Tolfyra

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: Tolfyra
Generic name: TOLNAFTATE
Manufacturer: Oncora Pharma, LLC
Product type: HUMAN OTC DRUG
SPL set ID: b28ee9f2-fc45-4336-b374-be7aa51d44e9
SPL ID: 9a2daff0-df69-4dd4-9b2b-84d1b74de374
Version: 6
Effective date: 2026-05-11
Source export date: 2026-11-06
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/4dafeb36642dffb72e2138939a956de402f722ea8c14c08cd87068efd3669f01/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:48:30

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		Tolfyra	openfda.brand_name
generic name		TOLNAFTATE	openfda.generic_name
manufacturer name		Oncora Pharma, LLC	openfda.manufacturer_name
ndc	package	85477-331-01	openfda.package_ndc
ndc	product	85477-331	openfda.product_ndc
ndc11	package	85477033101	derived:openfda.package_ndc
rxcui		313423	openfda.rxcui
spl id		9a2daff0-df69-4dd4-9b2b-84d1b74de374	id
spl set id		b28ee9f2-fc45-4336-b374-be7aa51d44e9	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 unless directed by a doctor. When using this product ■ do not get into eyes Stop use and ask a doctor ■ for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks ■ for prevention of athlete’s foot - if irritation occurs, discontinue use and consult a doctor Keep out of reach of children. 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.