Thera plus Antifungal Tolnaftate

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: Thera plus Antifungal Tolnaftate
Generic name: TOLNAFTATE
Manufacturer: FOURSTAR GROUP USA, INC.
Product type: HUMAN OTC DRUG
SPL set ID: c628dda8-7a6d-5f3a-e053-2995a90a35f8
SPL ID: 08a0d819-d9c5-15e9-e063-6294a90acb44
Version: 2
Effective date: 2023-10-26
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 05:52:53

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		Thera plus Antifungal Tolnaftate	openfda.brand_name
generic name		TOLNAFTATE	openfda.generic_name
manufacturer name		FOURSTAR GROUP USA, INC.	openfda.manufacturer_name
ndc	package	80684-040-01	openfda.package_ndc
ndc	product	80684-040	openfda.product_ndc
ndc11	package	80684004001	derived:openfda.package_ndc
rxcui		103951	openfda.rxcui
spl id		08a0d819-d9c5-15e9-e063-6294a90acb44	id
spl set id		c628dda8-7a6d-5f3a-e053-2995a90a35f8	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. Do not use on children under 2 years of age except under the advice and supervision of 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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