Home NDC 76162-970 Pyrithione zinc
Product NDC 76162-970
11-digit product format 761620970
Labeler code 76162
Product ID 76162-970_4ab95f11-c8a5-04b5-e063-6294a90a79d9
Type HUMAN OTC DRUG
Nonproprietary name Pyrithione zinc
Dosage form SHAMPOO
Route TOPICAL
Labeler Topco Associates LLC
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-25
Substance PYRITHIONE ZINC
Active strength 10 mg/mL
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 Pyrithione zinc
Listing expiration 2027-12-31
Active Ingredients# Ingredient, Strength table Ingredient Strength PYRITHIONE ZINC 10 mg/mL
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 209884 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 76162-970-32 Pyrithione zinc 370 mL in 1 BOTTLE, PLASTIC SHAMPOO 370 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76162-970 PYRITHIONE ZINC SHAMPOO [TOPCO ASSOCIATES LLC] 2 Current NDC, 1 package rows 20241027_2c1420a8-404f-4fd7-8f07-cd441b390ac2.zip
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 16 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 76162-970-32 76162097032 370 mL in 1 BOTTLE, PLASTIC (76162-970-32) 370 ml 2024-10-25 No No Current