FDA.reportPublic FDA data

XtraCare Hand Sanitizer

Product NDC
57337-043
Requested package NDC
57337-043-01
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 104 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safly BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.5cd9043e-daf2-43eb-9568-54775fc4f84a2024-05-15WarningsExact identifier
application number: M003
Noshinku Bergamot Hand SanitizerALCOHOLNoshinku53fea81e-4482-6fae-e054-00144ff8d46c2024-05-14WarningsExact identifier
application number: M003
Noshinku Eucalyptus Hand SanitizerALCOHOLNoshinku9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c02024-05-14WarningsExact identifier
application number: M003
Noshinku Lavender Hand SanitizerALCOHOLNoshinkua57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf2024-05-14WarningsExact identifier
application number: M003
LEADER 2% Mild Iodine TinctureIODINE AND SODIUM IODIDE AND ALCOHOL LIQUIDCardinal Health, 110 dba Leader7f810b92-60f6-2f72-e053-2991aa0ab9732024-05-13WarningsExact identifier
application number: M003
Leader Decolorized IodineALCOHOL LIQUIDCardinal Health, 110 dba Leader822f6f28-956f-dd82-e053-2991aa0ae7522024-05-13WarningsExact identifier
application number: M003
Inverness Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a2995-334c-2e93-e063-6294a90aecf72024-05-09WarningsExact identifier
application number: M003
Helzberg Diamonds Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a3776-0edd-26f3-e063-6294a90a740d2024-05-09WarningsExact identifier
application number: M003
Ulta Beauty Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a37f4-8718-3e40-e063-6294a90acaad2024-05-09WarningsExact identifier
application number: M003
Guardian VaginalBENZALKONIUM CHLORIDEEastern Century Pharmaceuticals1605ba44-02b7-4c72-9fec-89a5aa962b442024-04-24WarningsExact identifier
application number: M003
Inverness Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.0ccd72e7-16a2-47c7-9ce6-dffb63a0344b2024-04-18WarningsExact identifier
application number: M003
Lovisa Piercing Care SolutionBENZALKONIUM CHLORIDEThe Richline Group, Inc.74f46b81-cc5b-4e3f-a36e-0bd86d370c222024-04-18WarningsExact identifier
application number: M003
CliniClean BZK Cleansing Contains Benzalkonium ChlorideBENZALKONIUM CHLORIDEHR HealthCareb6916466-0931-408f-a430-0797a449c32e2024-04-18WarningsExact identifier
application number: M003
Handy Solutions First Aid KitBENZALKONIUM CHLORIDENavajo Manufacturing Company Inc.130237ff-3db4-1288-e063-6394a90ab1af2024-04-16WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEHenry Schein Inc.ff877b63-fa58-4770-a882-694eda33203b2024-04-02WarningsExact identifier
application number: M003
First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine HydrochlorideBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.8e1f35ff-d4e6-4940-ad8f-dce2b73e595d2024-04-01WarningsExact identifier
application number: M003
Antiseptic Towelette TOALLITAS ANTISEPTICASBENZALKONIUM CHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.b267e186-cf7a-458f-9c28-a48a8554af402024-04-01WarningsExact identifier
application number: M003
Antiseptic Povidone Iodine Prep PadPOVIDONE-IODINEM-star (Hubei) Health&Care Products Co., Ltd.fc76c1f3-b48e-4276-890d-5b8e5a894e622024-04-01WarningsExact identifier
application number: M003
Novex Hand SanitizerBENZALKONIUM CHLORIDENatural Essentials, Inc.8b53dde5-c9f6-41c4-8ddb-bf0bf67008d32024-03-20WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDE 0.13%Trifecta Pharmaceuticals USA, LLC.13f1c70f-3b44-8eef-e063-6294a90af6342024-03-18WarningsExact 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