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 40 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AshleyBelle Moisturizing Hand Sanitizer Blueberry Freesia ETHYL ALCOHOL MY IMPORTS USA LLC 48f0a73a-66b5-e7d0-e063-6394a90a2333 2026-01-21 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar Blossom ETHYL ALCOHOL MY IMPORTS USA LLC 48f127be-8259-5aaa-e063-6294a90a3f1a 2026-01-21 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Rose Lychee ETHYL ALCOHOL MY IMPORTS USA LLC 48f2433f-b924-ade1-e063-6394a90a2c9a 2026-01-21 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pineapple Soleil ETHYL ALCOHOL MY IMPORTS USA LLC 48f2527c-a83e-f709-e063-6394a90aa030 2026-01-21 Warnings Exact identifier application number: M003 DOP Hydrogen Peroxide 3% HYDROGEN PEROXIDE Omega & Delta Co. Inc. 73edab95-74ff-4f45-a941-634c83a52188 2026-01-21 Warnings Exact identifier application number: M003 DOP Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL Omega & Delta Co., Inc. c779a35b-1118-4560-8d77-6878edb4c267 2026-01-21 Warnings Exact identifier application number: M003 Betadine Solution POVIDONE-IODINE Atlantis Consumer Healthcare, Inc. 1b1e224c-8c00-46ea-9bdd-020a9b45321d 2026-01-21 Warnings Exact identifier application number: M003 CVS Hydrogen Peroxide Wipes HYDROGEN PEROXIDE CVS Pharmacy d2c22ab0-9647-4025-8282-6b492209b04c 2026-01-20 Warnings Exact identifier application number: M003 Hand Sanitizing Wipes ALCOHOL Germs Be Gone LLC 2bd6249b-f215-7aa9-e063-6394a90a6580 2026-01-20 Warnings Exact identifier application number: M003 SPA HAND SANITIZER SUMMER LEMON ETHYL ALCOHOL Rejoice International Corp. 48dd563a-0558-cc76-e063-6294a90ab041 2026-01-20 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Blueberry Freesia ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 48de4a31-c620-6c1c-e063-6394a90abb96 2026-01-20 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar Blossom ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 48df981a-74da-a629-e063-6294a90a7f40 2026-01-20 Warnings Exact identifier application number: M003 Scent Theory Hand Sanitizers Coastal Mist, Boardwalk Treats, Firecracker Freeze ALCOHOL Scent Theory Products LLC 48c3d5e9-2d57-5a46-e063-6394a90a0722 2026-01-19 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL Zhejiang Jinghui Cosmetics Share Co., Ltd. 487b648a-1680-6de5-e063-6394a90ab852 2026-01-16 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL Zhejiang Jinghui Cosmetics Share Co., Ltd. 487e6851-1ca3-f9db-e063-6394a90a56f1 2026-01-16 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ALCOHOL Safetec of America, Inc. c3f0556d-f967-4f19-922c-57a2bf184892 2026-01-16 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ALCOHOL Safetec of America 3b5b46d0-308a-4649-8384-246da3a18ba1 2026-01-16 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ALCOHOL Safetec of America bf69cc74-ebe9-40c3-a95a-a489492cc693 2026-01-16 Warnings Exact identifier application number: M003 NEXXGEN 50% RUBBING ALCOHOL ISOPROPYL ALCOHOL A & A Nexxgen LLC d48232ab-ab55-488a-9cc1-77c8d0ba992e 2026-01-16 Warnings Exact identifier application number: M003 hi peach layne ETHYL ALCOHOL ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD 486ee2e0-2222-0574-e063-6294a90a9eff 2026-01-15 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