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 94 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Englewood Amenity BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 7c9ce1bf-6aa2-4073-ad09-2ddf845102a2 2024-12-17 Warnings Exact identifier application number: M003 Mentholatum Moisturizing Hand Sanitizer BENZALKONIUM CHLORIDE The Mentholatum Company 365c93bc-2299-4e69-ba3a-69414bfe78d7 2024-12-13 Warnings Exact identifier application number: M003 Curaplex Alcohol Prep Pad ISOPROPYL ALCOHOL Sarnova, Inc. da1a4baa-05eb-4a75-82bb-39c547daef64 2024-12-12 Warnings Exact identifier application number: M003 Foaming Hand Sanitizer ALCOHOL Empack Spraytech Inc. 8bb072f2-9cd4-499d-9d7f-7166451b8f20 2024-12-12 Warnings Exact identifier application number: M003 Extra Stength Hand Sanitizer Zytec Germ Buster ALCOHOL 80%W/W Empack Spraytech Inc. da854195-3a50-4fae-a5ea-183bf524c973 2024-12-12 Warnings Exact identifier application number: M003 Zytec Hand Sanitizer Wipes 80% w/w Alcohol ALCOHOL Empack Spraytech Inc. ab86fd0c-40cd-0bb6-e053-2a95a90a76e2 2024-12-12 Warnings Exact identifier application number: M003 Dermoplast Kids First Aid BENZETHONIUM CHLORIDE AND BENZOCAINE Advantice Health, LLC. 29a18018-5214-4080-ac40-e646319e95ce 2024-12-12 Warnings Exact identifier application number: M003 New Skin Bandage BENZETHONIUM CHLORIDE Advantice Health, LLC. 5846f414-8329-4034-b99f-92721bdb3d14 2024-12-12 Warnings Exact identifier application number: M003 CVS Hand Sanitizer ALCOHOL CVS b5faeb31-67c7-2000-e053-2995a90a1409 2024-12-10 Warnings Exact identifier application number: M003 NEXXGEN 70% RUBBING ALCOHOL with Wintergreen ISOPROPYL ALCOHOL A & A Nexxgen LLC 8d1a5c98-8169-4f40-8601-a6f6bbbbebe7 2024-12-09 Warnings Exact identifier application number: M003 NEXXGEN 91% RUBBING ALCOHOL with Wintergreen ISOPROPYL ALCOHOL A & A Nexxgen LLC 12b8c85a-da0c-47a1-9531-c9f2858c4f31 2024-12-09 Warnings Exact identifier application number: M003 NEXXGEN 91% RUBBING ALCOHOL ISOPROPYL ALCOHOL A & A Nexxgen LLC 609267da-3ee6-4bd3-aecf-610d9047774c 2024-12-09 Warnings Exact identifier application number: M003 Isopropyl Alcohol ISOPROPYL ALCOHOL Sarnova, Inc. 62be13a6-da24-4ab0-b0f4-f2894324c20c 2024-12-06 Warnings Exact identifier application number: M003 Instant Hand Antiseptic ALCOHOL ASP Global b84075db-be0c-4265-b262-825bc6ade9d8 2024-12-06 Warnings Exact identifier application number: M003 Instant Hand Antiseptic BENZALKONIUM CHLORIDE ASP Global 47276148-08e5-400e-94ac-d2d9db423b51 2024-12-06 Warnings Exact identifier application number: M003 Instant Hand Antiseptic ALCOHOL ASP Global 9aca3f89-cdde-430c-8eb6-43a3ac3fc0df 2024-12-06 Warnings Exact identifier application number: M003 Instant Hand Antiseptic BENZALKONIUM CHLORIDE ASP Global 4eef4b0f-9209-45a4-8a0e-7891fc380fe5 2024-12-05 Warnings Exact identifier application number: M003 MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 1.5 BENZETHONIUM CHLORIDE Yangzhou H&R Plastic Daily Chemical Co., Ltd. 2998b2bd-6208-4cb4-982b-0ffb97d7d75d 2024-12-05 Warnings Exact identifier application number: M003 MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 0.5 BENZETHONIUM CHLORIDE Yangzhou H&R Plastic Daily Chemical Co., Ltd. 68003c71-5959-476f-b252-1f131e9305e2 2024-12-05 Warnings Exact identifier application number: M003 MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 3 BENZETHONIUM CHLORIDE Yangzhou H&R Plastic Daily Chemical Co., Ltd. e35e468a-1f0c-4a3f-ac6a-cd55a72f3cc2 2024-12-05 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