Home NDC 12546-109 Halls
Product NDC 12546-109
11-digit product format 125460109
Labeler code 12546
Product ID 12546-109_37b2eaa4-fe74-b6c0-e063-6394a90a5321
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 2019-03-31
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 2 · 108 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 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# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12546-109 HALLS CHERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC] 17 Current NDC, Legacy NDC, 16 package rows 20240517_5f4af8e8-8550-45c7-a199-694efac9e7be.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 68 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Equate SF Menthol Cough Drops MENTHOL WalMart 003a229c-b014-e9f3-e063-6294a90aa5ed 2025-12-23 Warnings Exact identifier application number: M012 Equate Menthol Cough Drops MENTHOL Walmart 124e6968-f59c-39d4-e063-6294a90a66d4 2025-12-23 Warnings Exact identifier application number: M012 Equate Severe Menthol Throat Drop MENTHOL Walmart 125f3f5a-52aa-e398-e063-6394a90a0012 2025-12-23 Warnings Exact identifier application number: M012 Equate Menthol Chewable Gels MENTHOL Walmart 1ba4b2be-7242-0a23-e063-6294a90af29c 2025-12-23 Warnings Exact identifier application number: M012 Walgreens Severe Menthol Throat Drops MENTHOL Walgreens 21dd3c68-cbc6-4799-e063-6394a90a6972 2025-12-23 Warnings Exact identifier application number: M012 cherry throat relief lozenges BENZOCAINE Zee Medical 499d0748-538f-678c-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 Guaiasorb DM DEXTROMETHORPHAN HBR, GUAIFENESIN NuCare Pharmaceuticals, Inc. 46a480c7-7092-b809-e063-6294a90a60cd 2025-12-23 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Winco Foods 360a6304-206d-5475-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Winco Foods 36342d8c-34ab-6178-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Winco Foods 37244333-1307-5121-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Winco foods 37718c73-880e-4a5c-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Winco Foods 40676ddc-577f-5cc9-e054-00144ff88e88 2025-12-23 Warnings Exact identifier application number: M012 Sugar Free Menthol Cough Drops MENTHOL Winco Foods 3788e8b6-ab9e-1513-e054-00144ff88e88 2025-12-23 Warnings Exact identifier application number: M012 SAFETUSSIN Non Drowsy Cough plus chest congestion DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN KRAMER LABORATORIES eeca6370-29ea-4540-8139-e8461d58a286 2025-12-23 Warnings Exact identifier application number: M012 Tussin DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Discount Drug Mart dd31f86b-f59e-459a-8e5f-176828706a4a 2025-12-23 Warnings Exact identifier application number: M012 Tussin CF DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE Discount Drug Mart f8e7a08e-7422-4a1b-bfec-93e0b50d10cd 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ab45ae97-7951-4058-e053-2995a90a7b2e 2025-12-23 Warnings Exact identifier application number: M012 Childrens Chest Congestion Relief Grape GUAIFENESIN Discount Drug Mart 3e5d245f-515c-4106-a855-fb97681b646a 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ab45ed16-86bb-3faf-e053-2995a90acfbc 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC a7999da7-148a-4c6d-a2ea-0f4cc1d5b283 2025-12-23 Warnings Exact identifier application number: M012
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 12546-109-00 12546010900 140 LOZENGE in 1 BAG (12546-109-00) 140 lozenge 2023-04-10 No No Current 12546-109-01 12546010901 100000 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-109-01) 100000 lozenge 2019-12-02 0000-00-00 No No Current 12546-109-02 12546010902 150000 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-109-02) 150000 lozenge 2019-12-02 0000-00-00 No No Current 12546-109-03 12546010903 2400 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-109-03) 2400 lozenge 2019-12-02 0000-00-00 No No Current 12546-109-04 12546010904 720 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-109-04) 720 lozenge 2019-12-02 0000-00-00 No No Current 12546-109-14 12546010914 14 LOZENGE in 1 BAG (12546-109-14) 14 lozenge 2019-03-31 0000-00-00 No No Current 12546-109-16 12546010916 16 LOZENGE in 1 BAG (12546-109-16) 16 lozenge 2019-03-31 0000-00-00 No No Current 12546-109-18 12546010918 18 LOZENGE in 1 BAG (12546-109-18) 18 lozenge 2019-03-31 0000-00-00 No No Current 12546-109-24 12546010924 24 LOZENGE in 1 BAG (12546-109-24) 24 lozenge 2019-12-02 0000-00-00 No No Current 12546-109-30 12546010930 30 LOZENGE in 1 BAG (12546-109-30) 30 lozenge 2019-03-31 0000-00-00 No No Current 12546-109-40 12546010940 40 LOZENGE in 1 BAG (12546-109-40) 40 lozenge 2019-03-31 0000-00-00 No No Current 12546-109-80 12546010980 80 LOZENGE in 1 BAG (12546-109-80) 80 lozenge 2019-03-31 0000-00-00 No No Current 12546-109-89 12546010989 200 LOZENGE in 1 BAG (12546-109-89) 200 lozenge 2019-03-31 0000-00-00 No No Current 12546-109-90 12546010990 250 LOZENGE in 1 JAR (12546-109-90) 250 lozenge 2024-05-20 No No Current 12546-109-96 12546010996 96 LOZENGE in 1 BAG (12546-109-96) 96 lozenge 2019-03-31 0000-00-00 No No Current 12546-109-99 12546010999 160 LOZENGE in 1 PACKAGE (12546-109-99) 160 lozenge 2019-03-31 0000-00-00 No No Current