Tolnaftate Cream 1% ANTIFUNGAL

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: Tolnaftate Cream 1% ANTIFUNGAL
Generic name: TOLNAFTATE
Manufacturer: Trifecta Pharmaceuticals Usa Llc
Product type: HUMAN OTC DRUG
SPL set ID: 96a40ccd-17f7-4e4e-98da-207802fa2b2d
SPL ID: 352f8de3-8ff3-4098-e063-6294a90ace4d
Version: 8
Effective date: 2025-05-15
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 20:08:39

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 · 17 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M005	openfda.application_number
brand name		Tolnaftate Cream 1% ANTIFUNGAL	openfda.brand_name
generic name		TOLNAFTATE	openfda.generic_name
manufacturer name		Trifecta Pharmaceuticals Usa Llc	openfda.manufacturer_name
ndc	package	69396-016-66	openfda.package_ndc
ndc	package	69396-016-20	openfda.package_ndc
ndc	package	69396-016-05	openfda.package_ndc
ndc	package	69396-016-33	openfda.package_ndc
ndc	product	69396-016	openfda.product_ndc
ndc11	package	69396001666	derived:openfda.package_ndc
ndc11	package	69396001620	derived:openfda.package_ndc
ndc11	package	69396001605	derived:openfda.package_ndc
ndc11	package	69396001633	derived:openfda.package_ndc
rxcui		103951	openfda.rxcui
spl id		352f8de3-8ff3-4098-e063-6294a90ace4d	id
spl set id		96a40ccd-17f7-4e4e-98da-207802fa2b2d	set_id
unii		06KB629TKV	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. When using this product avoid contact with the eyes. Stop use and ask a healthcare professional if ● irritation occurs ● there is no improvement within 4 weeks improvement Do not use on children under 2 years of age except under the advice and supervision of a healthcare professional.

Reported adverse events (FAERS/openFDA)#

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