FDA.reportPublic FDA data

Instant Hand Sanitizer - Clear

Product NDC
57337-014
11-digit product format
573370014
Labeler code
57337
Product ID
57337-014_126c19c0-3f4a-c537-e063-6294a90a6bbf
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Rejoice International, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-07-05
Substance
ALCOHOL
Active strength
147 mL/237mL
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
Instant Hand Sanitizer - Clear
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL147 mL/237mL

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
f0e637d9-d61e-466d-9e05-f906639dbacaAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-014-012024-02-28C16284748780-11030e365-396b-111a-e063-dadaa90a10e2Instant Hand Sanitizer - Clear
57337-014-012024-01-30C16284748780-11030e365-396b-111a-e063-dadaa90a10e2Instant Hand Sanitizer - Clear

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-014-01Instant Hand Sanitizer - Clear237 mL in 1 BOTTLEGEL2373

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MINSTANT HAND SANITIZER - CLEAR (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1
ALCOHOLACTIVE MOIETY3K9958V90MINSTANT HAND SANITIZER - CLEAR (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0INSTANT HAND SANITIZER - CLEAR (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XINSTANT HAND SANITIZER - CLEAR (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1
CARBOMER HOMOPOLYMER TYPE BINACTIVE INGREDIENTHHT01ZNK31INSTANT HAND SANITIZER - CLEAR (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXINSTANT HAND SANITIZER - CLEAR (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INSTANT HAND SANITIZER - CLEAR (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKINSTANT HAND SANITIZER - CLEAR (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RINSTANT HAND SANITIZER - CLEAR (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-014INSTANT HAND SANITIZER - CLEAR (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20240229_f0e637d9-d61e-466d-9e05-f906639dbaca.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 90 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DERMADIVE ULTRACARE - TETRAIDBENZALKONIUM CHLORIDEReleaf Technologies LLC025c0b33-73ca-334b-e063-6394a90ad6682025-01-09WarningsExact identifier
application number: M003
Drs. pharmacy triple antibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLCbb730976-0045-c0ae-e053-2a95a90af34e2025-01-09WarningsExact identifier
application number: M003
Drs. Antibiotic BacitracinBACITRACINOL PHARMA TECH, LLCc26493c4-0bc1-5fdc-e053-2995a90a81e62025-01-09WarningsExact identifier
application number: M003
Drs. Pharmacy Triple Antibiotic PlusBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACYd037bfb8-0d8c-4eda-e053-2995a90ae1f22025-01-09WarningsExact identifier
application number: M003
BACTINE MAXBACTINE MAX WOUND WASHWellSpring Pharmaceutical Corporation39b26c28-93e0-41a9-8018-f73525ebc0152025-01-08WarningsExact identifier
application number: M003
sterilePOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0658a0c8-f5ec-b380-e063-6394a90afff52025-01-08WarningsExact identifier
application number: M003
Betadine Surgical ScrubPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1ad39e11-ea1e-44a4-8224-93f8135436c22025-01-06WarningsExact identifier
application number: M003
First Aid AntisepticBENZALKONIUM CHLORIDEWater-Jel Technologies2b3cb958-c0c4-47fd-8338-7c7821135f2b2025-01-06WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLWater-Jel Technologies54e62104-8076-41db-afe5-6dc5c3563acc2025-01-06WarningsExact identifier
application number: M003
Betadine SolutionPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.41891599-420e-48d2-8e31-d28a2209e3832025-01-06WarningsExact identifier
application number: M003
Signature Care Alcohol Prep PadISOPROPYL ALCOHOLBetter Living Brands LLCadc87331-1aa1-3457-e053-2a95a90a7eb12025-01-03WarningsExact identifier
application number: M003
Alcohol Extra-ThickISOPROPYL ALCOHOLMeijer Distribution Inc0b02643d-ea14-4877-ae9c-f0749d1b2d102025-01-03WarningsExact identifier
application number: M003
Premier ValueISOPROPYL ALCOHOLPharmacy Value Alliance, LLCd2baa47e-9673-7f23-e053-2a95a90adcb72025-01-03WarningsExact identifier
application number: M003
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy88f761c1-cb50-4edc-9a54-43444378eff72025-01-03WarningsExact identifier
application number: M003
Sterile AlcoholISOPROPYL ALCOHOLChain Drug Marketing Association Inc55922632-3768-4450-9389-ba7d7d91f2c92025-01-03WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCASAD Company, Inc1e314157-c64e-492a-89ad-2b28831d551d2025-01-03WarningsExact identifier
application number: M003
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.00002127-02bc-4c66-b0c3-ca29d8224afc2025-01-02WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON CANDYALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d02e4d6-8751-b5bc-e063-6394a90a9d972025-01-01WarningsExact identifier
application number: M003
COVISIDE HAND SANITIZERISOPROPYL ALCOHOLCREAGEN INCa9f07fcd-4d5c-362c-e053-2a95a90a2e792024-12-30WarningsExact identifier
application number: M003
KEEPAN ABENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.a30679d5-5507-499d-9d9f-498095fd32ac2024-12-30WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSNf0e637d9-d61e-466d-9e05-f906639dbaca3
581660ethanol 0.62 ML/ML Topical GelSCDf0e637d9-d61e-466d-9e05-f906639dbaca3
581660ethanol 62 % Topical GelSYf0e637d9-d61e-466d-9e05-f906639dbaca3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-014-0157337001401237 mL in 1 BOTTLE (57337-014-01) 237 ml2013-07-050000-00-00NoNoCurrent