Home NDC 84558-022 antifungal pen
Product NDC 84558-022
11-digit product format 845580022
Labeler code 84558
Product ID 84558-022_5755ef4e-46a3-624d-e063-6394a90a7868
Type HUMAN OTC DRUG
Nonproprietary name antifungal pen
Dosage form LIQUID
Route TOPICAL
Labeler GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-24
Substance TOLNAFTATE
Active strength 1 g/100U
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 antifungal pen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE 1 g/100U
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 06KB629TKV Internal UNII 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 8 of 49 · 973 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84558-022-01 84558002201 2 U in 1 BOX (84558-022-01) 2 u 2026-06-24 No No Current 84558-022-02 84558002202 3 U in 1 BOX (84558-022-02) 3 u 2026-06-24 No No Current 84558-022-03 84558002203 1 U in 1 BOX (84558-022-03) 1 u 2026-06-24 No No Current