FDA.reportPublic FDA data

b.clean hand sanitizer

Product NDC
73978-001
11-digit product format
739780001
Labeler code
73978
Product ID
73978-001_a217f7ae-f38f-841c-e053-2995a90acea1
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Marque of Brands Americas, LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
60 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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct73978-001DDiscontinued by firm2026-10-12
excluded packagepackage73978-00173978-001-01DDiscontinued by firm2026-10-12
excluded packagepackage73978-00173978-001-02DDiscontinued by firm2026-10-12
excluded packagepackage73978-00173978-001-03DDiscontinued by firm2026-10-12
excluded packagepackage73978-00173978-001-04DDiscontinued by firm2026-10-12

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 · 5 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage73978-001-04
excluded packagepackage73978-001-02
excluded packagepackage73978-001-03
excluded packagepackage73978-001-01

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73978-001B.CLEAN HAND SANITIZER (ALCOHOL) GEL [MARQUE OF BRANDS AMERICAS, LLC]2Legacy NDC20240703_a217faa1-0edb-63c0-e053-2995a90a0284.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73978-001-017397800010159 mL in 1 BOTTLE, PLASTIC (73978-001-01) 59 ml2020-03-300000-00-00NoNoCurrent
73978-001-0273978000102236 mL in 1 BOTTLE, PUMP (73978-001-02) 236 ml2020-03-300000-00-00NoNoCurrent
73978-001-0373978000103473 mL in 1 BOTTLE, PUMP (73978-001-03) 473 ml2020-03-300000-00-00NoNoCurrent
73978-001-0473978000104946 mL in 1 BOTTLE, PUMP (73978-001-04) 946 ml2020-03-300000-00-00NoNoCurrent