FDA.reportPublic FDA data

XtraCare Instant Hand Sanitizer

Product NDC
57337-059
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
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 Instant Hand Sanitizer
Listing expiration
2027-12-31

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 51 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dceced03-eeb8-fced-e053-2995a90afd5c2025-12-06WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dced643b-96fb-193f-e053-2a95a90a16aa2025-12-06WarningsExact identifier
application number: M003
Betadine Foam CleanserBENZALKONIUM CHLORIDEAtlantis Consumer Healthcare, Inc.3be9fa6e-3ae8-496b-876b-f81f1cd98af42025-12-05WarningsExact identifier
application number: M003
2XL Mega Rolls Sanitizing WipesBENZALKONIUM CHLORIDE2xl Corporation9da541ab-6836-4149-a86d-3b2f2e5866282025-12-05WarningsExact identifier
application number: M003
Hand WipesBENZALKONIUM CHLORIDEAdvanced Ultrasound Solutions Inc.2c2abaa8-c152-470b-a4d9-5056815a19872025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLCd3d95355-3af7-43e3-e053-2a95a90a0fa42025-12-05WarningsExact identifier
application number: M003
Giant Eagle Antibacterial Hand WipesBENZALKONIUM CHLORIDEGiant Eaglee20e9a93-03c3-77f8-e053-2995a90ae59f2025-12-05WarningsExact identifier
application number: M003
Antibacterial WipesBENZALKONIUM CHLORIDEERC Acquisition, Incdc6c39af-447c-481a-98b5-33b8f09b83bc2025-12-05WarningsExact identifier
application number: M003
Sanitex Antibacterial Hand Wipes Fresh ScentBENZALKONIUM CHLORIDEPrecare Corp48907146-ca66-46e1-928b-a8f968a6bff82025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideANTIBACTERIAL HAND WIPESQuest USA Corpd9ab219d-07e3-2019-e053-2a95a90a16682025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideDUAL ACTION ANTIBACTERIAL WIPESAvro Enterprises LLCcf42e470-19c8-2e11-e053-2995a90ae90d2025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideDUAL ACTION ANTIMICROBIAL WIPESAvro Enterprises LLCcf4680f4-24b2-1242-e053-2a95a90a93742025-12-05WarningsExact identifier
application number: M003
Benzalkonium ChlorideANTIBACTERIAL HAND WIPESTarget Corporationf6037707-c6bb-11a0-e053-2995a90acce82025-12-05WarningsExact identifier
application number: M003
Sanitizing WipesBENZALKONIUM CHLORIDEZogics, LLC2cd916ee-dc6d-49e4-a9b5-06ad4b2b054d2025-12-05WarningsExact identifier
application number: M003
GELLE-N-DETOX - LAVENDER AND ROSEMARY MASSAGEBENZALKONIUM CHLORIDECHEMCO CORPORATIONf28c2c1e-7d0a-45b9-e053-2995a90a47102025-12-05WarningsExact identifier
application number: M003
GELLE-N-DETOX ICE MINT AND EUCALYPTUS MASSAGEBENZALKONIUM CHLORIDECHEMCO CORPORATIONf2a107aa-5ad3-7bad-e053-2a95a90a1d972025-12-05WarningsExact identifier
application number: M003
PROHEAL POVIDONE IODINE SWABSTICKPOVIDONE-IODINEClick Industries LLC974e1205-01ab-4599-9229-cdf5225d268a2025-12-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Jasmine GardeniaALCOHOLShenzhen Lantern Scicence Co.,Ltd.45082749-6f53-c595-e063-6294a90ac3e92025-12-03WarningsExact identifier
application number: M003
ALCOHOL PREP PAD70% ISOPROPY ALCOHOL SWABPurCel Labs LLC450c39fd-d172-492e-e063-6294a90aa3962025-12-03WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERDynarex Corporation450e56f0-b8ae-072a-e063-6394a90a2d4b2025-12-03WarningsExact 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
57337-059-015733700590160 g in 1 PACKAGE60 gHistorical
57337-059-02573370059022 PACKAGE in 1 PACKAGE (57337-059-02) / 60 g in 1 PACKAGE (57337-059-01) 2 package2014-02-180000-00-00NoNoCurrent