Home NDC 85521-002 DANDRX ANTI-DANDRUFF
Product NDC 85521-002
11-digit product format 855210002
Labeler code 85521
Product ID 85521-002_399fb50f-3b1f-3777-e063-6294a90a60ef
Type HUMAN OTC DRUG
Nonproprietary name Zinc Pyrithione
Dosage form SHAMPOO
Route TOPICAL
Labeler dandRX LLC
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-30
Substance PYRITHIONE ZINC
Active strength 2 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 DANDRX ANTI-DANDRUFF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PYRITHIONE ZINC 2 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R953O2RHZ5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 244458 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 85521-002-08 DANDRX ANTI-DANDRUFF 237 mL in 1 BOTTLE SHAMPOO 237 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 85521-002-08 85521000208 237 mL in 1 BOTTLE (85521-002-08) 237 ml 2025-07-30 No No Current