Home NDC 57337-069 XtraCare Antibacterial Hand Cleanse
Product NDC 57337-069
11-digit product format 573370069
Labeler code 57337
Product ID 57337-069_2decfde9-cfb3-3dbb-e063-6294a90aac46
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 57337-069-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 57337-069-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 57337-069-01 0efc9e666f02…f202fb6c5f17…
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 Fresh Citrus
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 57337-069-01 XtraCare Antibacterial Hand CleanseFresh Citrus 221 mL in 1 BOTTLE SOAP 221 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRICLOSAN ACTIVE INGREDIENT 4NM5039Y5X XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 1 TRICLOSAN ACTIVE MOIETY 4NM5039Y5X XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 1 COCO DIETHANOLAMIDE INACTIVE INGREDIENT 92005F972D XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 1 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 1 METHYLCHLOROISOTHIAZOLINONE INACTIVE INGREDIENT DEL7T5QRPN XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 1 PEG-150 DISTEARATE INACTIVE INGREDIENT 6F36Q0I0AC XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 1 SODIUM C14-16 OLEFIN SULFONATE INACTIVE INGREDIENT O9W3D3YF5U XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 1 SODIUM LAURETH SULFATE INACTIVE INGREDIENT BPV390UAP0 XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-069 XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20250214_e87ef6e6-ef41-43c4-bfdf-b7e3446436b7.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 69 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Povidone Iodine Prep POVIDONE IODINE Sion Biotext Medical Ltd e05af551-647d-4278-bb7f-86f888ddbb8b 2025-09-04 Warnings Exact identifier application number: M003 X3 Clean BENZALKONIUM CHLORIDE X3 Labs Inc. a8eedcfd-3b97-497a-9a34-d59b0dd78439 2025-09-03 Warnings Exact identifier application number: M003 X3 Clean BENZALKONIUM CHLORIDE X3 Labs Inc. 40cc6501-3cee-24cc-e054-00144ff88e88 2025-09-03 Warnings Exact identifier application number: M003 5OCT ANTIBACTERL HAND WIPES 5OCT ANTIBACTERL HAND WIPES Jinhua Aidi Daily Chemical Co., Ltd. 3dbd8ca9-1ca0-ac4f-e063-6394a90a3cfa 2025-09-01 Warnings Exact identifier application number: M003 AeroWipe STING RELIEF PAD Aero Healthcare US LLC 3d851c98-c9b9-f084-e063-6294a90acde2 2025-08-29 Warnings Exact identifier application number: M003 wet wipes 01 BENZALKONIUM CHLORIDE Cosmuses Cosmetics (Ningbo) Co., Ltd. 3d3d7e8b-1ec1-9f9f-e063-6294a90ade0e 2025-08-25 Warnings Exact identifier application number: M003 Solar Flare Hand Sanitizer Brazilian Caramel Dreams ALCOHOL Scent Theory Products LLC 3d0d4ccf-ea31-cab2-e063-6294a90a4c69 2025-08-23 Warnings Exact identifier application number: M003 Solar Flare Hand Sanitizer Sunset Samba ALCOHOL Scent Theory Products LLC 3d0d7d6b-33a0-5cd1-e063-6394a90ac8f6 2025-08-23 Warnings Exact identifier application number: M003 Solar Flare Hand Sanitizer Set Sea Veil, Pink Glow, Coco Creme ALCOHOL Scent Theory Products LLC 3d0d7e73-8a83-9577-e063-6294a90aff6c 2025-08-23 Warnings Exact identifier application number: M003 Burn Cream BENZALKONIUM CHLORIDE, LIDOCAINE HCI Trifecta Pharmaceuticals USA LLC fe439c60-5a02-648f-e053-6294a90a1403 2025-08-23 Warnings Exact identifier application number: M003 OP-First Aid Series ALCOHOL PREP PADS STERILE ISOPROPYL ALCOHOL CLOTH Yiwu Ori-Power Medtech Co.,Ltd. 351f4b1e-75c9-abec-e063-6294a90a2875 2025-08-22 Warnings Exact identifier application number: M003 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL Jell Pharmaceuticals Pvt. Ltd. 3cf2ff12-0220-3307-e063-6394a90abf08 2025-08-22 Warnings Exact identifier application number: M003 Chain Drug Marketing Association, Inc. ISOPROPYL ALCOHOL Chain Drug Marketing Association Inc. 18fe4787-8986-4d64-e063-6394a90a3513 2025-08-22 Warnings Exact identifier application number: M003 Scentfull Hand Sanitizer Eucalyptus Aloe ALCOHOL Scent Theory Products LLC 3cf7e175-239d-e13b-e063-6294a90a7906 2025-08-22 Warnings Exact identifier application number: M003 Scentfull Hand Sanitizer Sunrise Glow ALCOHOL Scent Theory Products LLC 3cf7fce1-3112-0d66-e063-6294a90a9865 2025-08-22 Warnings Exact identifier application number: M003 AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d7d0e8-12b4-e410-e053-2a95a90a7f30 2025-08-21 Warnings Exact identifier application number: M003 American Red Cross 3 Hydrogen Peroxide HYDROGEN PEROXIDE MY IMPORTS USA LLC de46ffc7-3b66-dd8b-e053-2a95a90a28d8 2025-08-21 Warnings Exact identifier application number: M003 Antibacterial Hand wipes BENZALKONIUM CHLORIDE MY IMPORTS USA LLC 2ba77bab-7d02-d7c7-e063-6294a90aae87 2025-08-19 Warnings Exact identifier application number: M003 SANITIZING HAND WIPES SANITIZING HAND WIPES Jinhua Aidi Daily Chemical Co., Ltd. 3cb82a83-3067-80a6-e063-6394a90a8ab0 2025-08-19 Warnings Exact identifier application number: M003 MedPride PrepPads POVIDONE IODINE Shield Line LLC 289e92a2-f03f-4b8a-e054-00144ff8d46c 2025-08-19 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 57337-069-01 57337006901 221 mL in 1 BOTTLE (57337-069-01) 221 ml 2013-09-03 0000-00-00 No No Current