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: Padagis Israel Pharmaceuticals Ltd
Product type: HUMAN OTC DRUG
SPL set ID: 3dcd0158-ec51-4fa7-a26a-02c2926156c0
SPL ID: 467f8f2f-09b1-4701-b796-57a10576f7ca
Version: 8
Effective date: 2026-01-22
Source export date: 2026-11-06
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/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:53:11

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 · 13 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		Padagis Israel Pharmaceuticals Ltd	openfda.manufacturer_name
ndc	package	45802-434-01	openfda.package_ndc
ndc	package	45802-434-11	openfda.package_ndc
ndc	product	45802-434	openfda.product_ndc
ndc11	package	45802043401	derived:openfda.package_ndc
ndc11	package	45802043411	derived:openfda.package_ndc
rxcui		309367	openfda.rxcui
spl id		467f8f2f-09b1-4701-b796-57a10576f7ca	id
spl set id		3dcd0158-ec51-4fa7-a26a-02c2926156c0	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 Do not use on children under 2 years of age unless directed by a doctor When using this product avoid contact with the 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. (1-800-222-1222)

Reported adverse events (FAERS/openFDA)#

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