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 50 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
finipil 4 men onlyBENZETHONIUM CHLORIDEEquibal, Inc.aba2e3e6-6047-416d-8ca3-44f1033671e32025-12-17WarningsExact identifier
application number: M003
finipil pro/elecBENZETHONIUM CHLORIDEEquibal, Inc.f68aa5db-7a4e-410f-8159-3356d9407d312025-12-17WarningsExact identifier
application number: M003
Made for MenBENZETHONIUM CHLORIDEEquibal, Inc.d12f748d-7dc5-4cd7-9718-ebb47171d58b2025-12-17WarningsExact identifier
application number: M003
QuickMendBENZETHONIUM CHLORIDEEquibal, Inc.9b0c85a4-9727-4940-a934-0b81a7c938cf2025-12-17WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCVS PHARMACY, INC4f628fbd-e213-43ac-9699-d678331f37652025-12-17WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLDynarex Corporation39b20f1b-8d2f-4fa0-8cb9-10cad408e0642025-12-16WarningsExact identifier
application number: M003
finipil Lait 50BENZETHONIUM CHLORIDEEquibal, Inc.bc630fbc-e428-4d46-8330-fb6f699943fd2025-12-16WarningsExact identifier
application number: M003
PS-2205 BZK Antiseptic TowelettesPS-2205 BZK ANTISEPTIC TOWELETTESProStat First Aid LLC00772636-8265-a937-e063-6294a90a438a2025-12-15WarningsExact identifier
application number: M003
PS-2362 Hand Sanitizer 0.9g packetPS-2362 HAND SANITIZER 0.9G PACKETProStat First Aid LLC01c87dff-57e0-017a-e063-6394a90a16002025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESProStat First Aid LLC0e120fed-3225-520b-e063-6394a90a9f9e2025-12-15WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERProstat First Aid LLC0e241343-db64-3f1c-e063-6394a90ab5382025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESFront Line Safety0e0ca589-834b-495b-e063-6394a90afbd02025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0e0dd88e-62eb-02c8-e063-6394a90a63d82025-12-15WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERProStat First Aid LLC0e21f466-d6ed-79c4-e063-6394a90ae9882025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0dfd48bb-3353-6062-e063-6294a90af6282025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESFront Line Safety0e1f3653-d75e-9c9e-e063-6294a90ab6392025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0e0ef369-a0e7-5320-e063-6394a90a353f2025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESProStat First Aid LLC0e11238b-e5f2-075f-e063-6394a90aa8252025-12-15WarningsExact identifier
application number: M003
3% HYDROGEN PEROXIDEHYDROGEN PEROXIDEUniversal Distribution Center LLC53573a9c-bddc-49ea-931e-4779a20eb14f2025-12-15WarningsExact identifier
application number: M003
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd3aab4b75-7a52-46b1-e063-6294a90a72532025-12-14WarningsExact 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