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#

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 101 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antiseptic Povidone-lodine Prep PadPOVIDONE-IODINEHubei Changjian Medical Products Co., Ltd.2cacf2e0-0192-4e0f-88a6-e3eee3af54712024-10-11WarningsExact identifier
application number: M003
AntisepticETHANOLMcKesson6637290d-6ae4-5a83-e053-2991aa0a81c62024-10-11WarningsExact identifier
application number: M003
AntibacterialBENZETHONIUM CHLORIDEMcKesson58892abf-e0b9-83d9-e053-2a91aa0ad0352024-10-11WarningsExact identifier
application number: M003
AntibacterialBENZETHONIUM CHLORIDEMcKesson588a89cd-9481-6163-e053-2991aa0a9e3d2024-10-11WarningsExact identifier
application number: M003
McKesson Obstetrical Antiseptic ToweletteBENZALKONIUM CHLORIDEMcKesson Medical-Surgical51a3dabe-25d3-47fd-b640-83e68f7e06de2024-10-11WarningsExact identifier
application number: M003
McKesson Benzalkonium Chloride ToweletteBENZALKONIUM CHLORIDEMcKesson Medical-Surgicalcea36a9e-aac3-4494-a713-1dc64272d99c2024-10-11WarningsExact identifier
application number: M003
Alcohol Disinfecting WipeALCOHOLMcKesson Medical-Surgical64a0063d-a5da-4a46-9dca-16e4dbdac85c2024-10-11WarningsExact identifier
application number: M003
Mckesson Hand Cleanse and Soothe with AloeCHLOROXYLENOLMckesson Medical-Surgical Inc.075cd889-948a-49dd-8927-e22f7a5bff992024-10-10WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZER UNSCENTEDCASAD Company, Inc07a891a3-dcf7-438f-bbf7-a20b2aa7d7d72024-10-09WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZER UNSCENTEDCASAD Company, Inc0933de73-94b1-448e-b39f-ecffabf952882024-10-09WarningsExact identifier
application number: M003
EVERSOFT FOAMING HAND ANTI-BACTERIALCHLOROXYLENOLDraco Hygienic Products Inc.e9d4767b-21f2-b68f-e053-2995a90a5aba2024-10-08WarningsExact identifier
application number: M003
FOAMING HAND ALCOHOL FOAMALCOHOLDraco Hygienic Products Inc.14860a19-e1e8-71fc-e063-6394a90a9df82024-10-08WarningsExact identifier
application number: M003
FOAMING HAND ANTIBACTERIALCHLOROXYLENOLDraco Hygienic Products Inc.15256355-29ef-9b24-e063-6294a90a907d2024-10-08WarningsExact identifier
application number: M003
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.4d156264-566d-4516-876c-b6f5823a97f52024-10-04WarningsExact identifier
application number: M003
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.9d3a4dfe-f31d-4def-bfc2-ece69d13f8e42024-10-04WarningsExact identifier
application number: M003
DiaSincBENZALKONIUM CHLORIDEPureTek Corporationd9ba1ca8-8883-11bb-e053-2995a90a58462024-10-02WarningsExact identifier
application number: M003
GenRx Hand SanitizingBENZALKONIUM CHLORIDEPureTek Corporationa12715c0-77f2-7716-e053-2995a90a06d32024-10-02WarningsExact identifier
application number: M003
Model AA-2012MODEL AA-2012AEROSPACE ACCESSORY SERVICEe29b0f92-27b7-e09f-e053-2995a90a35e32024-10-01WarningsExact identifier
application number: M003
Hand Sanitizer Zytec Germ BusterALCOHOL 70%V/VEmpack Spraytech Inc.f8f17337-6eac-465f-b961-3fec1c3c0f1f2024-09-20WarningsExact identifier
application number: M003
WalmartISOPROPYL ALCOHOLWalmart Inc.d2b9f182-c341-c3b0-e053-2a95a90ac5a72024-09-18WarningsExact 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