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
2026-12-31
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
2026-12-31

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 5 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hand sanitizer- light pink 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598c41f0-908d-df52-e063-6394a90a3c8d2026-08-21WarningsExact identifier
application number: M003
Olimpo AntibacterialBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.597e3b3e-51f0-5fcf-e063-6394a90ac2972026-08-20WarningsExact identifier
application number: M003
Benzalkonium ChlorideBENZALKONIUM CHLORIDE TOWELETTESTrifecta Pharmaceuticals USA LLC59811e67-57f0-4db1-e063-6294a90a2ad82026-08-20WarningsExact identifier
application number: M003
inControl alcoholISOPROPYL ALCOHOLH-E-B45dfbd7a-0ae1-4146-9527-5483c884e6362026-08-18WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEThe Kroger Co.52f6258f-4b4c-49f4-9bc7-40dc3918869d2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLThe Kroger Co.b127bba1-ce0b-4142-8b7d-f12f062b09382026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLThe Kroger Co.cd3f8779-9e57-4b23-a029-7424d4d4ab2a2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLThe Kroger Co.ca6c7f8a-d41a-4d77-817c-3dbdc40f890e2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
Alcohol Sanitizer Spray.ETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fb9efe-43f0-1b7f-e063-6394a90a01452026-08-14WarningsExact identifier
application number: M003
Povidone-IodinePOVIDONE-IODINEMajor Pharmaceuticals59041ca3-a195-5a20-e063-6394a90a2ac92026-08-14WarningsExact identifier
application number: M003
Alcohol Hand SanitizerETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fa90dc-c3b5-787b-e063-6294a90a2e172026-08-13WarningsExact identifier
application number: M003
SprinJeneALCOHOLHealth and Natural Beauty USA Corp1853f023-f4db-4cd8-a4df-a439bc306cc32026-08-13WarningsExact identifier
application number: M003
LUXURY IPA 70%LUXURY ISOPROPYL ALCOHOL 70% 16OZTSM BRANDS LLC2240a9e0-dac5-54fa-e063-6394a90a35f52026-08-11WarningsExact identifier
application number: M003
Ethyl alcoholETHYL ALCOHOLStrategic Sourcing Services LLC4fec6f1f-0249-423f-bd3c-427aa6924c6f2026-08-10Warnings, Adverse reactionsExact identifier
application number: M003
antibacterial hand wipes (JUICY WATERMELON)ANTIBACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.5883c43d-212b-af39-e063-6394a90ad6522026-08-08WarningsExact identifier
application number: M003
LIGHTS Antiseptic and Pain Relieving Prep PadISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.91cc7334-f610-487d-a895-3dda78c3372e2026-08-07WarningsExact identifier
application number: M003
CVS Beauty Hydrating Hand Sanitizer SANDALWOOD MUSKETHYL ALCOHOLCVS Pharmacy, Inc.60128fc3-b127-44ee-9e9b-384d322d213a2026-08-07WarningsExact identifier
application number: M003
CVS Beauty Hydrating Hand Sanitizer Sea Salt and LavenderETHYL ALCOHOLCVS Pharmacy, Inc.6c160826-ad98-4390-a07b-c92a2ae5b1812026-08-07WarningsExact identifier
application number: M003
antibacterial hand wipes (2257C)ANTIBACTERIAL HAND WIPES (2257C)Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.585a1c36-7bdc-4d4f-e063-6394a90ad6d22026-08-06WarningsExact identifier
application number: M003
antibacterial hand wipes (Angel)ANTIBACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.585c4a14-8dc9-3a08-e063-6394a90ab4f52026-08-06WarningsExact 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