Home NDC 68016-885 Premier Value
Product NDC 68016-885
11-digit product format 680160885
Labeler code 68016
Product ID 68016-885_468e78a5-7a98-6efb-e063-6394a90aba2b
Type HUMAN OTC DRUG
Nonproprietary name Cough Drops Menthol
Dosage form LOZENGE
Route ORAL
Labeler Pharmacy Value Alliance LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-31
Substance MENTHOL
Active strength 5.4 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 Premier Value
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 5.4 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 485287 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68016-885-30 Premier Value 5.4 in 1 BAG LOZENGE 5.4 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-885 PREMIER VALUE (COUGH DROPS MENTHOL) LOZENGE [PHARMACY VALUE ALLIANCE LLC] 2 Current NDC, 1 package rows 20241228_019211bf-dd4b-5f4c-e063-6294a90aacfb.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 68016-885-30 68016088530 5.4 LOZENGE in 1 BAG (68016-885-30) 5.4 lozenge 2023-07-31 No No Current