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 101 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hand Sanitizer HAND SANITIZER UNSCENTED CASAD Company, Inc 0933de73-94b1-448e-b39f-ecffabf95288 2024-10-09 Warnings Exact identifier application number: M003 EVERSOFT FOAMING HAND ANTI-BACTERIAL CHLOROXYLENOL Draco Hygienic Products Inc. e9d4767b-21f2-b68f-e053-2995a90a5aba 2024-10-08 Warnings Exact identifier application number: M003 FOAMING HAND ALCOHOL FOAM ALCOHOL Draco Hygienic Products Inc. 14860a19-e1e8-71fc-e063-6394a90a9df8 2024-10-08 Warnings Exact identifier application number: M003 FOAMING HAND ANTIBACTERIAL CHLOROXYLENOL Draco Hygienic Products Inc. 15256355-29ef-9b24-e063-6294a90a907d 2024-10-08 Warnings Exact identifier application number: M003 Germ Attack Hand Sanitizer ALCOHOL Natural Essentials, Inc. 4d156264-566d-4516-876c-b6f5823a97f5 2024-10-04 Warnings Exact identifier application number: M003 Germ Attack Hand Sanitizer ALCOHOL Natural Essentials, Inc. 9d3a4dfe-f31d-4def-bfc2-ece69d13f8e4 2024-10-04 Warnings Exact identifier application number: M003 DiaSinc BENZALKONIUM CHLORIDE PureTek Corporation d9ba1ca8-8883-11bb-e053-2995a90a5846 2024-10-02 Warnings Exact identifier application number: M003 GenRx Hand Sanitizing BENZALKONIUM CHLORIDE PureTek Corporation a12715c0-77f2-7716-e053-2995a90a06d3 2024-10-02 Warnings Exact identifier application number: M003 Model AA-2012 MODEL AA-2012 AEROSPACE ACCESSORY SERVICE e29b0f92-27b7-e09f-e053-2995a90a35e3 2024-10-01 Warnings Exact identifier application number: M003 Hand Sanitizer Zytec Germ Buster ALCOHOL 70%V/V Empack Spraytech Inc. f8f17337-6eac-465f-b961-3fec1c3c0f1f 2024-09-20 Warnings Exact identifier application number: M003 Walmart ISOPROPYL ALCOHOL Walmart Inc. d2b9f182-c341-c3b0-e053-2a95a90ac5a7 2024-09-18 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL Strategic Sourcing Services LLC 2216a551-9fbe-3721-e063-6294a90af13d 2024-09-14 Warnings Exact identifier application number: M003 Danielle Creations Hand Sanitizer - Strawberry ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. 7c4bab88-af65-48c2-8440-3ba7b139c013 2024-09-10 Warnings Exact identifier application number: M003 Danielle Creations Hand Sanitizer - Apple ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. 362d3233-79ac-41d8-9991-b5fc75c6cae9 2024-09-10 Warnings Exact identifier application number: M003 Danielle Creations Hand Sanitizer - Peach ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. ad28fe19-2b81-40c2-8ffb-f9b09c79def8 2024-09-10 Warnings Exact identifier application number: M003 Thompson Antiseptic BENZALKONIUM CHLORIDE Thompson 0c009ed0-23b8-e4b3-e063-6394a90a723d 2024-09-04 Warnings Exact identifier application number: M003 Bravo Sierra - Antibacterial Body Wipes BENZALKONIUM CHLORIDE WIPES Underscore USA 20ed5566-9014-e35b-e063-6294a90a003a 2024-08-30 Warnings Exact identifier application number: M003 BERRIS AND CREAMY SCENTED HAND SANITIZER ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. 30fc7f33-238c-42a3-93a1-72b98d303d9a 2024-08-28 Warnings Exact identifier application number: M003 MANGO SORBET SCENTED HAND SANITIZER ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. d44e43e1-717d-47a1-a152-45f12288cbd2 2024-08-28 Warnings Exact identifier application number: M003 COCONUT VANILLA SCENTED HAND SANITIZER ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. 574324ee-d98b-4939-889c-21ed04a4e46d 2024-08-28 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