1% ketoconazole

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: 1% ketoconazole
Generic name: KETOCONAZOLE
Manufacturer: TAGRID LLC
Product type: HUMAN OTC DRUG
SPL set ID: 30b75584-3a1e-c125-e063-6294a90acaa7
SPL ID: 1b9d0aa4-ace1-48b8-a76f-ddf34c238320
Version: 2
Effective date: 2025-03-19
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 02:56:08

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M005	openfda.application_number
brand name		1% ketoconazole	openfda.brand_name
generic name		KETOCONAZOLE	openfda.generic_name
manufacturer name		TAGRID LLC	openfda.manufacturer_name
ndc	package	85384-0001-1	openfda.package_ndc
ndc	product	85384-0001	openfda.product_ndc
ndc11	package	85384000101	derived:openfda.package_ndc
rxcui		240812	openfda.rxcui
spl id		1b9d0aa4-ace1-48b8-a76f-ddf34c238320	id
spl set id		30b75584-3a1e-c125-e063-6294a90acaa7	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 the scalp that is broken or inflamed if you are allergic to ingredients in this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. If the rash appears or the condition worsens does not improve in 2-4 weeks. ask a doctor before use If swallowed, get medical help or contact a Posion Control Center immediately

Reported adverse events (FAERS/openFDA)#

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