Home NDC 12546-110 Halls
Product NDC 12546-110
11-digit product format 125460110
Labeler code 12546
Product ID 12546-110_51b2efc4-6f46-16dc-e063-6294a90a509e
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 2019-03-24
Substance MENTHOL
Active strength 7.5 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 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 Honey Lemon
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 7.5 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 1250189 Internal RxNorm lookup 1250191 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 12546-110 HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC] 18 Current NDC, Legacy NDC, 14 package rows 20240622_aec46410-ffb1-4db4-b232-82110c562f69.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 130 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CVS Vapor Steam CAMPHOR (SYNTHETIC) CVS 49da2c40-afc5-5770-e054-00144ff88e88 2024-12-13 Warnings Exact identifier application number: M012 Kroger Daytime Cold and Flu Softgel ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE The Kroger Company e428dd83-c538-2a92-e053-2a95a90a0e16 2024-12-13 Warnings Exact identifier application number: M012 Kroger Nighttime Cold and Flu Softgel ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE The Kroger Company e46291c7-6f4d-46a2-e053-2a95a90a80a1 2024-12-13 Warnings Exact identifier application number: M012 Foster and Thrive Childrens Allergy Relief DIPHENHYDRAMINE HCL Strategic Sourcing Services LLC 7eaba464-5cdb-4bd4-b272-38fa108658d5 2024-12-13 Warnings Exact identifier application number: M012 SUDAFED OM Sinus Severe Original OXYMETAZOLINE HYDROCHLORIDE Kenvue Brands LLC 1d089074-3969-ce6e-e063-6294a90aa70c 2024-12-12 Warnings Exact identifier application number: M012 RIGHT REMEDIES Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc b4fc014c-7c5f-46a4-bf13-57103b6fa018 2024-12-11 Warnings Exact identifier application number: M012 Diphenhydramine Hydrochloride 25mg DIPHENHYDRAMINE HYDROCHLORIDE 25MG Strive Pharmaceuticals Inc b440eb2e-4de9-2b65-e053-2995a90abda8 2024-12-11 Warnings Exact identifier application number: M012 Meijer Effervescent Cold Relief ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE Meijer Distribution Inc. 6933ca9d-a32d-d856-e053-2a91aa0a408e 2024-12-10 Warnings Exact identifier application number: M012 Effervescent Orange Cold Relief ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE Meijer Distribution Inc. 826b5c0d-7a75-bbf0-e053-2a91aa0aebd6 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 09141018-37ba-4c93-9051-1ed129c448c1 2024-12-10 Warnings Exact identifier application number: M012 Original Herb Cough Drops MENTHOL Ricola USA Inc. 6ac9d95b-f6b9-4515-b126-697f8f839612 2024-12-10 Warnings Exact identifier application number: M012 THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL Ricola USA Inc. 989d1529-2875-47bf-81df-65494d62be7a 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 82813342-2be2-4731-ae90-dbd5eed667a9 2024-12-10 Warnings Exact identifier application number: M012 MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. b640a5d2-a7fe-486d-a65f-e7c993f950d6 2024-12-10 Warnings Exact identifier application number: M012 Sugar Free Mountain Herb Cough Suppressant Throat Drops MENTHOL Ricola USA Inc. c3f3c062-55e5-43c1-a016-ee47a7b388a5 2024-12-10 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE SWISS CHERRY MENTHOL Ricola USA Inc. ee4733b5-6e5a-438a-97da-110f3ef6c809 2024-12-10 Warnings Exact identifier application number: M012 SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola USA Inc. f62fcc38-2d43-40b3-841f-c8eea9ebd1e1 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 8a6db093-7e52-443f-8dd6-94867606fef8 2024-12-10 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE COOL PEPPERMINT MENTHOL Ricola USA Inc. 5885343e-4a6e-44f7-87a4-d52599156197 2024-12-10 Warnings Exact identifier application number: M012 EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL Ricola USA Inc. 0baf383c-886d-47ca-8a6d-221298c79446 2024-12-10 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 12546-110-00 12546011000 250 LOZENGE in 1 JAR (12546-110-00) 250 lozenge 2022-07-06 0000-00-00 No No Current 12546-110-01 12546011001 140 LOZENGE in 1 BAG (12546-110-01) 140 lozenge 2023-04-10 No No Current 12546-110-02 12546011002 150000 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-110-02) 150000 lozenge 2019-12-02 0000-00-00 No No Current 12546-110-03 12546011003 2400 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-110-03) 2400 lozenge 2019-12-02 0000-00-00 No No Current 12546-110-04 12546011004 720 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-110-04) 720 lozenge 2019-12-02 0000-00-00 No No Current 12546-110-14 12546011014 14 LOZENGE in 1 PACKAGE (12546-110-14) 14 lozenge 2019-03-24 0000-00-00 No No Current 12546-110-16 12546011016 16 LOZENGE in 1 BAG (12546-110-16) 16 lozenge 2019-03-24 0000-00-00 No No Current 12546-110-18 12546011018 18 LOZENGE in 1 BAG (12546-110-18) 18 lozenge 2019-03-24 0000-00-00 No No Current 12546-110-24 12546011024 24 LOZENGE in 1 BAG (12546-110-24) 24 lozenge 2019-12-02 0000-00-00 No No Current 12546-110-30 12546011030 30 LOZENGE in 1 BAG (12546-110-30) 30 lozenge 2019-03-24 0000-00-00 No No Current 12546-110-40 12546011040 40 LOZENGE in 1 BAG (12546-110-40) 40 lozenge 2019-03-24 0000-00-00 No No Current 12546-110-80 12546011080 80 LOZENGE in 1 BAG (12546-110-80) 80 lozenge 2019-03-24 0000-00-00 No No Current 12546-110-96 12546011096 96 LOZENGE in 1 BAG (12546-110-96) 96 lozenge 2019-03-24 0000-00-00 No No Current 12546-110-99 12546011099 160 LOZENGE in 1 BAG (12546-110-99) 160 lozenge 2019-03-24 0000-00-00 No No Current