FDA.reportPublic FDA data

XtraCare Hand Sanitizer

Product NDC
57337-043
11-digit product format
573370043
Labeler code
57337
Product ID
57337-043_126db003-135c-0ecb-e063-6394a90a1742
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Rejoice International
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-24
Substance
ALCOHOL
Active strength
146 g/236g
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 Hand Sanitizer
Brand name suffix
Moisturize with Vitamin E
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL146 g/236g

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
581660Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
13c99570-0859-4310-843a-5eb266698eb3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-043-012024-02-28C16284748780-11030e365-53fd-111a-e063-dadaa90a10e2XtraCare Hand Sanitizer
57337-043-012024-01-30C16284748780-11030e365-53fd-111a-e063-dadaa90a10e2XtraCare Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-043-01XtraCare Hand SanitizerMoisturize with Vitamin E236 g in 1 BOTTLEGEL2363

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MXTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1
ALCOHOLACTIVE MOIETY3K9958V90MXTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LXTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKXTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-043XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20240229_13c99570-0859-4310-843a-5eb266698eb3.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 87 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Assorted Licensed Sanitizer Hot Wheels 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfdd225-24f4-6d57-e063-6394a90a8a242025-02-12WarningsExact identifier
application number: M003
Smart Care Cucumber Melon Hand Sanitizer 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfe0ac7-99d5-aac3-e063-6294a90a31b32025-02-12WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLGood Sense (Geiss, Destin & Dunn, Inc.)ac66be77-d358-44ea-8904-88186a7c2bbb2025-02-07WarningsExact identifier
application number: M003
Rubbing Alcohol 70 Percent IsopropylISOPROPYL ALCOHOLHarris Teeter, LLC4196dd97-9041-4712-8196-02237a3b0cb22025-02-07WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLHarris Teeter, LLC1b044f47-45e1-40a3-81b0-2717ed425f162025-02-07WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e042f5b-3f0c-1830-e054-00144ff88e882025-02-06WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e04fa70-c25d-4499-e054-00144ff8d46c2025-02-06WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e05cceb-b8f3-48f7-e054-00144ff88e882025-02-06WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz AntisepticETHYL ALCOHOLREJOICE INTERNATIONAL CORP.a0313f20-11dc-6c7d-e053-2a95a90a60f12025-02-06WarningsExact identifier
application number: M003
Hand sanitizer 16.9oz with vitamin EETHYL ALCOHOL 70%REJOICE INTERNATIONAL CORP.03f869b3-3004-8b25-e063-6294a90a176e2025-02-06WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percent WintergreenISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)444cd7f4-cf61-49b6-a93e-915d250838da2025-02-06WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON VANILLIAALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d613ab9-c87b-1f3c-e063-6394a90a31202025-02-05WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COCONUTALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d6148e2-d959-6150-e063-6294a90acba52025-02-05WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER WATERMELONALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d6175c9-abe5-4c68-e063-6394a90afc362025-02-05WarningsExact identifier
application number: M003
Hand sanitizer 29ml 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.eb5d6739-ee36-cd74-e053-2a95a90ab6592025-02-05WarningsExact identifier
application number: M003
Hand sanitizer 29ml 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.037b4acb-49ca-bc0a-e063-6394a90a1fcc2025-02-05WarningsExact identifier
application number: M003
BIOPURE 50CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.ecef31dc-2f36-b578-e053-2995a90a3acd2025-02-05WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)444883fc-7ae4-4dd3-bd2b-f94c3265c1702025-02-05WarningsExact identifier
application number: M003
PHARMACIST CHOICE ALCOHOL STERILE PREP PADISOPROPYL ALCOHOLSimple Diagnostics0fc4a4b2-342b-5948-e054-00144ff88e882025-02-04WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd32055326-c229-5f10-e063-6394a90ab62c2025-02-01WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN13c99570-0859-4310-843a-5eb266698eb33
581660ethanol 0.62 ML/ML Topical GelSCD13c99570-0859-4310-843a-5eb266698eb33
581660ethanol 62 % Topical GelSY13c99570-0859-4310-843a-5eb266698eb33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-043-0157337004301236 g in 1 BOTTLE (57337-043-01) 236 g2014-01-240000-00-00NoNoCurrent