Home NDC 84167-423-01 APUREE Nailtific Extra-Max Strength Daytime Antigungal
Product NDC 84167-423
Requested package NDC 84167-423-01
11-digit product format 841670423
Labeler code 84167
Product ID 84167-423_4e3d226b-57f2-75a6-e063-6394a90a96cd
Type HUMAN OTC DRUG
Nonproprietary name APUREE Nailtific Extra-Max Strength Daytime Antigungal
Dosage form LIQUID
Route TOPICAL
Labeler Guangzhou Meixi Biotechnology Co., Ltd.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-30
Substance TOLNAFTATE; UNDECYLENIC ACID
Active strength 1; 25 g/1; g/1
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 APUREE Nailtific Extra-Max Strength Daytime Antigungal
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE 1 g/1 UNDECYLENIC ACID 25 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 06KB629TKV 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 2691548 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84167-423-01 APUREE Nailtific Extra-Max Strength Daytime Antigungal 1 in 1 BOX LIQUID 1 1 84167-423-01 APUREE Nailtific Extra-Max Strength Daytime Antigungal 30 in 1 VIAL, SINGLE-USE LIQUID 30 1
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 47 of 49 · 969 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 84167-423-01 84167042301 1 VIAL, SINGLE-USE in 1 BOX (84167-423-01) / 30 LIQUID in 1 VIAL, SINGLE-USE 2026-03-30 No No Current