Home NDC 12546-104 Halls
Product NDC 12546-104
11-digit product format 125460104
Labeler code 12546
Product ID 12546-104_307a57f2-a64a-23f5-e063-6394a90a39fc
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form LOZENGE
Route ORAL
Labeler Mondelez Global LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-06-10
Substance MENTHOL
Active strength 5.8 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Halls
Brand name suffix Sugar Free Black Cherry
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 476973 Internal RxNorm lookup 896994 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 12546-104-25 HallsSugar Free Black Cherry 25 in 1 BAG LOZENGE 25 9 12546-104-30 HallsSugar Free Black Cherry 30 in 1 BAG LOZENGE 30 9 12546-104-70 HallsSugar Free Black Cherry 70 in 1 BAG LOZENGE 70 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12546-104 HALLS SUGAR FREE BLACK CHERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC] 9 Current NDC, Legacy NDC, 3 package rows 20250319_bd2a311a-bf0c-4365-af9b-76675c243b22.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 73 of 178 · 3,551 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 12546-104-25 12546010425 25 LOZENGE in 1 BAG (12546-104-25) 25 lozenge 2019-06-10 0000-00-00 No No Current 12546-104-30 12546010430 30 LOZENGE in 1 BAG (12546-104-30) 30 lozenge 2019-06-10 0000-00-00 No No Current 12546-104-70 12546010470 70 LOZENGE in 1 BAG (12546-104-70) 70 lozenge 2019-06-10 0000-00-00 No No Current