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 61 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Meijer Hand Sanitizer Lakeshore Fresh ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 41533b69-05e7-d5f7-e063-6294a90a2d2b 2025-10-16 Warnings Exact identifier application number: M003 Meijer Hand Sanitizer Pine Forest ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 4153ac2a-e51c-f167-e063-6394a90a80d8 2025-10-16 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer Watermelon ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 412e961a-b7d4-b1c2-e063-6294a90a6b85 2025-10-15 Warnings Exact identifier application number: M003 equate First Aid Antiseptic POVIDONE-IODINE Walmart Inc. 43bbedec-be30-482a-8552-949b13d4bea1 2025-10-14 Warnings Exact identifier application number: M003 Tridergel BENZALKONIUM CHLORIDE Trifluent Pharma LLC f12d9e8c-1d69-49d9-a9e9-a392c681aa6c 2025-10-13 Warnings Exact identifier application number: M003 Be Smart Get Prepared Sting Relief Wipe BENZOCAINE, ALCOHOL Total Resources International, Inc 5415073f-aa1d-4ed3-aa30-7470cd2efed1 2025-10-10 Warnings Exact identifier application number: M003 Lemyn Organics Medical-Grade Hand Sanitizer ALCOHOL Lemyn LLC b106289d-346a-74df-e053-2995a90aa426 2025-10-10 Warnings Exact identifier application number: M003 Dr Lift Antibacterial Body Wash BENZALKONIUM CHLORIDE Spa de Soleil ab9dde33-1bd2-062f-e053-2a95a90a4d18 2025-10-10 Warnings Exact identifier application number: M003 Dr Lift Antibacterial BENZALKONIUM CHLORIDE Spa de Soleil af89675e-e66f-0922-e053-2995a90ab9d2 2025-10-10 Warnings Exact identifier application number: M003 ANTISEPTIC WIPE 01 BENZALKONIUM CHLORIDE Total Resources International Inc. cf4a6a97-529e-7f11-e053-2a95a90a75a9 2025-10-10 Warnings Exact identifier application number: M003 Be Smart Get Prepared Sting Relief Wipe ALCOHOL, LIDOCAINE HYDROCHLORIDE Total Resources International, Inc fff6f057-739e-40f1-8427-e1364c65af05 2025-10-09 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL Zhejiang Hudson Import& Export Co., Ltd 40b6c96c-e36f-6588-e063-6394a90adb46 2025-10-09 Warnings Exact identifier application number: M003 Curad ISOPROPYL ALCOHOL Medline Industries, LP c42de981-4e3f-1ac9-e053-2995a90aea98 2025-10-09 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL Avaria Health & Beauty Corp a3d87ef6-752b-b54b-e053-2a95a90af963 2025-10-08 Warnings Exact identifier application number: M003 Iodo Blanco (Iodine Tincture Decolorized) First Aid Antiseptic IODINE 2% Germa Products, LLC bf54254f-2ef3-102e-e053-2995a90ac083 2025-10-08 Warnings Exact identifier application number: M003 MediChoice BZK Antiseptic BENZALKONIUM CHLORIDE O&M HALYARD, INC. 82a7710d-a9fa-4f68-8322-046a765ae929 2025-10-08 Warnings Exact identifier application number: M003 MediChoice Cleansing BENZALKONIUM CHLORIDE O&M HALYARD, INC. 79d41cf0-301f-44d4-a76c-f4850c7ddce9 2025-10-08 Warnings Exact identifier application number: M003 MediChoice Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL O&M HALYARD, INC. 8b84c8ed-040e-4c07-94cb-d5bdda744648 2025-10-08 Warnings Exact identifier application number: M003 MediChoice of Hydrogen Peroxide 3 10 Volume HYDROGEN PEROXIDE O&M HALYARD, INC. 34e77ef4-297d-4362-8f6e-abf80158b7f0 2025-10-08 Warnings Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE O&M HALYARD, INC. 0ad5990a-a18d-4753-826b-6da313926698 2025-10-08 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