Home NDC 35324-003 DermaZinc
Product NDC 35324-003
11-digit product format 353240003
Labeler code 35324
Product ID 35324-003_35fc83a7-c563-853f-e063-6294a90a4682
Type HUMAN OTC DRUG
Nonproprietary name pyrithione zinc
Dosage form SHAMPOO
Route TOPICAL
Labeler WynnPharm Inc
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-08-29
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 DermaZinc
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 244458 Internal RxNorm lookup 1721127 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 35324-003-08 DermaZinc 240 mL in 1 BOTTLE, DISPENSING SHAMPOO 240 4 35324-003-16 DermaZinc 473 mL in 1 BOTTLE, DISPENSING SHAMPOO 473 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35324-003 DERMAZINC (PYRITHIONE ZINC) SHAMPOO [WYNNPHARM INC] 4 Current NDC, Legacy NDC, 2 package rows 20250527_e71e87ba-2a62-44f3-e053-2995a90a8b11.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 Marketing end Sample Exclude flag Status 35324-003-08 35324000308 240 mL in 1 BOTTLE, DISPENSING (35324-003-08) 240 ml 2022-08-29 0000-00-00 No No Current 35324-003-16 35324000316 473 mL in 1 BOTTLE, DISPENSING (35324-003-16) 473 ml 2025-05-25 No No Current