Instant Hand Sanitizer

Product NDC
57337-082
11-digit product format
573370082
Labeler code
57337
Product ID
57337-082_2d75cd88-3733-35e3-e063-6394a90a1158
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Rejoice International Corp.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-04-25
Substance
ALCOHOL
Active strength
62 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57337-082-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57337-082-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57337-082-010efc9e666f02…f202fb6c5f17…

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL62 mL/100mL

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
4e042f5b-3f0c-1830-e054-00144ff88e88Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-082-012025-02-06C16284748780-12cef2736-b057-d83d-e063-dadaa90ab31f4e042f5b-3f0c-1830-e054-00144ff88e88
57337-082-012025-01-30C16284748780-12cef2736-b057-d83d-e063-dadaa90ab31f4e042f5b-3f0c-1830-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-082-01Instant Hand Sanitizer53 mL in 1 BOTTLEGEL533

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-082INSTANT HAND SANITIZER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL CORP.]3Current NDC, Legacy NDC, 1 package rows20250209_4e042f5b-3f0c-1830-e054-00144ff88e88.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 106 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XtraCare Antibacterial Hand Cleanse Strawberry PomegranateTRICLOSANRejoice International, Inc.b68a7d64-2650-4fc6-a89e-05de9098a2a32024-02-28WarningsExact identifier
application number: M003
XtraCare Antibacterial Hand Cleanse Mountain SpringTRICLOSANRejoice International, Inc.c31723d5-a313-448a-8b69-ca5f8dec25ed2024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Pink Cherry BlossomBENZALKONIUM CHLORIDERejoice Internationala9a1467c-abcc-4ccb-88f6-4302796097882024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry BlossomBENZALKONIUM CHLORIDERejoice International9fa9d955-7167-4a0a-935b-2a600f439eb02024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion FlowerBENZALKONIUM CHLORIDERejoice International157a14bf-f46e-49f8-96f4-a6c472eb5cb82024-02-28WarningsExact identifier
application number: M003
XtraCare Foaming Hand SanitizerBENZALKONIUM CHLORIDERejoice International3082cbbb-a0ed-45eb-a116-ad1c65357dd12024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Wild Berry BlastBENZALKONIUM CHLORIDERejoice International45b3ca49-edb4-4840-b857-d24045494a3a2024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Vanilla Passion FlowerBENZALKONIUM CHLORIDERejoice International4890f81e-7994-4ea2-9412-5614c405a2a32024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Wild Berry BlastBENZALKONIUM CHLORIDERejoice International5c109f7c-1f4d-484a-b6ea-3bbcf572bbac2024-02-28WarningsExact identifier
application number: M003
XtraCare Hand Sanitizer Moisurize with Vitamin E and AloeETHYL ALCOHOLRejoice International2851ad2a-e108-424c-86d6-c898567695ef2024-02-28WarningsExact identifier
application number: M003
XtraCare Hand Sanitizer Moisturize with Vitamin EETHYL ALCOHOLRejoice International13c99570-0859-4310-843a-5eb266698eb32024-02-28WarningsExact identifier
application number: M003
XtraCare Instant Hand SanitizerETHYL ALCOHOLRejoice Internationala339dfd9-7cb8-4198-bc2a-9759648cf34e2024-02-28WarningsExact identifier
application number: M003
XtraCare Instant Hand SanitizerETHYL ALCOHOLRejoice Internationalf15a90e2-4a1e-452a-b9ac-5eb6f7b3dc722024-02-28WarningsExact identifier
application number: M003
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZERETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd11ef87cc-6ff6-511b-e063-6294a90a662f2024-02-21WarningsExact identifier
application number: M003
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZERETHYL ALCOHOLMY IMPORTS USA LLC11f19126-6abb-b14c-e063-6294a90a4e342024-02-21WarningsExact identifier
application number: M003
AntisepticANTISEPTIC SPRAYDynarex Corporation118192ac-7173-09c5-e063-6394a90ad5502024-02-16WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOL SPRAYDynarex Corporation116e0c9c-cbe0-bf67-e063-6394a90ae5302024-02-15WarningsExact identifier
application number: M003
POVIDONE-IODINEPOVIDONE-IODINEHART Health92b6a38e-c7bb-45e2-9c2a-7993ed1bac362024-02-15WarningsExact identifier
application number: M003
Povidone Iodine Gel SwabstickPOVIDONE IODINE GEL SWABSTICKDynarex Corporationeb7e21be-521e-2d52-e053-2a95a90ade332024-02-13WarningsExact identifier
application number: M003
AntisepticALCOHOL, LIDOCAINE HYDROCHLORIDESafetec of America, Inc.71aeaf86-2b4d-4945-9606-a9db0ab6b7262024-02-07WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN4e042f5b-3f0c-1830-e054-00144ff88e883
581660ethanol 0.62 ML/ML Topical GelSCD4e042f5b-3f0c-1830-e054-00144ff88e883
581660ethanol 62 % Topical GelSY4e042f5b-3f0c-1830-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-082-015733700820153 mL in 1 BOTTLE (57337-082-01) 53 ml2017-04-250000-00-00NoNoCurrent