Menthol cough drops

Product NDC
50594-038
Requested package NDC
50594-038-80
11-digit product format
505940038
Labeler code
50594
Product ID
50594-038_ec9815be-b6f8-d401-e053-2a95a90a1e2f
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Big Lots
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-11-17
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50594-03850594-038-80DDiscontinued by firm2026-10-05

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
50594-038MENTHOL COUGH DROPS (MENTHOL) LOZENGE [BIG LOTS]6Legacy NDC20240110_5e32b0e7-55ca-2a49-e053-2991aa0a23b4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50594-038-805059400388080 LOZENGE in 1 BAG (50594-038-80) 80 lozenge2017-11-170000-00-00NoNoCurrent