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 99 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hand Sanitizer Lavender ETHYL ALCOHOL Whole Foods Market, Inc. 0742f251-5fc9-c015-e063-6394a90a79b1 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Orange Blossom ETHYL ALCOHOL Whole Foods Market, Inc. 07436407-7a15-7cee-e063-6294a90a9651 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Lavender ETHYL ALCOHOL Whole Foods Market, Inc. 07f7e966-e57e-dede-e063-6294a90acbf5 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Lavender ETHYL ALCOHOL Whole Foods Market, Inc. ec8c7597-a3f1-65a8-e053-2995a90a69a1 2024-11-02 Warnings Exact identifier application number: M003 Lemongrass Hand Sanitizer ALCOHOL Natural Essentials, Inc. 25ca3908-24aa-5e4f-e063-6394a90a7a88 2024-10-31 Warnings Exact identifier application number: M003 Sanar Naturals Decolorized Iodine ETHYL ALCOHOL Sanvall Enterprises, Inc 16c92427-84d2-cad5-e063-6394a90af435 2024-10-31 Warnings Exact identifier application number: M003 Sanar Naturals Mercurochrome BENZALKONIUM CHLOLRIDE Sanvall Enterprises, Inc 16c6c2f0-0f08-e640-e063-6394a90aa01d 2024-10-31 Warnings Exact identifier application number: M003 Sanar Naturals Gentian Violet GENTIAN VIOLET Sanvall Enterprises, Inc 1922518d-e49b-5010-e063-6394a90a9112 2024-10-31 Warnings Exact identifier application number: M003 Lavender Hand Sanitizer ALCOHOL Natural Essentials, Inc. 25cada8c-8c80-c140-e063-6294a90a3336 2024-10-31 Warnings Exact identifier application number: M003 Peppermint Hand Sanitizer ALCOHOL Natural Essentials, Inc. 25cb382a-6e66-05e6-e063-6294a90a9165 2024-10-31 Warnings Exact identifier application number: M003 RITE AID Maximum strength pain relieving BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE RITE AID c87671cb-d736-4ec6-ab10-94dff54925b2 2024-10-30 Warnings Exact identifier application number: M003 H2OCEAN NOTHING BENZALKONIUM CL, LIDOCAINE HCL H2Ocean, LLC 77896ac3-960c-41ac-8b40-053f24526fe3 2024-10-23 Warnings Exact identifier application number: M003 Blue Green Foam BENZALKONIUM CHLORIDE H2Ocean, LLC 8627bf8b-2cce-45de-b37f-8478462645fa 2024-10-23 Warnings Exact identifier application number: M003 CVS HEALTH CONTINUOUS HAND SANITIZER ALCOHOL CVS PHARMACY c89a28ac-ab53-46dd-e053-2a95a90a3284 2024-10-22 Warnings Exact identifier application number: M003 TRADER JOES HAND SANITIZER LAVENDER ETHYL ALCOHOL Trader Joe's Company 4d782831-dab8-4553-9786-b5172813553e 2024-10-22 Warnings Exact identifier application number: M003 TRADER JOES HAND SANITIZER GRAPEFRUIT LEMON ALCOHOL Trader Joe's Company f4c1e80a-847b-4407-92b7-570c032bea60 2024-10-22 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 99% ISOPROPYL ALCOHOL Universal Distribution Center LLC 678a9b14-2838-4358-9673-fc23e0f58efb 2024-10-21 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL Universal Distribution Center LLC a9960d2f-f13a-4168-b2e9-d6f4a35d84ae 2024-10-21 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 50% ISOPROPYL ALCOHOL Universal Distribution Center LLC 5db1659e-3a13-47f0-90ae-f8f192c6111a 2024-10-21 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70% with Wintergreen ISOPROPYL ALCOHOL Universal Distribution Center LLC 3dcdc1cc-ece8-4b47-a236-ee57c375bb99 2024-10-21 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