FDA.reportPublic FDA data

Sugar Free Menthol Cough Drops

Product NDC
55910-059
Requested package NDC
55910-059-70
11-digit product format
559100059
Labeler code
55910
Product ID
55910-059_ece8ac9c-3bf8-e6ec-e053-2995a90a56b1
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Dollar General Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-03-22
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
6 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 packagepackage55910-05955910-059-70DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-059-302020-01-31C16284748780-19d75b9d1-1de5-f424-e053-dadaa90a57ceMenthol 5.8 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-059-30Sugar Free Menthol Cough Drops30 in 1 BAGLOZENGE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-059SUGAR FREE MENTHOL COUGH DROPS (MENTHOL) LOZENGE [DOLLAR GENERAL CORPORATION]8Legacy NDC20241203_35def423-1acc-48e6-e054-00144ff88e88.zip
55910-059SUGAR FREE MENTHOL COUGH DROPS (MENTHOL) LOZENGE [DOLLAR GENERAL CORPORATION]2Legacy NDC, 1 package rows20171108_326f79f9-26be-66e5-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476973menthol 5.8 MG Oral LozengePSN326f79f9-26be-66e5-e054-00144ff88e882
476973menthol 5.8 MG Oral LozengeSCD326f79f9-26be-66e5-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-059-705591000597070 LOZENGE in 1 BAG (55910-059-70) 70 lozenge2016-03-220000-00-00NoNoCurrent