TopCare Antifungal Maximum Strength

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: TopCare Antifungal Maximum Strength
Generic name: UNDECYLENIC ACID
Manufacturer: TOPCO ASSOCIATES LLC
Product type: HUMAN OTC DRUG
SPL set ID: 7c44fb4e-0eef-4ced-b03f-a02ebe6c0264
SPL ID: f35e1f5c-9f88-44d9-8496-b302551ed482
Version: 7
Effective date: 2025-12-22
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:54:46

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 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M005	openfda.application_number
brand name		TopCare Antifungal Maximum Strength	openfda.brand_name
generic name		UNDECYLENIC ACID	openfda.generic_name
manufacturer name		TOPCO ASSOCIATES LLC	openfda.manufacturer_name
ndc	package	36800-754-01	openfda.package_ndc
ndc	product	36800-754	openfda.product_ndc
ndc11	package	36800075401	derived:openfda.package_ndc
spl id		f35e1f5c-9f88-44d9-8496-b302551ed482	id
spl set id		7c44fb4e-0eef-4ced-b03f-a02ebe6c0264	set_id
unii		K3D86KJ24N	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 2 years of age unless directed by a doctor. When using this product • avoid contact with eyes Stop use and consult a doctor if • there is no improvement within 4 weeks • irritation occurs KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. If case of accidental ingestion, contact a physician, emergency medical care facility, or Poison Control Center immediately for advice at 1-800-222-1222.

Reported adverse events (FAERS/openFDA)#

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