CLOTRIMAZOLE

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: CLOTRIMAZOLE
Generic name: CLOTRIMAZOLE
Manufacturer: Rugby Laboratories, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 2c60e631-5930-4420-886d-eb1990c720b6
SPL ID: 51921fa3-cebb-5959-e063-6294a90aaca2
Version: 4
Effective date: 2026-05-11
Source export date: 2026-10-27
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/55ffdfed5c29f1b4aed512886bd3fb7831e157cc4948137779971a558752ed2b/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:06:55

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		CLOTRIMAZOLE	openfda.brand_name
generic name		CLOTRIMAZOLE	openfda.generic_name
manufacturer name		Rugby Laboratories, Inc.	openfda.manufacturer_name
ndc	package	0536-1443-70	openfda.package_ndc
ndc	product	0536-1443	openfda.product_ndc
ndc11	package	00536144370	derived:openfda.package_ndc
rxcui		309370	openfda.rxcui
spl id		51921fa3-cebb-5959-e063-6294a90aaca2	id
spl set id		2c60e631-5930-4420-886d-eb1990c720b6	set_id
unii		G07GZ97H65	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

Warnings For external use only Ask a doctor before use on children under 2 years of age. When using this product avoid contact with eyes Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch) Keep out of reach of children. 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.