Home NDC 84167-192 APUREE Prorevive Maximum Strength Antifungal
Product NDC 84167-192
11-digit product format 841670192
Labeler code 84167
Product ID 84167-192_58860bba-91eb-c63f-e063-6394a90ac91c
Type HUMAN OTC DRUG
Nonproprietary name COLLOIDAL SULFUR
Dosage form CREAM
Route TOPICAL
Labeler Guangzhou Meixi Biotechnology Co., Ltd.
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-08
Substance UNDECYLENIC ACID; ZINC UNDECYLENATE
Active strength 15; 10 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 Prorevive Maximum Strength Antifungal
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UNDECYLENIC ACID 15 g/1 ZINC UNDECYLENATE 10 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K3D86KJ24N Internal UNII lookup 388VZ25DUR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2749266 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 37 of 55 · 1,088 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84167-192-11 84167019211 1 BAG in 1 BOX (84167-192-11) / 1 CREAM in 1 BAG 1 bag 2026-08-08 No No Current