Halls

Product NDC: 12546-642
11-digit product format: 125460642
Labeler code: 12546
Product ID: 12546-642_407f2207-a647-78ee-e063-6394a90add7e
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: 2019-05-27
Substance: MENTHOL
Active strength: 7.6 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	12546-642	12546-642-02	D	Discontinued by firm		2026-10-16
excluded package	package	12546-642	12546-642-30	D	Discontinued by firm		2026-10-16

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 · 35 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	12546-642-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	12546-642-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-642-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-642-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-642-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-642-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-642-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-642-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-642-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-642-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-642-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-642-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-642-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-642-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-642-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-642-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-642-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-642-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-642-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-642-25	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-642-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-642-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-642-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-642-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-642-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-642-25	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-642-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-642-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-642-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-642-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-642-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-642-25	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-642-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-642-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-642-25	`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	7.6 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
359751	Internal RxNorm lookup
897006	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
2b19fdd2-8088-47f2-be20-f220a6b825fc	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12546-642-02	HallsSugar Free Honey Lemon	2 in 1 BAG	LOZENGE	2	10
12546-642-25	HallsSugar Free Honey Lemon	25 in 1 BAG	LOZENGE	25	10
12546-642-30	HallsSugar Free Honey Lemon	30 in 1 BAG	LOZENGE	30	10
12546-642-70	HallsSugar Free Honey Lemon	70 in 1 BAG	LOZENGE	70	10
12546-642-79	HallsSugar Free Honey Lemon	180 in 1 BAG	LOZENGE	180	10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
BETA CAROTENE	INACTIVE INGREDIENT	01YAE03M7J	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
ISOMALT	INACTIVE INGREDIENT	S870P55O2W	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12546-642	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	9	Current NDC, Legacy NDC, 5 package rows	20240622_2b19fdd2-8088-47f2-be20-f220a6b825fc.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 37 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALKA SELTZER COLD Cold and Flu Severe Day Night Fast Dissolve	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	50762d7c-5efd-4f83-e063-6294a90abf7f	2026-04-27	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L.N.K. International, Inc.	6427b418-89d1-4eac-b25b-0adfefc204fc	2026-04-27	Warnings	Exact identifier application number: M012
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Care One (American Sales Company)	bd5de3b3-7cb5-4403-b664-23ac70b9957f	2026-04-27	Warnings	Exact identifier application number: M012
Leader Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. dba Leader	333c7042-95b8-4d98-9df1-4287017afa36	2026-04-25	Warnings	Exact identifier application number: M012
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	Sportpharm LLC	f2d55d1b-c3d4-4c35-b761-681ed50273bd	2026-04-24	Warnings	Exact identifier application number: M012
Geri-Dryl allergy relief	DIPHENHYDRAMINE HCL	Sportpharm LLC	2c4e0d5e-958d-4274-876a-52126c795c0f	2026-04-24	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	50364a42-3333-51fe-e063-6394a90ab71e	2026-04-24	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu Severe Fast Dissolve	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	5036dc50-e95b-ea8d-e063-6394a90a6cfe	2026-04-24	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	dcb33d5f-87fa-4043-9b6d-36adec96796c	2026-04-24	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	Cardinal Health 107, LLC	abc0e348-8532-4658-bd8c-d7dbe5a28c7d	2026-04-23	Warnings	Exact identifier application number: M012
nitetime severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Publix Super Markets Inc	c5535aaf-c029-48d8-97d1-105a49b5fd95	2026-04-23	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Cough Maximum Strength Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer Healthcare LLC.	50228b3c-d54a-485d-e063-6394a90a4403	2026-04-23	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Flu Severe Fast Chewables	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	5025a333-6378-bf59-e063-6394a90af4f0	2026-04-23	Warnings	Exact identifier application number: M012
POLY-HIST DM	DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR	POLY PHARMACEUTICALS, INC.	5025c99f-b946-e2e0-e063-6394a90a13fb	2026-04-23	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5026611c-93e7-8f90-e063-6394a90a7baa	2026-04-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	c9c1db0f-6ba4-433c-b0ce-e99e9351c0b0	2026-04-23	Warnings	Exact identifier application number: M012
Severe Cold and Flu Plus Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	COSTCO WHOLESALE CORPORATION	5180abbc-c6c4-4b82-b6e7-4504e3bcff0f	2026-04-23	Warnings	Exact identifier application number: M012
Severe Cold and Flu Night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	HyVee Inc	4f963491-e1f0-494d-acb6-5f4d2b267d4a	2026-04-22	Warnings	Exact identifier application number: M012
Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH	f4b01827-7444-3bfc-e053-2a95a90aebed	2026-04-22	Warnings	Exact identifier application number: M012
Vicks Sinex SEVERE ORIGINAL ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH,	cfd43b8f-8064-6b88-e053-2a95a90a329e	2026-04-22	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
897006	Halls 7.6 MG Oral Lozenge	PSN	2b19fdd2-8088-47f2-be20-f220a6b825fc	10
359751	menthol 7.6 MG Oral Lozenge	PSN	2b19fdd2-8088-47f2-be20-f220a6b825fc	10
897006	menthol 7.6 MG Oral Lozenge [Halls]	SBD	2b19fdd2-8088-47f2-be20-f220a6b825fc	10
359751	menthol 7.6 MG Oral Lozenge	SCD	2b19fdd2-8088-47f2-be20-f220a6b825fc	10
897006	Halls 7.6 MG Oral Lozenge	SY	2b19fdd2-8088-47f2-be20-f220a6b825fc	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12546-642-02	12546064202	2 LOZENGE in 1 BAG (12546-642-02)	2 lozenge	2019-05-27	0000-00-00	No	No	Current
12546-642-25	12546064225	25 LOZENGE in 1 BAG (12546-642-25)	25 lozenge	2019-05-27	0000-00-00	No	No	Current
12546-642-30	12546064230	30 LOZENGE in 1 BAG (12546-642-30)	30 lozenge	2019-05-27	0000-00-00	No	No	Current
12546-642-70	12546064270	70 LOZENGE in 1 BAG (12546-642-70)	70 lozenge	2019-05-27	0000-00-00	No	No	Current
12546-642-79	12546064279	180 LOZENGE in 1 BAG (12546-642-79)	180 lozenge	2019-05-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Halls SF honey lemon bag	Mondelez Global LLC \| Mondelez Canada Inc.	2025-10-06	HUMAN OTC DRUG LABEL	10