Home NDC 11344-153 Dandruff
Product NDC 11344-153
11-digit product format 113440153
Labeler code 11344
Product ID 11344-153_4cd63c29-0bf3-9973-e063-6294a90af2fb
Type HUMAN OTC DRUG
Nonproprietary name Pyrithione Zinc
Dosage form SHAMPOO
Route TOPICAL
Labeler Nice-Pak Products, LLC
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-14
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 Dandruff
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11344-153-32 Dandruff 370 mL in 1 BOTTLE, PLASTIC SHAMPOO 370 2
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 11344-153-32 11344015332 370 mL in 1 BOTTLE, PLASTIC (11344-153-32) 370 ml 2025-08-14 No No Current