Home NDC 12546-338 Halls
Product NDC 12546-338
11-digit product format 125460338
Labeler code 12546
Product ID 12546-338_29b4cc2f-3b75-6ea0-e063-6394a90a0504
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 2019-03-05
Substance MENTHOL
Active strength 2.5 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 Halls
Brand name suffix Honey Vanilla
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 2.5 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 616344 Internal RxNorm lookup 896992 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 12546-338-30 HallsHoney Vanilla 30 in 1 BAG LOZENGE 30 10 12546-338-80 HallsHoney Vanilla 80 in 1 BAG LOZENGE 80 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12546-338 HALLS HONEY VANILLA (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC] 10 Current NDC, Legacy NDC, 2 package rows 20241222_8e94a1b8-8915-4595-b097-8a0a319d54aa.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 12546-338-30 12546033830 30 LOZENGE in 1 BAG (12546-338-30) 30 lozenge 2019-03-05 0000-00-00 No No Current 12546-338-80 12546033880 80 LOZENGE in 1 BAG (12546-338-80) 80 lozenge 2023-03-01 No No Current