Home NDC 84558-023 Kimtara Nail Fungus Treatment
Product NDC 84558-023
11-digit product format 845580023
Labeler code 84558
Product ID 84558-023_5678e533-8951-16e7-e063-6394a90a3633
Type HUMAN OTC DRUG
Nonproprietary name Kimtara Nail Fungus Treatment
Dosage form LIQUID
Route TOPICAL
Labeler GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-13
Substance TERBINAFINE; UNDECYLENIC ACID
Active strength 1; 25 g/100mL; g/100mL
Pharmacologic classes Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 Kimtara Nail Fungus Treatment
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERBINAFINE 1 g/100mL UNDECYLENIC ACID 25 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G7RIW8S0XP Internal UNII lookup 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 2747127 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 36 of 49 · 969 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84558-023-01 84558002301 3 mL in 1 BOX (84558-023-01) 3 ml 2026-07-13 No No Current 84558-023-02 84558002302 30 mL in 1 BOX (84558-023-02) 30 ml 2026-07-13 No No Current