Home NDC 57337-021-01 XtraCare Antibacterial Hand Cleanse
Product NDC 57337-021
Requested package NDC 57337-021-01
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 106 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join XtraCare Hand Sanitizer Moisurize with Vitamin E and Aloe ETHYL ALCOHOL Rejoice International 2851ad2a-e108-424c-86d6-c898567695ef 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Hand Sanitizer Moisturize with Vitamin E ETHYL ALCOHOL Rejoice International 13c99570-0859-4310-843a-5eb266698eb3 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Instant Hand Sanitizer ETHYL ALCOHOL Rejoice International a339dfd9-7cb8-4198-bc2a-9759648cf34e 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Instant Hand Sanitizer ETHYL ALCOHOL Rejoice International f15a90e2-4a1e-452a-b9ac-5eb6f7b3dc72 2024-02-28 Warnings Exact identifier application number: M003 AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZER ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd 11ef87cc-6ff6-511b-e063-6294a90a662f 2024-02-21 Warnings Exact identifier application number: M003 AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZER ETHYL ALCOHOL MY IMPORTS USA LLC 11f19126-6abb-b14c-e063-6294a90a4e34 2024-02-21 Warnings Exact identifier application number: M003 Antiseptic ANTISEPTIC SPRAY Dynarex Corporation 118192ac-7173-09c5-e063-6394a90ad550 2024-02-16 Warnings Exact identifier application number: M003 Isopropyl Alcohol ISOPROPYL ALCOHOL SPRAY Dynarex Corporation 116e0c9c-cbe0-bf67-e063-6394a90ae530 2024-02-15 Warnings Exact identifier application number: M003 POVIDONE-IODINE POVIDONE-IODINE HART Health 92b6a38e-c7bb-45e2-9c2a-7993ed1bac36 2024-02-15 Warnings Exact identifier application number: M003 Povidone Iodine Gel Swabstick POVIDONE IODINE GEL SWABSTICK Dynarex Corporation eb7e21be-521e-2d52-e053-2a95a90ade33 2024-02-13 Warnings Exact identifier application number: M003 Antiseptic ALCOHOL, LIDOCAINE HYDROCHLORIDE Safetec of America, Inc. 71aeaf86-2b4d-4945-9606-a9db0ab6b726 2024-02-07 Warnings Exact identifier application number: M003 Antiseptic BENZALKONIUM CHLORIDE, BENZOCAINE Safetec of America, Inc. 458e65f2-826d-4550-8c7d-17add2d7ba9a 2024-02-07 Warnings Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE Safetec of America, Inc. a665e2ce-c7e1-4d79-aa58-da7595944e7f 2024-02-07 Warnings Exact identifier application number: M003 First Aid and Burn BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE Safetec of America, Inc. 47cb6921-5d82-4123-a9e0-0b05d4dcb5b2 2024-02-07 Warnings Exact identifier application number: M003 Hand sanitizer 8oz with vitamin E ETHYL ALCOHOL 70%V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 0fbf0078-3660-fe5c-e063-6394a90afc2d 2024-01-25 Warnings Exact identifier application number: M003 Hand sanitizer 8oz with aloe vera ETHYL ALCOHOL 70%V/V Midwood Brands, LLC 0fc032af-26bc-0e8b-e063-6294a90a91b0 2024-01-25 Warnings Exact identifier application number: M003 Hand sanitizer 16.9oz with vitamin E ETHYL ALCOHOL Midwood Brands, LLC 0fc0bd79-ddd7-b9d1-e063-6394a90adc69 2024-01-25 Warnings Exact identifier application number: M003 Hand sanitizer 8oz with vitamin E ETHYL ALCOHOL 70%V/V Midwood Brands, LLC 0fc0970d-06a6-ade9-e063-6394a90ae7ff 2024-01-25 Warnings Exact identifier application number: M003 Target Up and Up Pain Relieving Cleansing BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE TARGET CORPORATION 0f964747-be02-c715-e063-6294a90ad91e 2024-01-25 Warnings Exact identifier application number: M003 SannyTize Hand Sanitizer HAND SANITIZER Dynarex Corporation 968713a5-64d3-86fc-e053-2995a90a088a 2024-01-24 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