Home NDC 83455-201 Cough Drops
Product NDC 83455-201
11-digit product format 834550201
Labeler code 83455
Product ID 83455-201_23f96ca4-4913-cab8-e063-6394a90a9ec6
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form PASTILLE
Route ORAL
Labeler United Natural Foods, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-12
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 83455-201-01 Cough Drops 200 in 1 BAG PASTILLE 200 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83455-201 COUGH DROPS (MENTHOL) PASTILLE [UNITED NATURAL FOODS, INC.] 2 Current NDC, 1 package rows 20241010_f9f0d020-e031-245e-e053-6294a90addb5.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 Sample Exclude flag Status 83455-201-01 83455020101 200 PASTILLE in 1 BAG (83455-201-01) 200 pastille 2023-05-12 No No Current