FDA.reportPublic FDA data

Menthol Cough Drops

Product NDC
59779-653
Requested package NDC
59779-653-00
11-digit product format
597790653
Labeler code
59779
Product ID
59779-653_ece3dbf9-2a8c-15b3-e053-2a95a90ac03f
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
CVS Pharmacy
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-05-18
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 packagepackage59779-65359779-653-00DDiscontinued 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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
59779-653-002025-12-07C16284748780-12cef2736-5cfe-d83d-e063-dadaa90ab31fMenthol 5.4 mg
59779-653-002025-01-30C16284748780-12cef2736-5cfe-d83d-e063-dadaa90ab31fMenthol 5.4 mg
59779-653-402022-01-28C16284748780-1d6a99b39-36a4-a426-e053-dadaa90af4c2Menthol 5.4 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-653-40menthol cough drops40 in 1 BAGLOZENGE402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-653MENTHOL COUGH DROPS (MENTHOL) LOZENGE [CVS PHARMACY]6Legacy NDC20231021_3ae87ace-176c-54b7-e054-00144ff8d46c.zip
59779-653MENTHOL COUGH DROPS (MENTHOL) LOZENGE [CVS PHARMACY]2Legacy NDC, 1 package rows20191210_3ae6e278-ef29-6f28-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485287menthol 5.4 MG Oral LozengePSN3ae6e278-ef29-6f28-e054-00144ff88e882
485287menthol 5.4 MG Oral LozengeSCD3ae6e278-ef29-6f28-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-653-0059779065300200 LOZENGE in 1 BAG (59779-653-00) 200 lozenge2015-05-180000-00-00NoNoCurrent