Home NDC 57337-021-01 XtraCare Antibacterial Hand Cleanse
Product NDC 57337-021
Requested package NDC 57337-021-01
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 110 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sunmark Hydrogen Peroxide 3 Percent HYDROGEN PEROXIDE Strategic Sourcing Services LLC c79ae066-8b3b-400d-8b26-f41100e7f534 2023-12-19 Warnings Exact identifier application number: M003 Sunmark Iodides Tincture ETHYL ALCOHOL Strategic Sourcing Services LLC 5e227f79-fca7-4633-97ea-61da4060fe92 2023-12-19 Warnings Exact identifier application number: M003 sunmark Povidone-Iodine Topical POVIDONE-IODINE Strategic Sourcing Services LLC acc349d6-2875-4814-aa6e-828fffec7f07 2023-12-19 Warnings Exact identifier application number: M003 DDM Iodine Tincture Mild IODINE AND SODIUM IODIDE AND ALCOHOL Discount Drug Mart 5d538c8e-bf87-d85c-e053-2991aa0af729 2023-12-19 Warnings Exact identifier application number: M003 DDM Decolorized Iodine ETHYL ALCOHOL Discount Drug Mart 5d570ea7-ab08-54b7-e053-2991aa0a7a83 2023-12-19 Warnings Exact identifier application number: M003 DDM Povidone Iodine POVIDONE IODINE 10% Discount Drug Mart 5d161a9d-0462-0afd-e053-2991aa0a22e2 2023-12-19 Warnings Exact identifier application number: M003 HEB Povidone Iodine POVIDONE IODINE 10% H E B 5d576ce2-7d63-c860-e053-2a91aa0a072c 2023-12-18 Warnings Exact identifier application number: M003 Publix Povidone Iodine POVIDONE IODINE 10% Publix 5d6bba46-2571-4957-e053-2a91aa0a2e85 2023-12-18 Warnings Exact identifier application number: M003 Top Care Decolorized Iodine ETHYL ALCOHOL TOPCO ASSOCIATES LLC 5d6bdc17-5c3a-7dec-e053-2991aa0aa450 2023-12-18 Warnings Exact identifier application number: M003 Tincture Merthiolate BENZALKONIUM CHLORIDE DLC Laboratories, Inc 4fec9119-fbbf-4fc7-9122-c6300cac8731 2023-12-18 Warnings Exact identifier application number: M003 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL New Pride Corp 0c9e1e9c-b8fc-1932-e063-6394a90a09bf 2023-12-16 Warnings Exact identifier application number: M003 DermaWound Wound Care POVIDONE-IODINE Progressive Doctors, LLC 2d49daa7-aa02-4219-880b-e1697bde8a7e 2023-12-15 Warnings Exact identifier application number: M003 Ethyl Rubbing Alcohol ALCOHOL Humco Holding Group, Inc. 829f3e16-7a9b-4da7-87d2-f58254bda721 2023-12-15 Warnings Exact identifier application number: M003 Humco Iodides Tincture ETHYL ALCOHOL Humco Holding Group, Inc. d230e3a2-1cde-44a9-82c3-3dc5474b3a72 2023-12-15 Warnings Exact identifier application number: M003 Humco Hydrogen Peroxide HYDROGEN PEROXIDE 3% Humco Holding Group, Inc. 2fdd3aa0-e45e-46bb-aa01-88e59d8afbfd 2023-12-15 Warnings Exact identifier application number: M003 HUMCO Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL Humco Holding Group, Inc. c220b916-6914-435f-84e2-ba828c9916b1 2023-12-15 Warnings Exact identifier application number: M003 HUMCO Isopropyl Rubbing Alcohol 70% Professional Pack ISOPROPYL ALCOHOL Humco Holding Group, Inc. 8de61fdd-8bb9-4845-9129-97bed0686a68 2023-12-15 Warnings Exact identifier application number: M003 HUMCO Merthiolate BENZALKONIUM CHLORIDE Humco Holding Group, Inc. 864063a5-c6cc-4657-9cd6-51af4673bf98 2023-12-15 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE SPRAY 5% Humco Holding Group, Inc. a7bb80c4-bbc0-21ea-e053-2995a90a52c1 2023-12-15 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE IODINE 10% Humco Holding Group, Inc. 6064c23b-7c15-208d-e053-2991aa0a00f6 2023-12-15 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