FDA.reportPublic FDA data

XtraCare Instant Hand Sanitizer

Product NDC
57337-059
Requested package NDC
57337-059-02
11-digit product format
573370059
Labeler code
57337
Product ID
57337-059_126e086f-ebda-cffb-e063-6294a90afdc5
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Rejoice International
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-18
Substance
ALCOHOL
Active strength
37 g/60g
NDC exclude flag
No
Listing certified through
2026-12-31
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 Instant Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL37 g/60g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
247835Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a339dfd9-7cb8-4198-bc2a-9759648cf34eAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-059-022024-02-28C16284748780-11030e365-3872-111a-e063-dadaa90a10e2XtraCare Instant Hand Sanitizer
57337-059-022024-01-30C16284748780-11030e365-3872-111a-e063-dadaa90a10e2XtraCare Instant Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-059-01XtraCare Instant Hand Sanitizer60 g in 1 PACKAGELIQUID604
57337-059-02XtraCare Instant Hand Sanitizer2 in 1 PACKAGELIQUID24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MXTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]2
ALCOHOLACTIVE MOIETY3K9958V90MXTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LXTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3XTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8XTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKXTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]2
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-059XTRACARE INSTANT HAND SANITIZER (ETHYL ALCOHOL) LIQUID [REJOICE INTERNATIONAL]4Current NDC, Legacy NDC, 2 package rows20240229_a339dfd9-7cb8-4198-bc2a-9759648cf34e.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 79 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Vanilla CashmereETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36b63138-8ec9-e84a-e063-6394a90a68e32025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Spearmint EucalyptusETHYL ALCOHOL 70%MY IMPORTS USA LLC36b6d0e4-8d9f-9df5-e063-6294a90af3262025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunflower HazeETHYL ALCOHOL 70%MY IMPORTS USA LLC36b71ebe-0638-73e8-e063-6394a90a9f4e2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CashmereETHYL ALCOHOL 70%MY IMPORTS USA LLC36b73e99-293a-865b-e063-6394a90a39c42025-06-03WarningsExact identifier
application number: M003
Biopure 3 Hydrogen PeroxideHYDROGEN PEROXIDEQuest USA Corp1e34d066-f82c-484c-87bf-aa54fb1fac072025-06-02WarningsExact identifier
application number: M003
Simply Saline Wound CareBENZETHONIUM CHLORIDE 0.13%Church & Dwight Co., Inc.6c802e91-b69e-cdd0-e053-2991aa0aa7812025-06-01WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd39a5a4a2-983e-a4e7-e063-6394a90aa27c2025-06-01WarningsExact identifier
application number: M003
BerbereX Wound CleanserBENZETHONIUM CHLORIDECosco International, Inc.08b28f52-21fc-4694-a163-91c8193b40082025-05-30WarningsExact identifier
application number: M003
Op-First Aid Series Povidone Iodine Prep PadPOVIDONE-IODINEYiwu Ori-Power Medtech Co.,Ltd.32dc994b-6636-72d8-e063-6294a90a98f62025-05-29WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Apple Pear CloveETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.363e549a-c432-9f2e-e063-6394a90ae8862025-05-28WarningsExact identifier
application number: M003
Quality Choice Hydrogen Peroxide WipesHYDROGEN PEROXIDEChain Drug Marketing Association, Incc2822eb6-8a2a-4337-acce-6f7fc84961752025-05-26WarningsExact identifier
application number: M003
VLITEPRO First Aid WipesISOPROPYL ALCOHOL CLOTHYiwu Ori-Power Medtech Co., Ltd.35a7873a-e340-aae3-e063-6294a90a767f2025-05-26WarningsExact identifier
application number: M003
Band Aid Antiseptic Cleansing LiquidBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEKenvue Brands LLCd2a6e0d2-5b9b-11c0-e053-2a95a90a4df02025-05-26WarningsExact identifier
application number: M003
First Aid Only Antiseptic First AidBENZALKONIUM CHLORIDEAcme United Corporation35d06b38-55dd-e306-e063-6394a90aaf262025-05-23WarningsExact identifier
application number: M003
BIOPURE20CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.359f43c7-682a-ba1c-e063-6394a90a8dcb2025-05-21WarningsExact identifier
application number: M003
Walgreens Advanced Wound WashBENZALKONIUM CHLORIDEWalgreens Co.25c6d81c-d462-5a89-e063-6294a90a08f32025-05-20WarningsExact identifier
application number: M003
Hand Sanitizer Cozy ComfortALCOHOLScent Theory Products LLC35965496-d101-c604-e063-6294a90a1a482025-05-20WarningsExact identifier
application number: M003
Hand Sanitizer Whipped ChaiALCOHOLScent Theory Products LLC35966f42-1f59-e5f5-e063-6294a90a99822025-05-20WarningsExact identifier
application number: M003
VLITEPRO BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEYiwu Ori-Power Medtech Co.,Ltd.3543d2f6-16d3-aa65-e063-6294a90a96372025-05-19WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLSafeway, Inc.29e5c152-15d7-4080-abf0-f76f8e9cbf5a2025-05-16WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
247835ethanol 62 % Topical SolutionPSNa339dfd9-7cb8-4198-bc2a-9759648cf34e4
247835ethanol 0.62 ML/ML Topical SolutionSCDa339dfd9-7cb8-4198-bc2a-9759648cf34e4
247835ethanol 62 % Topical SolutionSYa339dfd9-7cb8-4198-bc2a-9759648cf34e4
247835ethyl alcohol 62 % Topical SolutionSYa339dfd9-7cb8-4198-bc2a-9759648cf34e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-059-02573370059022 PACKAGE in 1 PACKAGE (57337-059-02) / 60 g in 1 PACKAGE (57337-059-01) 2 package2014-02-180000-00-00NoNoCurrent