Cough Drops

Product NDC
76162-016
11-digit product format
761620016
Labeler code
76162
Product ID
76162-016_23e6fb6c-0b9d-3900-e063-6394a90a5fe6
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PASTILLE
Route
ORAL
Labeler
Topco Associates LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-14
Substance
MENTHOL
Active strength
5.8 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5.8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui476973

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-016-01Cough Drops80 in 1 BAGPASTILLE802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-016COUGH DROPS (MENTHOL) PASTILLE [TOPCO ASSOCIATES LLC]2Current NDC, Legacy NDC, 1 package rows20241010_eff1a70f-fa71-52b2-e053-2995a90a038c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476973menthol 5.8 MG Oral LozengePSNeff1a70f-fa71-52b2-e053-2995a90a038c2
476973menthol 5.8 MG Oral LozengeSCDeff1a70f-fa71-52b2-e053-2995a90a038c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76162-016-017616200160180 PASTILLE in 1 BAG (76162-016-01) 80 pastille2022-12-140000-00-00NoNoCurrent