Home NDC 80569-084 FLUSH Maximum Strength Antifungal formula
Product NDC 80569-084
11-digit product format 805690084
Labeler code 80569
Product ID 80569-084_09e240de-0009-c20f-e063-6294a90a09c4
Type HUMAN OTC DRUG
Nonproprietary name UNDECYLENIC ACID
Dosage form LIQUID
Route TOPICAL
Labeler Triple Point Group, LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-09-17
Substance UNDECYLENIC ACID
Active strength 250 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base FLUSH Maximum Strength Antifungal formula
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UNDECYLENIC ACID 250 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K3D86KJ24N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998329 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80569-084-15 FLUSH Maximum Strength Antifungal formula 15 mL in 1 BOTTLE, GLASS LIQUID 15 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80569-084 FLUSH MAXIMUM STRENGTH ANTIFUNGAL FORMULA (UNDECYLENIC ACID) LIQUID [TRIPLE POINT GROUP, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20231112_1d9e56ef-c7c9-4aff-ab9e-b163e566e3d5.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 8 of 49 · 973 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 80569-084-15 80569008415 15 mL in 1 BOTTLE, GLASS (80569-084-15) 15 ml 2020-09-17 0000-00-00 No No Current