FDA.reportPublic FDA data

Hand sanitizer 8oz with vitamin E

Product NDC
57337-140
11-digit product format
573370140
Labeler code
57337
Product ID
57337-140_568a87bd-a3f2-705a-e063-6294a90a9e44
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol 70%
Dosage form
LIQUID
Route
TOPICAL
Labeler
REJOICE INTERNATIONAL CORP.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-28
Substance
ALCOHOL
Active strength
70 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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57337-140-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57337-140-010efc9e666f02…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
Hand sanitizer 8oz with vitamin E
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 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
582753Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
03f4a507-df3f-e265-e063-6294a90acd11Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-140-01Hand sanitizer 8oz with vitamin E236 mL in 1 BOTTLELIQUID2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-140HAND SANITIZER 8OZ WITH VITAMIN E (ETHYL ALCOHOL 70%) LIQUID [REJOICE INTERNATIONAL CORP.]2Current NDC, 1 package rows20250124_03f4a507-df3f-e265-e063-6294a90acd11.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 87 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand sanitizer 16.9oz with vitamin EETHYL ALCOHOL 70%REJOICE INTERNATIONAL CORP.03f869b3-3004-8b25-e063-6294a90a176e2025-02-06WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percent WintergreenISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)444cd7f4-cf61-49b6-a93e-915d250838da2025-02-06WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON VANILLIAALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d613ab9-c87b-1f3c-e063-6394a90a31202025-02-05WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COCONUTALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d6148e2-d959-6150-e063-6294a90acba52025-02-05WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER WATERMELONALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d6175c9-abe5-4c68-e063-6394a90afc362025-02-05WarningsExact identifier
application number: M003
Hand sanitizer 29ml 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.eb5d6739-ee36-cd74-e053-2a95a90ab6592025-02-05WarningsExact identifier
application number: M003
Hand sanitizer 29ml 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.037b4acb-49ca-bc0a-e063-6394a90a1fcc2025-02-05WarningsExact identifier
application number: M003
BIOPURE 50CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.ecef31dc-2f36-b578-e053-2995a90a3acd2025-02-05WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)444883fc-7ae4-4dd3-bd2b-f94c3265c1702025-02-05WarningsExact identifier
application number: M003
PHARMACIST CHOICE ALCOHOL STERILE PREP PADISOPROPYL ALCOHOLSimple Diagnostics0fc4a4b2-342b-5948-e054-00144ff88e882025-02-04WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd32055326-c229-5f10-e063-6394a90ab62c2025-02-01WarningsExact identifier
application number: M003
Hand Sanitizer Pink SugarALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e5a64-dda1-c24e-e063-6394a90a82982025-02-01WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEJianerkang Medical Co., Ltd3fce67c9-14e9-4e26-bb7f-9375a7f84a8a2025-01-31WarningsExact identifier
application number: M003
AntisepticALCOHOLWelly Health PCB85ce2c23-25d8-4b35-95ff-99f098d92bc92025-01-29WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e13511b-fbb3-2523-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Strawberry ScentedETHYL ALCOHOLNingbo Rejoice Internationala267a7a2-79b9-1da3-e053-2995a90a3a112025-01-28WarningsExact identifier
application number: M003
On Guard Sanitizing GelALCOHOLdoTERRA International, LLCe4b8b4bb-1d47-6826-e053-2a95a90ab1682025-01-28WarningsExact identifier
application number: M003
germstarLuxeETHYL ALCOHOLSoaptronic, LLC471b466f-e3e5-3601-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLGFA Production (Xiamen) Co., Ltd.51348666-53e3-4cc7-99ba-cf3f23ddbcf62025-01-27WarningsExact identifier
application number: M003
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.0fc6a0df-2b1f-4415-8c7a-ee484b1d21fa2025-01-27WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582753ethanol 70 % Topical SolutionPSN03f4a507-df3f-e265-e063-6294a90acd112
582753ethanol 0.7 ML/ML Topical SolutionSCD03f4a507-df3f-e265-e063-6294a90acd112
582753ethanol 70 % Topical SolutionSY03f4a507-df3f-e265-e063-6294a90acd112
582753ethyl alcohol 70 % Topical SolutionSY03f4a507-df3f-e265-e063-6294a90acd112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57337-140-0157337014001236 mL in 1 BOTTLE (57337-140-01) 236 ml2023-08-28NoNoCurrent