Home NDC 57337-023 XtraCare Antibacterial Hand Cleanse
Product NDC 57337-023
11-digit product format 573370023
Labeler code 57337
Product ID 57337-023_126c40d2-9d18-e72a-e063-6294a90ad790
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 2013-08-30
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 Strawberry Pomegranate
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 57337-023-01 XtraCare Antibacterial Hand CleanseStrawberry Pomegranate 221 mL in 1 BOTTLE SOAP 221 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRICLOSAN ACTIVE INGREDIENT 4NM5039Y5X XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 4 TRICLOSAN ACTIVE MOIETY 4NM5039Y5X XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 4 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 4 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 4 COCO DIETHANOLAMIDE INACTIVE INGREDIENT 92005F972D XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 4 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 4 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 4 METHYLCHLOROISOTHIAZOLINONE INACTIVE INGREDIENT DEL7T5QRPN XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 4 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 4 PEG-150 DISTEARATE INACTIVE INGREDIENT 6F36Q0I0AC XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 4 SODIUM C14-16 OLEFIN SULFONATE INACTIVE INGREDIENT O9W3D3YF5U XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 4 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 4 SODIUM LAURETH SULFATE INACTIVE INGREDIENT BPV390UAP0 XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-023 XTRACARE ANTIBACTERIAL HAND CLEANSE STRAWBERRY POMEGRANATE (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20240229_b68a7d64-2650-4fc6-a89e-05de9098a2a3.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 92 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join germstarCitrus ETHYL ALCOHOL Soaptronic, LLC 779abef7-53ff-47c3-b7e6-27570eb055b3 2024-12-19 Warnings Exact identifier application number: M003 germstarGel ETHYL ALCOHOL Soaptronic, LLC b5fd6c3c-d452-74e6-e053-2995a90a9090 2024-12-19 Warnings Exact identifier application number: M003 Isopropyl alcohol 91 percent ISOPROPYL ALCOHOL Jell Pharmaceuticals Pvt. Ltd. cd98812b-017a-2cd2-e053-2a95a90a38ce 2024-12-18 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 50% ISOPROPYL ALCOHOL MY IMPORTS LLC d4d72406-067d-1f67-e053-2995a90a1a9f 2024-12-18 Warnings Exact identifier application number: M003 AMORAY 70% ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL MY IMPORT USA INC 7114b527-106b-4629-867c-63dba13635a2 2024-12-18 Warnings Exact identifier application number: M003 AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d7e7f8-7c8a-2b51-e053-2995a90a63d0 2024-12-18 Warnings Exact identifier application number: M003 ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN ISOPROPYL ALCOHOL My Imports USA, LLC d4d77ec3-4930-74f0-e053-2a95a90a962a 2024-12-18 Warnings Exact identifier application number: M003 91% Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d7adaf-c0fd-82fa-e053-2995a90ab9f6 2024-12-18 Warnings Exact identifier application number: M003 ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN ISOPROPYL ALCOHOL MY IMPORTS USA, LLC de47bf08-f64e-781d-e053-2a95a90ab08f 2024-12-18 Warnings Exact identifier application number: M003 AMERICAN REDCROSS 91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d80ae4-3fba-4605-e053-2a95a90a2119 2024-12-18 Warnings Exact identifier application number: M003 American Red Cross 50% Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL MY IMPORTS USA LLC de47a879-9cd0-5fbb-e053-2a95a90a1fba 2024-12-18 Warnings Exact identifier application number: M003 RUBBING ALCOHOL ALCOHOL INTERNATIONAL GENERAL TRADING CORP bd5ee961-1d64-0d9d-e053-2a95a90a6010 2024-12-18 Warnings Exact identifier application number: M003 70% Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL SZY Holdings, LLC dba EverReady First Aid 1e39b0f4-66d1-47ac-aed6-d6ac019888ce 2024-12-18 Warnings Exact identifier application number: M003 RUBBING ALCOHOL ALCOHOL INTERNATIONAL GENERAL TRADING CORP bd5eb0df-cd2d-691c-e053-2995a90a2511 2024-12-18 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL First Aid Research Corp. 7d1c0382-31b3-48d0-a514-c5cc45a2299e 2024-12-18 Warnings Exact identifier application number: M003 First Aid Only First Aid-Burn BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE Acme United Corporation f31a44ff-e4ac-de1e-e053-2a95a90ab036 2024-12-18 Warnings Exact identifier application number: M003 Hand Sanitizer (Lavender Rosemary) HAND SANITIZER SPRAY Tubby Todd 2992a52a-21a9-18be-e063-6294a90a834d 2024-12-18 Warnings Exact identifier application number: M003 CVS Decolorized Iodine ALCOHOL CVS Pharmacy d9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd 2024-12-18 Warnings Exact identifier application number: M003 De La Cruz Decolorized Iodine ETHYL ALCOHOL DLC Laboratories, Inc. 5d8f6aaa-0b87-1166-e053-2991aa0a297f 2024-12-18 Warnings Exact identifier application number: M003 Humco Povidone Iodine POVIDONE IODINE 10% Humco Holding Group, Inc. 1e078022-f32c-48bd-8add-f83aebcc5812 2024-12-18 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 57337-023-01 57337002301 221 mL in 1 BOTTLE (57337-023-01) 221 ml 2013-08-30 0000-00-00 No No Current