Home NDC 12546-116 HALLS
Product NDC 12546-116
11-digit product format 125460116
Labeler code 12546
Product ID 12546-116_5127b597-5fb2-628c-e063-6394a90aa962
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 2025-09-01
Substance MENTHOL
Active strength 5.4 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
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 Mentholyptus
Listing expiration 2027-12-31 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 12546-116-30 HALLSMentholyptus 30 in 1 BAG LOZENGE 30 4 12546-116-80 HALLSMentholyptus 80 in 1 BAG LOZENGE 80 4 12546-116-99 HALLSMentholyptus 200 in 1 BAG LOZENGE 200 4
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 Sample Exclude flag Status 12546-116-30 12546011630 30 LOZENGE in 1 BAG (12546-116-30) 30 lozenge 2025-09-01 No No Current 12546-116-80 12546011680 80 LOZENGE in 1 BAG (12546-116-80) 80 lozenge 2025-09-01 No No Current 12546-116-99 12546011699 200 LOZENGE in 1 BAG (12546-116-99) 200 lozenge 2025-09-01 No No Current