Home NDC 57337-024 XtraCare Anti-Dandruff Hair Cleanse
Product NDC 57337-024
11-digit product format 573370024
Labeler code 57337
Product ID 57337-024_126c756d-69d4-085d-e063-6294a90ae640
Type HUMAN OTC DRUG
Nonproprietary name PYRITHIONE ZINC
Dosage form SHAMPOO
Route TOPICAL
Labeler Rejoice International Inc.
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-10-09
Substance PYRITHIONE ZINC
Active strength 20 mg/400mg
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 XtraCare Anti-Dandruff Hair Cleanse
Brand name suffix Coconut and Shea Butter
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PYRITHIONE ZINC 20 mg/400mg
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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57337-024-01 XtraCare Anti-Dandruff Hair CleanseCoconut and Shea Butter 400 mg in 1 BOTTLE SHAMPOO 400 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-024 XTRACARE ANTI-DANDRUFF HAIR CLEANSE COCONUT AND SHEA BUTTER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240229_7d9bf611-db24-4915-9b13-b7b36f47711f.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 31 of 31 · 615 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57337-024-01 57337002401 400 mg in 1 BOTTLE (57337-024-01) 400 mg 2013-10-09 0000-00-00 No No Current