Home NDC 57337-057 XtraCare Foaming Hand Sanitizer
Product NDC 57337-057
11-digit product format 573370057
Labeler code 57337
Product ID 57337-057_126d7580-4eff-8635-e063-6294a90a77c0
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form GEL
Route TOPICAL
Labeler Rejoice International
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-02-18
Substance BENZALKONIUM CHLORIDE
Active strength 3 g/207g
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 Foaming Hand Sanitizer
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 3 g/207g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1098199 Internal RxNorm 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 57337-057-01 XtraCare Foaming Hand Sanitizer 207 g in 1 PACKAGE GEL 207 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-057 XTRACARE FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [REJOICE INTERNATIONAL] 3 Current NDC, Legacy NDC, 1 package rows 20240229_3082cbbb-a0ed-45eb-a116-ad1c65357dd1.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 110 of 115 · 2,286 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 57337-057-01 57337005701 207 g in 1 PACKAGE (57337-057-01) 207 g 2014-02-18 0000-00-00 No No Current