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 27 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diabetic First Aid Gel BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE Lavior Pharma Inc. bda875e6-06bd-930f-e053-2995a90ab197 2026-03-26 Warnings Exact identifier application number: M003 Povidone Iodine Prep Pad ANTISEPTIC Dynarex Corporation 81b475e8-8da4-7b15-e053-2991aa0a6629 2026-03-25 Warnings Exact identifier application number: M003 Antibacterial Hand Wipe ANTIBACTERIAL HAND WIPE Fujian Yifa Healthcare Products Co., Ltd. 4dde3373-1c75-a815-e063-6294a90aa557 2026-03-25 Warnings Exact identifier application number: M003 Los Poblanos Lavender Hand Sanitizer ALCOHOL Sombra Cosmetics Inc. 4ddef71b-f5b8-57f5-e063-6294a90a78a3 2026-03-25 Warnings Exact identifier application number: M003 palm party ALCOHOL HAND SANITIZER Dongyang Loulee Cosmetics Co.,Ltd. 48786094-aa70-d0ca-e063-6394a90acd88 2026-03-25 Warnings Exact identifier application number: M003 palm party ALCOHOL GEL Dongyang Loulee Cosmetics Co.,Ltd. 487c4724-b618-a071-e063-6394a90aa782 2026-03-25 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Bellini Glow ETHYL ALCOHOL MY IMPORTS USA LLC 4dbe636b-f376-7e30-e063-6394a90a722b 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Coconut Lime ETHYL ALCOHOL MY IMPORTS USA LLC 4dbe7020-e302-8706-e063-6394a90abe7c 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Island Vanilla ETHYL ALCOHOL MY IMPORTS USA LLC 4dbe79d2-ee73-a8ed-e063-6394a90a7db5 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pink Sugar ETHYL ALCOHOL MY IMPORTS USA LLC 4dbe8d3f-afac-cc82-e063-6294a90ae309 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Raspberry Lemonade ETHYL ALCOHOL MY IMPORTS USA LLC 4dcfcd41-b93f-accf-e063-6394a90a963d 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon Cream ETHYL ALCOHOL MY IMPORTS USA LLC 4dd00a64-c0bf-cf7d-e063-6394a90a7692 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Sweet Mint Splash ETHYL ALCOHOL MY IMPORTS USA LLC 4dd010e2-7bcf-666f-e063-6294a90a4f3c 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Vanilla Swirl ETHYL ALCOHOL MY IMPORTS USA LLC 4dd01f13-5ea3-7744-e063-6294a90a124f 2026-03-24 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Raspberry Lemonade ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4daa1aed-d763-2098-e063-6394a90a704b 2026-03-23 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon Cream ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4daa4b88-0ea3-2143-e063-6294a90a69ce 2026-03-23 Warnings Exact identifier application number: M003 povidine iodine POVIDINE IODINE Dynarex Corporation 564ec54b-353e-45a8-85e8-a39f89488d9c 2026-03-23 Warnings Exact identifier application number: M003 DURMA DynaWound Cleanser WOUND CLEANSER Dynarex Corporation 6a4dd82a-6b06-426b-9afd-415a1a4339b4 2026-03-23 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Sweet Mint Splash ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4dbc68be-558b-03f0-e063-6394a90aa90d 2026-03-23 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Vanilla Swirl ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 4dbc8688-f34b-1178-e063-6394a90a0e67 2026-03-23 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