Home NDC 84558-012 anti-fungal
Product NDC 84558-012
11-digit product format 845580012
Labeler code 84558
Product ID 84558-012_3b108a73-681a-a6c3-e063-6394a90a0bca
Type HUMAN OTC DRUG
Nonproprietary name anti-fungal shampoo
Dosage form SHAMPOO
Route TOPICAL
Labeler GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-30
Substance PIROCTONE OLAMINE; SALICYLIC ACID
Active strength .08; 2 g/100mL; g/100mL
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 anti-fungal
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIROCTONE OLAMINE .08 g/100mL SALICYLIC ACID 2 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination A4V5C6R9FB Internal UNII lookup O414PZ4LPZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2720077 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 84558-012-01 anti-fungal 300 mL in 1 BOTTLE SHAMPOO 300 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 31 of 31 · 615 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84558-012-01 84558001201 300 mL in 1 BOTTLE (84558-012-01) 300 ml 2025-07-30 No No Current