Home NDC 57337-016-01 Liquid Hand Cleanse
Product NDC 57337-016
Requested package NDC 57337-016-01
11-digit product format 573370016
Labeler code 57337
Product ID 57337-016_126c392a-2f25-cd97-e063-6294a90a4f99
Type HUMAN OTC DRUG
Nonproprietary name Triclosan
Dosage form GEL
Route TOPICAL
Labeler Rejoice International, Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-07-05
Substance TRICLOSAN
Active strength 10 mg/500mg
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 Liquid Hand Cleanse
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRICLOSAN 10 mg/500mg
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 413246 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 57337-016-01 Liquid Hand Cleanse 500 mg in 1 BOTTLE GEL 500 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRICLOSAN ACTIVE INGREDIENT 4NM5039Y5X LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.] 1 TRICLOSAN ACTIVE MOIETY 4NM5039Y5X LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.] 1 CETETH-7 INACTIVE INGREDIENT 4ST6952Q67 LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.] 1 COCONUT OIL INACTIVE INGREDIENT Q9L0O73W7L LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.] 1 DIETHANOLAMINE INACTIVE INGREDIENT AZE05TDV2V LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.] 1 ETHYL SULFATE INACTIVE INGREDIENT P3LK0HF3B7 LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.] 1 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.] 1 OCTHILINONE INACTIVE INGREDIENT 4LFS24GD0V LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-016 LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240301_23ff5450-8308-41c0-9052-1ac4c4433d6c.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 57337-016-01 57337001601 500 mg in 1 BOTTLE (57337-016-01) 500 mg 2013-07-05 0000-00-00 No No Current