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 39 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand sanitizerHAND SANITIZER SPRAYBeimei Biotechnology (Guangzhou) Co., Ltd.49455156-1072-14f5-e063-6294a90abdff2026-01-26WarningsExact identifier
application number: M003
Anti-bacterial Hand WipesANTI-BACTERIAL HAND WIPESJinhua Aidi Daily Chemical Co., Ltd.494b09a4-4982-13bf-e063-6394a90a486f2026-01-26WarningsExact identifier
application number: M003
Homworks Alcohol Wipes MultipurposeETHYL ALCOHOLAcadian Crossing Consumer Products, LLC.c9f0c3b3-5f39-dfa6-e053-2995a90a76442026-01-26WarningsExact identifier
application number: M003
BZK PadsBENZALKONIUM CHLORIDEDynarex Corporation87288939-cc34-4437-94ab-dcb997d6acd52026-01-23WarningsExact identifier
application number: M003
BZK PadsBENZALKONIUM CHLORIDEDynarex Corporation10454042-ff2e-44ce-b2e2-436cc004897f2026-01-23WarningsExact identifier
application number: M003
Everlit Survival Sting Relief PadISOPROPYL ALCOHOLEVERLIT GLOBAL INC.3a0414ea-f862-aa0f-e063-6294a90aecb72026-01-23WarningsExact identifier
application number: M003
MedlinePOVIDONE-IODINEMedline Industries, LP48ebfdd6-d346-7e26-e063-6394a90af11a2026-01-23WarningsExact identifier
application number: M003
EVERLIT SURVIVAL IODINE PREP PADSPOVIDONE-IODINEEVERLIT GLOBAL INC.3a03fc8d-2653-9183-e063-6294a90ad76e2026-01-23WarningsExact identifier
application number: M003
EVERLIT SURVIVAL PREP PADISOPROPYL ALCOHOLEVERLIT GLOBAL INC.3a03ed81-5b1d-172e-e063-6394a90ac59c2026-01-23WarningsExact identifier
application number: M003
Everlit Survival Antiseptic WipeANTISEPTIC WIPEEVERLIT GLOBAL INC.3a03f7e6-cc74-22a2-e063-6394a90a5f9f2026-01-23WarningsExact identifier
application number: M003
Rite Aid Isopropyl Alcohol WipesISOPROPYL ALCOHOLRite Aidbca837b0-5044-4e97-e053-2a95a90a13af2026-01-22WarningsExact identifier
application number: M003
Drs. Pharmacy Triple Antibiotic AND BURN RELIEFBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOL PHARMA TECH, LLC Drs PHARMACY4928d9dd-542b-fe8b-e063-6294a90a92522026-01-22WarningsExact identifier
application number: M003
DOP Ethyl Alcohol 70%ETHYL ALCOHOLOmega & Delta Co., Inc.b96d85f8-739c-4b96-9dd5-8119ebf66c9f2026-01-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Rose LycheeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48dfcbe1-8e0c-1715-e063-6394a90a733f2026-01-21WarningsExact identifier
application number: M003
Lights Povindone Iodine SwabstickPOVIDONE-IODINELights Medical Manufacture Co., Ltd.977b6077-bf47-4e02-bde4-c752e73d76282026-01-21WarningsExact identifier
application number: M003
Lights Povindone Iodine ScrubPOVIDONE-IODINELights Medical Manufacture Co., Ltd.000bf57b-1805-4746-bf1c-32856241213a2026-01-21WarningsExact identifier
application number: M003
Lights Povidone Iodine SolutionPOVIDONE-IODINELights Medical Manufacture Co., Ltd.6946eb98-6870-4b21-9dda-b01a8adab84b2026-01-21WarningsExact identifier
application number: M003
Lights Povidone Iodine Prep PadPOVIDONE-IODINELights Medical Manufacture Co., Ltd.e561332d-e419-43db-a68e-0c0d49b01c9a2026-01-21WarningsExact identifier
application number: M003
Lights Povindone Iodine SwabstickPOVIDONE-IODINELights Medical Manufacture Co., Ltd.2610fde4-4572-4d15-a970-f6d3beb734fe2026-01-21WarningsExact identifier
application number: M003
Lights Povidone Iodine SolutionPOVIDONE-IODINELights Medical Manufacture Co., Ltd.7d4a92be-0601-4256-bc5b-bc1b07d97bb72026-01-21WarningsExact 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