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 28 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Raspberry LemonadeETHYL ALCOHOLMY IMPORTS USA LLC4dcfcd41-b93f-accf-e063-6394a90a963d2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon CreamETHYL ALCOHOLMY IMPORTS USA LLC4dd00a64-c0bf-cf7d-e063-6394a90a76922026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sweet Mint SplashETHYL ALCOHOLMY IMPORTS USA LLC4dd010e2-7bcf-666f-e063-6294a90a4f3c2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla SwirlETHYL ALCOHOLMY IMPORTS USA LLC4dd01f13-5ea3-7744-e063-6294a90a124f2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Raspberry LemonadeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4daa1aed-d763-2098-e063-6394a90a704b2026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon CreamETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4daa4b88-0ea3-2143-e063-6294a90a69ce2026-03-23WarningsExact identifier
application number: M003
povidine iodinePOVIDINE IODINEDynarex Corporation564ec54b-353e-45a8-85e8-a39f89488d9c2026-03-23WarningsExact identifier
application number: M003
DURMA DynaWound CleanserWOUND CLEANSERDynarex Corporation6a4dd82a-6b06-426b-9afd-415a1a4339b42026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sweet Mint SplashETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4dbc68be-558b-03f0-e063-6394a90aa90d2026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla SwirlETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4dbc8688-f34b-1178-e063-6394a90a0e672026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coconut LimeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da93596-ec59-1e56-e063-6394a90afceb2026-03-22WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Island VanillaETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da951ff-37fe-4ca4-e063-6394a90a4baf2026-03-22WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pink SugarETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da9cb12-3aaf-c0f9-e063-6394a90ae4a42026-03-22WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Bellini GlowETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da8a7b6-d147-87c3-e063-6394a90a784c2026-03-22WarningsExact identifier
application number: M003
ALCOHOL PREP AWABSISOPROPYL ALCOHOL PATCHHenan Bingqing Yujie wipes Co., LTD2e67e417-4dba-73a2-e063-6294a90aa4b22026-03-20WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEAmazon.com Services LLC3e2b255c-e3b7-468c-9ac1-b63279c5ac7f2026-03-20Warnings, Adverse reactionsExact identifier
application number: M003
MediChoice OB CleansingBENZALKONIUM CHLORIDEO&M HALYARD, INC.ed38fb97-b67d-430b-8f6b-4fc78c16aead2026-03-17WarningsExact identifier
application number: M003
MedPRIDEISOPROPYL ALCOHOLShield Line LLCf2177bd3-259d-4231-88b2-4a98e48e4df62026-03-17WarningsExact identifier
application number: M003
MedPride 91% Rubbing AlcoholISOPROPYL ALCOHOLShield Line LLCe6ffe41e-efdc-0e0a-e053-2995a90a9e6a2026-03-17WarningsExact identifier
application number: M003
MedPRIDE with Wintergreen OilISOPROPYL ALCOHOLShield Line LLC57ac1a5c-758a-4422-8795-40391584434a2026-03-17WarningsExact 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