FDA.reportPublic FDA data

Honey Lemon cough drops

Product NDC
55910-053
Requested package NDC
55910-053-30
11-digit product format
559100053
Labeler code
55910
Product ID
55910-053_ece8421c-f6ac-50a5-e053-2a95a90a8bcc
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
2016-07-22
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
8 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 packagepackage55910-05355910-053-30DDiscontinued 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
55910-053-802020-01-31C16284748780-19d75b9d0-428b-f424-e053-dadaa90a57ceMenthol 7.5 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-053-80Honey Lemon Cough Drops80 in 1 BAGLOZENGE802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-053HONEY LEMON COUGH DROPS (MENTHOL) LOZENGE [DOLLAR GENERAL CORPORATION]8Legacy NDC20241203_323011c1-cb14-42ea-e054-00144ff8d46c.zip
55910-053HONEY LEMON COUGH DROPS (MENTHOL) LOZENGE [DOLLAR GENERAL CORPORATION]8Legacy NDC20241203_3d1f22c7-54bc-01bd-e054-00144ff8d46c.zip
55910-053HONEY LEMON COUGH DROPS (MENTHOL) LOZENGE [DOLLAR GENERAL CORPORATION]2Legacy NDC, 1 package rows20171108_32307aff-40c1-686c-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250189menthol 7.5 MG Oral LozengePSN32307aff-40c1-686c-e054-00144ff8d46c2
1250189menthol 7.5 MG Oral LozengeSCD32307aff-40c1-686c-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-053-305591000533030 LOZENGE in 1 BAG (55910-053-30) 30 lozenge2016-03-220000-00-00NoNoCurrent