FDA.reportPublic FDA data

Instant Hand Sanitizer - Original

Product NDC
57337-017
11-digit product format
573370017
Labeler code
57337
Product ID
57337-017_126c34cd-7a3c-af36-e063-6294a90ab5f3
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
33 mL/53mL
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 - Original
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL33 mL/53mL

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
bb9cc886-275e-4996-99dc-529f928b4905Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-017-022024-02-28C16284748780-11030e365-0289-111a-e063-dadaa90a10e2Instant Hand Sanitizer - Original
57337-017-022024-01-30C16284748780-11030e365-0289-111a-e063-dadaa90a10e2Instant Hand Sanitizer - Original

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-017-01Instant Hand Sanitizer - Original53 mL in 1 BOTTLEGEL533
57337-017-02Instant Hand Sanitizer - Original2 in 1 PACKAGEGEL23

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-017INSTANT HAND SANITIZER - ORIGINAL (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]3Current NDC, Legacy NDC, 2 package rows20240229_bb9cc886-275e-4996-99dc-529f928b4905.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 43 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Surgical Scrub Brush/Sponge With Nail CleanerPOVIDONE IODINEXinxiang Xinda Technology Co.,Ltd12585502-c043-6ffb-e063-6394a90a66022026-01-08WarningsExact identifier
application number: M003
Thompson AlcoholISOPROPYL ALCOHOLThompsonf539db3b-f309-6a60-e053-2a95a90a5a9b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d35899-8b70-14f0-e053-2995a90a5ce82026-01-08WarningsExact identifier
application number: M003
Germ AwayANTI-MICROBIAL WIPEUnico International Trading Corpa6b4eec4-0b12-3a00-e053-2a95a90a78352026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d0ce42-9076-143c-e053-2995a90aeeb62026-01-08WarningsExact identifier
application number: M003
WipexANTIBACTERIAL WIPEUnico International Trading Corporation261c7b8f-4adc-72ec-e063-6394a90a92112026-01-08WarningsExact identifier
application number: M003
WipexANTIBACTERIAL WIPEUnico International Trading Corporation144453a2-8335-77be-e063-6394a90ab6762026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d40204-3f69-7fb7-e053-2995a90a278b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTIBACTERIAL HAND WIPEUnico International Trading Corpad7d8546-d440-e661-e053-2a95a90a8fd32026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d47c07-12bd-3c8f-e053-2a95a90a95642026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d7f260-f5be-7940-e053-2995a90aaa032026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTIBACTERIALUnico International Trading Corpada02f20-07ef-9e90-e053-2995a90a0e8b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-BACTERIALUnico International Trading Corpadb59182-6541-2b35-e053-2a95a90a0f712026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Companya10f18e0-b47c-424b-847e-bcc25aa250a42026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Company5b8cff3c-71d2-418f-a43d-f570aa5408fd2026-01-08WarningsExact identifier
application number: M003
Fortinia IDPHENOLThe Podiatree Company60c88eb7-22fe-4881-e053-2a91aa0a70ce2026-01-08WarningsExact identifier
application number: M003
Gentian Violet 2%GENTIAN VIOLET 2%The Podiatree Company60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b82026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNDC, Inc.07bfadf4-7452-4c7a-b60e-feb658b92e732026-01-08WarningsExact identifier
application number: M003
Hydrogen Peroxide 3%HYDROGEN PEROXIDE 3%Epic Medical Supply Corp.0da45476-46c3-428c-a2d9-70865d2b12772026-01-08WarningsExact identifier
application number: M003
Roll On Anti Perspirant Alcohol FreeALUMINUM CHLOROHYDRATEMedline Industries, LP4f706801-dc2d-48c4-aa06-92207d86e55e2026-01-08WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSNbb9cc886-275e-4996-99dc-529f928b49053
581660ethanol 0.62 ML/ML Topical GelSCDbb9cc886-275e-4996-99dc-529f928b49053
581660ethanol 62 % Topical GelSYbb9cc886-275e-4996-99dc-529f928b49053

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-017-015733700170153 mL in 1 BOTTLE53 mlHistorical
57337-017-02573370017022 BOTTLE in 1 PACKAGE (57337-017-02) / 53 mL in 1 BOTTLE (57337-017-01) 2 bottle2013-07-050000-00-00NoNoCurrent