagrit Antifungal Treament Ketoconazole 1%	openfda.brand_name
generic name		KETOCONAZOLE	openfda.generic_name
manufacturer name		TAGRID LLC	openfda.manufacturer_name
ndc	package	85384-0002-1	openfda.package_ndc
ndc	product	85384-0002	openfda.product_ndc
ndc11	package	85384000201	derived:openfda.package_ndc
spl id		a42bf040-8183-4a90-bf21-4596f5eacfc5	id
spl set id		315a8832-c42f-c07a-e063-6394a90a8218	set_id
unii		R9400W927I	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

For external use only. on broken, inflamed, or severely irritated skin. lf you are allergic to Ketoconazole or any other ingredients in this product. Avoid contact with the eyes. If the product gets into the eyes, rinse thoroughly with water. Stop use and ask a doctor if: a rash appears. the condition does not improve within 2-4 weeks of regular use. ask a healthcare provider before use. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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