Home NDC 57337-021 XtraCare Antibacterial Hand Cleanse
Product NDC 57337-021
11-digit product format 573370021
Labeler code 57337
Product ID 57337-021_126c392a-2f26-cd97-e063-6294a90a4f99
Type HUMAN OTC DRUG
Nonproprietary name Triclosan
Dosage form SOAP
Route TOPICAL
Labeler Rejoice International, Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-09-03
Substance TRICLOSAN
Active strength 3.3 mg/221mL
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 Antibacterial Hand Cleanse
Brand name suffix Original
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRICLOSAN 3.3 mg/221mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4NM5039Y5X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020118 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 57337-021-01 XtraCare Antibacterial Hand CleanseOriginal 221 mL in 1 BOTTLE SOAP 221 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRICLOSAN ACTIVE INGREDIENT 4NM5039Y5X XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3 TRICLOSAN ACTIVE MOIETY 4NM5039Y5X XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3 COCO DIETHANOLAMIDE INACTIVE INGREDIENT 92005F972D XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3 METHYLCHLOROISOTHIAZOLINONE INACTIVE INGREDIENT DEL7T5QRPN XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3 PEG-150 DISTEARATE INACTIVE INGREDIENT 6F36Q0I0AC XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3 SODIUM C14-16 OLEFIN SULFONATE INACTIVE INGREDIENT O9W3D3YF5U XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3 SODIUM LAURETH SULFATE INACTIVE INGREDIENT BPV390UAP0 XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-021 XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20240229_b5ce6663-fe82-4da1-923e-acea293d7a00.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 108 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join White Petrolatum WHITE PETROLATUM Nantong Health & Beyond Hygienic Products Inc. 0f0d6ff0-ff30-aaf8-e063-6394a90a2716 2024-01-16 Warnings Exact identifier application number: M003 Thompson Hand Sanitizer ETHYL ALCOHOL Thompson deada606-8a82-9eeb-e053-2a95a90a9e6d 2024-01-16 Warnings Exact identifier application number: M003 MyMedic Arnica Gel ARNICA MONTANA Nantong Health & Beyond Hygienic Products Inc. 0ef8760d-27c0-7ece-e063-6294a90a6873 2024-01-15 Warnings Exact identifier application number: M003 American Safety First Aid Antispetic HYDROGEN PEROXIDE Orazen Inc ea2fbdfe-1932-9fb4-e053-2a95a90a3563 2024-01-15 Warnings Exact identifier application number: M003 First Aid Antispetic BENZALKONIUM CHLORIDE Orazen Inc ea2debcb-892c-339f-e053-2a95a90a4b18 2024-01-15 Warnings Exact identifier application number: M003 Ever Ready First Aid BENZALKONIUM CHLORIDE, LIDOCAINE HCI Ever Ready First Aid e53f3bf5-25c0-2b86-e053-2a95a90a010f 2024-01-15 Warnings Exact identifier application number: M003 FIRST SHIELD First Aid Antiseptic BENZALKONIUM CHLORIDE Ever Ready First Aid e013ef0a-ef3d-7af5-e053-2a95a90a54d3 2024-01-15 Warnings Exact identifier application number: M003 Latalia Hand Sanitizer 80 Alcohol Antiseptic ALCOHOL INTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD ae55fab3-3177-383e-e053-2995a90a17a0 2024-01-10 Warnings Exact identifier application number: M003 Latalia Sanitizing Wipe ALCOHOL INTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD ae564635-898e-fbf6-e053-2995a90a8119 2024-01-10 Warnings Exact identifier application number: M003 Latalia Sanitizing Wipes ALCOHOL INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD af850b5e-c99f-3d4e-e053-2995a90a7948 2024-01-10 Warnings Exact identifier application number: M003 Latalia Alcohol Antiseptic 80 Sanitizing ALCOHOL INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD ba4b8fb3-09db-fa29-e053-2995a90a8617 2024-01-10 Warnings Exact identifier application number: M003 Northside Hospital Amenity Kit--GI Dept ALCOHOL ASP Global, LLc c284eba4-0b92-4981-b3f8-d8d99b58bdfd 2024-01-10 Warnings Exact identifier application number: M003 Meijer 3 Hydrogen Peroxide Wipes HYDROGEN PEROXIDE Meijer, Inc. 33143d87-3e57-4a17-a96c-b699ad034b5b 2024-01-09 Warnings Exact identifier application number: M003 Meijer 70 Isopropyl Alcohol Wipes First Aid Antiseptic ISOPROPYL ALCOHOL Meijer, Inc 2046162f-cb70-416c-ae37-14999883a807 2024-01-09 Warnings Exact identifier application number: M003 Lightning X Antiseptic BENZALKONIUM CHLORIDE Nantong Health & Beyond Hygienic Products Inc. 0e6b10e7-6e84-6bfc-e063-6294a90a8537 2024-01-08 Warnings Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE 3.0% Trifecta Pharmaceuticals USA, LLC. e4e45f11-7cd4-e693-e053-2a95a90a4c34 2024-01-02 Warnings Exact identifier application number: M003 GLOBAL CARE GOLD ANTIBACTERIAL HAND BENZALKONIUM CHLORIDE NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. 27ba0f30-e066-f240-e063-6394a90ae7cb 2024-01-01 Warnings Exact identifier application number: M003 Freskaro Decolorized Iodine ALCOHOL Pharma Nobis, LLC fbd222a2-1151-99b9-e053-6394a90a8bb8 2023-12-28 Warnings Exact identifier application number: M003 Alcohol Prep ISOPROPYL ALCOHOL Topco Associates 65270825-48b1-49e7-a14e-f73df9beb9dd 2023-12-27 Warnings Exact identifier application number: M003 Humco Hydrogen Peroxide HYDROGEN PEROXIDE 3% Pharma Nobis, LLC e42f876d-0477-c4d5-e053-2a95a90ae6d4 2023-12-26 Warnings Exact identifier application number: M003
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 57337-021-01 57337002101 221 mL in 1 BOTTLE (57337-021-01) 221 ml 2013-09-03 0000-00-00 No No Current