FLUSH Maximum Strength Antifungal formula

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: FLUSH Maximum Strength Antifungal formula
Generic name: UNDECYLENIC ACID
Manufacturer: Triple Point Group, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 1d9e56ef-c7c9-4aff-ab9e-b163e566e3d5
SPL ID: 09e240de-0009-c20f-e063-6294a90a09c4
Version: 6
Effective date: 2023-11-11
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:03:34

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		FLUSH Maximum Strength Antifungal formula	openfda.brand_name
generic name		UNDECYLENIC ACID	openfda.generic_name
manufacturer name		Triple Point Group, LLC	openfda.manufacturer_name
ndc	package	80569-084-15	openfda.package_ndc
ndc	product	80569-084	openfda.product_ndc
ndc11	package	80569008415	derived:openfda.package_ndc
rxcui		998329	openfda.rxcui
spl id		09e240de-0009-c20f-e063-6294a90a09c4	id
spl set id		1d9e56ef-c7c9-4aff-ab9e-b163e566e3d5	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. Ask a doctor before use on children under two years of age DO NOT USE on diaper rash. When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs there is no improvement within four weeks. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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