Fortinia Ultra

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: Fortinia Ultra
Generic name: CLOTRIMAZOLE 1%
Manufacturer: The Podiatree Company
Product type: HUMAN OTC DRUG
SPL set ID: 43065a59-fb81-b1c2-e063-6294a90a36e0
SPL ID: 43065a59-fb82-b1c2-e063-6294a90a36e0
Version: 2
Effective date: 2025-11-07
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 07:52:48

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		Fortinia Ultra	openfda.brand_name
generic name		CLOTRIMAZOLE 1%	openfda.generic_name
manufacturer name		The Podiatree Company	openfda.manufacturer_name
ndc	package	54633-025-15	openfda.package_ndc
ndc	product	54633-025	openfda.product_ndc
ndc11	package	54633002515	derived:openfda.package_ndc
rxcui		309370	openfda.rxcui
spl id		43065a59-fb82-b1c2-e063-6294a90a36e0	id
spl set id		43065a59-fb81-b1c2-e063-6294a90a36e0	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 • Do not use on children under 2 years of age unless directed by a doctor. • For external use only • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. • If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor. • 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.