Home NDC 76162-014 Cough Drops
Product NDC 76162-014
11-digit product format 761620014
Labeler code 76162
Product ID 76162-014_23e6ffd4-e4d1-3cb8-e063-6394a90a1761
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 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 Ingredient Strength MENTHOL 5.8 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 476973 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76162-014-01 Cough Drops 30 in 1 BAG PASTILLE 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76162-014 COUGH DROPS (MENTHOL) PASTILLE [TOPCO ASSOCIATES LLC] 2 Current NDC, Legacy NDC, 1 package rows 20241010_eff16ba3-7e30-aa93-e053-2995a90a64cb.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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76162-014-01 76162001401 30 PASTILLE in 1 BAG (76162-014-01) 30 pastille 2022-12-14 0000-00-00 No No Current