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: FAMILY WELLNESS TOLNAFTATE
Manufacturer: Trifecta Pharmaceuticals USA, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 915759af-0d7f-6a87-e053-2a95a90acbd6
SPL ID: 29b3b3a6-1e40-3efa-e063-6294a90a15c2
Version: 5
Effective date: 2024-12-20
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:53:46

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		Tolnaftate Cream 1% ANTIFUNGAL	openfda.brand_name
generic name		FAMILY WELLNESS TOLNAFTATE	openfda.generic_name
manufacturer name		Trifecta Pharmaceuticals USA, LLC	openfda.manufacturer_name
ndc	package	69396-042-05	openfda.package_ndc
ndc	product	69396-042	openfda.product_ndc
ndc11	package	69396004205	derived:openfda.package_ndc
rxcui		103951	openfda.rxcui
spl id		29b3b3a6-1e40-3efa-e063-6294a90a15c2	id
spl set id		915759af-0d7f-6a87-e053-2a95a90acbd6	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 doctor.

Reported adverse events (FAERS/openFDA)#

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