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		2026-10-15

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 23 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theraflu Severe Congestion Relief Cooling Nasal Mist	OXYMETAZOLINE HCL	Haleon US Holdings LLC	90125a19-eed7-4ca4-a6dc-f38026c74d54	2026-06-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	54254b61-7861-4eeb-bd3c-54fd5266f4a7	2026-06-08	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Major Pharmaceuticals	aa662428-e61f-4e22-af4d-8cf63df68c99	2026-06-08	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN, GUAIFENESIN AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	TARGET CORPORATION	47a218a0-6395-36bd-e063-6394a90a265a	2026-06-05	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCL	TARGET CORPORATION	4779288a-9850-8490-e063-6394a90abe51	2026-06-05	Warnings	Exact identifier application number: M012
Mucinex Fast-Max DM Max and Mucinex Fast-Max Nighttime DM Max Value Pack	DEXTROMETHORPHAN HBR, GUAIFENESIN AND TRIPROLIDINE HCL	Reckitt Benckiser LLC	4df37cfb-299f-661f-e063-6394a90ab337	2026-06-04	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	53715ea4-42b3-5887-e063-6294a90a4249	2026-06-04	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Chain Drug Marketing Association, Inc.	b0d38db9-22a9-4dd8-8e0f-dd81805e724b	2026-06-04	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CVS PHARMACY	65d4d7ea-c080-404e-9836-7d6bdcc5ea7d	2026-06-04	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	fe9d6a6e-38a1-44ae-a30f-596c5ec7d057	2026-06-03	Warnings	Exact identifier application number: M012
Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	b0c1d635-0f85-433a-b479-51c68d259faa	2026-06-03	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	Walgreen Company	de4e8af4-d3d0-44b3-aea3-79016803ccdc	2026-06-03	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HBR AND GUAIFENESIN	ARMY AND AIR FORCE EXCHANGE SERVICE	dc0a3761-bbe2-4261-a183-594f5fb12b0b	2026-06-03	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	WALMART INC.	f278cc81-65b2-4e45-be5b-41152cbb67c4	2026-06-03	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Family Dollar Services Inc	358ba91d-06a4-49c9-994d-4e4bf9499dcd	2026-06-03	Warnings	Exact identifier application number: M012
GUAIFENESIN DM	GUAIFENESIN AND DEXTROMETHORPHAN	Cardinal Health 107, LLC	c5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed	2026-06-02	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5349dbde-730c-610f-e063-6394a90a952a	2026-06-02	Warnings	Exact identifier application number: M012
Guaifenesin and Codeine Phosphate	GUAIFENESIN AND CODEINE PHOSPHATE	Cardinal Health 107, LLC	a9130f36-4761-4e6b-a383-eca3db06ea93	2026-06-02	Warnings	Exact identifier application number: M012
Topcare Day Time Nite Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Topco Associates LLC	aed387e0-5a8b-4caf-a373-3e04496a4983	2026-06-02	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid Day	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	53371691-2510-5039-e063-6394a90a6ea9	2026-06-01	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