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: Preferred Pharmaceuticals Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 70e1efac-1738-43db-b19c-bbe02810b6e7
SPL ID: 0b5c7bee-f91f-483b-98a4-0dfe7e9efa50
Version: 5
Effective date: 2026-04-01
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:43:45

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		333C	openfda.application_number
brand name		Clotrimazole	openfda.brand_name
generic name		CLOTRIMAZOLE	openfda.generic_name
manufacturer name		Preferred Pharmaceuticals Inc.	openfda.manufacturer_name
ndc	package	68788-8216-3	openfda.package_ndc
ndc	product	68788-8216	openfda.product_ndc
ndc11	package	68788821603	derived:openfda.package_ndc
rxcui		309367	openfda.rxcui
spl id		0b5c7bee-f91f-483b-98a4-0dfe7e9efa50	id
spl set id		70e1efac-1738-43db-b19c-bbe02810b6e7	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 within 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.