Halls

Product NDC: 12546-347
11-digit product format: 125460347
Labeler code: 12546
Product ID: 12546-347_2d67d823-08cc-57cc-e063-6394a90a1ce5
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: 2020-10-21
Substance: MENTHOL
Active strength: 2.5 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	12546-347	12546-347-03	D	Discontinued by firm		2026-10-21

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Sugar Free Honey Lemon
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5d56ccd2-1c28-4750-9454-44809091ad2f	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12546-347-03	HallsSugar Free Honey Lemon	11667 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	LOZENGE	11667	14
12546-347-24	HallsSugar Free Honey Lemon	24 in 1 PACKAGE	LOZENGE	24	14
12546-347-48	HallsSugar Free Honey Lemon	2 in 1 BAG	LOZENGE	2	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12546-347	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	14	Current NDC, Legacy NDC, 3 package rows	20250223_5d56ccd2-1c28-4750-9454-44809091ad2f.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 102 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AXIV NightTime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	131f6314-c9a1-7af3-e063-6294a90abe6f	2025-09-17	Warnings	Exact identifier application number: M012
AXIV DayTime - NightTime 48 Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	1320e243-344f-98ed-e063-6294a90a0092	2025-09-17	Warnings	Exact identifier application number: M012
AXIV Sinus Severe Mucus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDE	VIVUNT PHARMA LLC	13245298-8b78-e177-e063-6294a90a6bec	2025-09-17	Warnings	Exact identifier application number: M012
GoodSense Tussin CF Multi-Symptom Cold, Raspberry	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Geiss, Destin & Dunn Inc.	3f05cf84-d485-7688-e063-6394a90ae740	2025-09-17	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	5d7466b4-fdb7-432b-880d-e7aa4a4acbda	2025-09-17	Warnings	Exact identifier application number: M012
allergy relief Childrens	DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	e34d8bf5-e12e-453c-93ea-9c7988c4f13d	2025-09-16	Warnings	Exact identifier application number: M012
DayTime Cold Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	67beb9f6-4e0a-4f7b-b50a-4bcd3a01354f	2025-09-16	Warnings	Exact identifier application number: M012
DOMETUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Domel Laboratories	3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe	2025-09-16	Warnings	Exact identifier application number: M012
CareOne Severe Congestion Nasal	OXYMETAZOLINE HYDROCHLORIDE	American Sales Company	d1dba68b-c4e1-4afc-9aee-6a51341b89f5	2025-09-16	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	FSA Store Inc. (Caring Mills)	e69ef8dc-09d2-46de-aebf-ba735f4cc7ea	2025-09-16	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Lemon Flavor	MENTHOL HONEY LEMON FLAVOR	CVS Pharmacy	3ea9a1f2-75b3-c67a-e063-6294a90a8caf	2025-09-13	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Lemon Flavor	MENTHOL HONEY LEMON FLAVOR	CVS Pharmacy	3eab4cf9-6fdc-a6fb-e063-6394a90a8633	2025-09-13	Warnings	Exact identifier application number: M012
COLD AND FLU DAYTIME-NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORP	9de9fab3-890a-158d-e053-2a95a90af423	2025-09-13	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Precision Dose, Inc.	4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4	2025-09-12	Warnings	Exact identifier application number: M012
Nasal Spray, Circle K	OXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTION	Lil' Drug Store Products, Inc.	3ea06e88-a2c6-621b-e063-6294a90a1075	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Harris Teeter, LLC	a0090dc6-0fe5-4ab2-a2cf-6ed19892f363	2025-09-12	Warnings	Exact identifier application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	CVS Pharmacy	ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	FSA Store Inc. (Caring Mills)	8d7bb31b-a47d-4252-a0a7-79d286179fb9	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	150e5c3a-7c86-4b66-af30-a376df697401	2025-09-12	Warnings	Exact identifier application number: M012
SEVERE COUGH COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	67f8d405-a2ad-4ade-93b4-9b09a0d81d8e	2025-09-11	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
896992	Halls 2.5 MG Oral Lozenge	PSN	5d56ccd2-1c28-4750-9454-44809091ad2f	14
616344	menthol 2.5 MG Oral Lozenge	PSN	5d56ccd2-1c28-4750-9454-44809091ad2f	14
896992	menthol 2.5 MG Oral Lozenge [Halls]	SBD	5d56ccd2-1c28-4750-9454-44809091ad2f	14
616344	menthol 2.5 MG Oral Lozenge	SCD	5d56ccd2-1c28-4750-9454-44809091ad2f	14
896992	Halls 2.5 MG Oral Lozenge	SY	5d56ccd2-1c28-4750-9454-44809091ad2f	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12546-347-03	12546034703	11667 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-347-03)	11667 lozenge	2020-10-21	0000-00-00	No	No	Current
12546-347-24	12546034724	24 LOZENGE in 1 PACKAGE (12546-347-24)	24 lozenge	2020-10-21	0000-00-00	No	No	Current
12546-347-48	12546034748	2 PACKAGE in 1 BAG (12546-347-48) / 24 LOZENGE in 1 PACKAGE (12546-347-24)	2 package	2025-06-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Halls Minis sugar free honey lemon 24ct	Mondelez Global LLC \| MSI Express Inc \| Mondelez Canada Inc	2025-02-05	HUMAN OTC DRUG LABEL	14