FDA.reportPublic FDA data

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
IngredientStrength
TRICLOSAN10 mg/500mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4NM5039Y5XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
413246Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
23ff5450-8308-41c0-9052-1ac4c4433d6cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-016-012024-02-29C16284748780-11030e365-4af0-111a-e063-dadaa90a10e2Liquid Hand Cleanse
57337-016-012024-01-30C16284748780-11030e365-4af0-111a-e063-dadaa90a10e2Liquid Hand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-016-01Liquid Hand Cleanse500 mg in 1 BOTTLEGEL5003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XLIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]1
TRICLOSANACTIVE MOIETY4NM5039Y5XLIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]1
CETETH-7INACTIVE INGREDIENT4ST6952Q67LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LLIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]1
DIETHANOLAMINEINACTIVE INGREDIENTAZE05TDV2VLIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]1
ETHYL SULFATEINACTIVE INGREDIENTP3LK0HF3B7LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MLIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]1
OCTHILINONEINACTIVE INGREDIENT4LFS24GD0VLIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-016LIQUID HAND CLEANSE (TRICLOSAN) GEL [REJOICE INTERNATIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20240301_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 83 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XTRABENZALKONIUM CHLORIDEMY IMPORTS USA LLC27f4ff15-5480-8842-e063-6294a90ad35b2025-03-06WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f982aef-4f46-aa85-e063-6394a90a52b12025-03-05WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLUniversal Distribution Center LLC2f9846ce-37ca-a95b-e063-6294a90ad2602025-03-05WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC2f988951-39e7-ec02-e063-6294a90aaad72025-03-05WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f98a900-6c7c-0161-e063-6294a90ac6752025-03-05WarningsExact identifier
application number: M003
3 Hydrogen PeroxideHYDROGEN PEROXIDEUniversal Distribution Center LLC2f98ba8c-0ab1-e256-e063-6394a90abe8f2025-03-05WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2f800ea4-b8bb-0cb4-e063-6294a90a7e232025-03-04WarningsExact identifier
application number: M003
Thera Plus Pain Relief CleansingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.513a620e-f69a-488d-8abc-36e2efccdc132025-03-04WarningsExact identifier
application number: M003
Clorox Hand SanitizerALCOHOLBrand Buzz LLCbdd47d2f-5332-1430-e053-2a95a90a1c332025-03-03WarningsExact identifier
application number: M003
T/T WAG Hand Sanitizer Mist Watermelon 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2f7c4066-3baa-25f2-e063-6394a90a00eb2025-03-03WarningsExact identifier
application number: M003
Procure Products Hand Sanitizing WipesALCOHOL 70% ANTIBACTERIAL WIPESTWIN MED LLC1f378bee-88f7-14cf-e063-6394a90a48882025-02-28WarningsExact identifier
application number: M003
Instant Hand SanitizerINSTANT HAND SANITIZERRaining Rose, Inc2f37a2a1-5250-4052-e063-6294a90aef7f2025-02-28WarningsExact identifier
application number: M003
Signature Care Advanced Hand Sanitizer with AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.a20c821a-80d9-499c-aecd-3cf4d8e025902025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.d5d0badb-5e1b-4ea8-bea2-0e8cf714b69e2025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand Sanitizer with AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.f2309f34-a1ee-44c7-b818-7384de64d27b2025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.dcfc08a0-ecd6-42d3-9ff2-e68d5317152f2025-02-27WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 46122c47986e9-c851-491b-817e-fd3e0b054cd42025-02-26WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 4612200737139-bab8-40be-ad85-32526b5eab102025-02-26WarningsExact identifier
application number: M003
AUM Alcohol PadALCOHOL PADSLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS632da1b7-70bb-467d-81b2-39536f9fff3c2025-02-26WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLUniversal Synergetics, Inc0dd6884c-935f-4523-b19a-201b7a8666fc2025-02-24WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413246triclosan 0.2 % Medicated Liquid SoapPSN23ff5450-8308-41c0-9052-1ac4c4433d6c3
413246triclosan 2 MG/ML Medicated Liquid SoapSCD23ff5450-8308-41c0-9052-1ac4c4433d6c3
413246triclosan 0.2 % Medicated Liquid SoapSY23ff5450-8308-41c0-9052-1ac4c4433d6c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-016-0157337001601500 mg in 1 BOTTLE (57337-016-01) 500 mg2013-07-050000-00-00NoNoCurrent