Home NDC 12546-241 HALLS
Product NDC 12546-241
11-digit product format 125460241
Labeler code 12546
Product ID 12546-241_53d459a4-d29c-9885-e063-6394a90add1d
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 2019-01-25
Substance MENTHOL
Active strength 1.8 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
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 Honey
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 1.8 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 1429019 Internal RxNorm lookup 2109514 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 12546-241-30 HALLSHoney 30 in 1 BAG LOZENGE 30 3 12546-241-40 HALLSHoney 40 in 1 BAG LOZENGE 40 3 12546-241-80 HALLSHoney 80 in 1 BAG LOZENGE 80 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12546-241 HALLS HONEY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC] 3 Current NDC, Legacy NDC, 3 package rows 20240622_837f5ded-8efb-402b-a1bc-b5c142755660.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 12546-241-30 12546024130 30 LOZENGE in 1 BAG (12546-241-30) 30 lozenge 2019-01-25 0000-00-00 No No Current 12546-241-40 12546024140 40 LOZENGE in 1 BAG (12546-241-40) 40 lozenge 2019-01-25 0000-00-00 No No Current 12546-241-80 12546024180 80 LOZENGE in 1 BAG (12546-241-80) 80 lozenge 2019-01-25 0000-00-00 No No Current