FDA.reportPublic FDA data

Ben E.Keith

Product NDC
50980-056
11-digit product format
509800056
Labeler code
50980
Product ID
50980-056_efd88aeb-af47-4ddc-a83b-899f53b423b4
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Ben E. Keith
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-01-02
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
62 mL/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50980-056DDiscontinued by firm2026-10-15
excluded packagepackage50980-05650980-056-19DDiscontinued by firm2026-10-15

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
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50980-056-19fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50980-056-1986f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50980-056-19bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-03-01Drug Facts
2022-01-28Drug Facts
2019-10-31Drug Facts
2019-10-21Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50980-056-19Ben E.KeithHand Cleaner237 mL in 1 BOTTLE, PUMPGEL2376

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EthanolACTIVE INGREDIENT3K9958V90MBEN E.KEITH HAND CLEANER (ETHYL ALCOHOL) GEL [BEN E. KEITH]1
EthanolACTIVE MOIETY3K9958V90MBEN E.KEITH HAND CLEANER (ETHYL ALCOHOL) GEL [BEN E. KEITH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50980-056BEN E.KEITH HAND CLEANER (ETHYL ALCOHOL) GEL [BEN E. KEITH]6Legacy NDC, 1 package rows20250125_042ceb6e-ce5f-4b1f-b947-16829e3e7a43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN042ceb6e-ce5f-4b1f-b947-16829e3e7a436
581660ethanol 0.62 ML/ML Topical GelSCD042ceb6e-ce5f-4b1f-b947-16829e3e7a436
581660ethanol 62 % Topical GelSY042ceb6e-ce5f-4b1f-b947-16829e3e7a436

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50980-056-1950980005619237 mL in 1 BOTTLE, PUMP (50980-056-19) 237 ml2009-01-020000-00-00NoNoCurrent