FDA.reportPublic FDA data

Menthol Cough Drops

Product NDC
59779-653
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59779-653DDiscontinued by firm2026-10-12
excluded productproduct59779-653DDiscontinued by firm2026-10-12
excluded productproduct59779-653IInactivated by FDA2026-10-12
excluded packagepackage59779-65359779-653-30DDiscontinued by firm2026-10-12
excluded packagepackage59779-65359779-653-00DDiscontinued by firm2026-10-12
excluded packagepackage59779-65359779-653-40IInactivated by FDA2026-10-12

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 2 of 2 · 78 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59779-653-40IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59779-653-30DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59779-653-40IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59779-653-30DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage59779-653-40IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage59779-653-40IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage59779-653-40IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage59779-653-40IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59779-653-40IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59779-653-40IInactivated by FDAbd6a592717d7…303034d00443…

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
59779-653-305977906533030 LOZENGE in 1 BAG (59779-653-30) 30 lozenge2015-05-180000-00-00NoNoCurrent
59779-653-405977906534040 LOZENGE in 1 BAG (59779-653-40) 40 lozenge2015-05-180000-00-00NoNoCurrent