Cough Drops

Product NDC
59450-716
11-digit product format
594500716
Labeler code
59450
Product ID
59450-716_2db9eeef-5d9f-dc28-e063-6294a90ae099
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PASTILLE
Route
ORAL
Labeler
The Kroger CO
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-13
Substance
MENTHOL
Active strength
7.5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Cough Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1250189Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f6da2e02-42c7-1ede-e053-6394a90aff5fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59450-716-01Cough Drops80 in 1 BAGPASTILLE803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59450-716COUGH DROPS (MENTHOL) PASTILLE [THE KROGER CO]3Current NDC, 1 package rows20250212_f6da2e02-42c7-1ede-e053-6394a90aff5f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 98 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Drops Dollar General Severe Honey Lemon 45ctMENTHOLDollar General Corporation0ea61a4c-690a-4349-9952-cc17fb1f06712025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 30ctMENTHOLDollar General Corporation892092cc-5a1c-4309-baf9-a040888d35772025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 80ctMENTHOLDollar General Corporation773f4ad2-6c91-431f-ad3d-c0e53e7ca9182025-10-08WarningsExact identifier
application number: M012
Menthol Drops Dollar General Severe 45ctMENTHOLDollar General Corporation13c7d3b1-12ac-4931-877c-728d3d89942c2025-10-08WarningsExact identifier
application number: M012
Menthol Drops Dollar General Severe Honey Lemon 45ctMENTHOLDollar General Corporationd0c878f0-a737-4583-9847-834af70e7d6f2025-10-08WarningsExact identifier
application number: M012
Cough Drops Freegells Strawberry 30ctMENTHOLR.L. ALBERT & SON, INCdc077c36-c403-4b83-894a-e9922e9288412025-10-08WarningsExact identifier
application number: M012
Cough Drops Freegells Strawberry 30ctMENTHOLRL Albert & Son Inc.2ea760f3-df50-4c46-a43d-d5ed07f421a52025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Honey Lemon 200ctMENTHOLRL Albert & Son Inc.3ac08274-08d9-4dab-b09a-6e297948a25a2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Honey Lemon 30ctMENTHOLRL Albert & Son Inc.8114e1a2-728d-4489-a494-f28a5e7d9bb32025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol 30ctMENTHOLRL Albert & Son Inc.0c2e594a-cdf8-4595-bda6-0ebc19ac38502025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 200ctMENTHOLR.L. ALBERT & SON, INCf62b7f75-3275-46c9-880c-64148d0dce592025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol 80ctMENTHOLR.L. ALBERT & SON, INC15917bfb-f660-4a12-bdcc-5b4a96e0e1d02025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 30ctMENTHOLRL Albert & Son Inc.92c54c53-c8bb-4576-abae-715a2f3878bf2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol 80ctMENTHOLRL Albert & Son Inc.c96cc162-5908-4990-9dc1-3ce9128442742025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 30ctMENTHOLR.L. ALBERT & SON, INCbac77712-6197-4b30-a5f8-9b99eb9d7b5a2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 80ctMENTHOLR.L. ALBERT & SON, INC6842d766-ade6-40b2-831b-f4feac25c6db2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 80ctMENTHOLRL Albert & Son Inc.9f324ca1-0e2a-47e3-997e-2aaa68a857512025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey Lemon 30ctMENTHOLR.L. ALBERT & SON, INC2063a013-aa0b-465d-b04f-cfe2e70d749f2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey Lemon 200ctMENTHOLR.L. ALBERT & SON, INCcd81488c-74d8-48d9-9c73-ff662a5cd4cd2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey Lemon 80ctMENTHOLR.L. ALBERT & SON, INC61deea94-d0a9-4563-926b-53f255a7c4252025-10-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250189menthol 7.5 MG Oral LozengePSNf6da2e02-42c7-1ede-e053-6394a90aff5f3
1250189menthol 7.5 MG Oral LozengeSCDf6da2e02-42c7-1ede-e053-6394a90aff5f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59450-716-015945007160180 PASTILLE in 1 BAG (59450-716-01) 80 pastille2023-03-14NoNoCurrent