Halls

Product NDC: 12546-110
Requested package NDC: 12546-110-18
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

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	12546-110	12546-110-18	D	Discontinued by firm		2026-09-14

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…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
aec46410-ffb1-4db4-b232-82110c562f69	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12546-110-00	HallsHoney Lemon	250 in 1 JAR	LOZENGE	250	20
12546-110-01	HallsHoney Lemon	140 in 1 BAG	LOZENGE	140	20
12546-110-02	HallsHoney Lemon	150000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	LOZENGE	150000	20
12546-110-03	HallsHoney Lemon	2400 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	LOZENGE	2400	20
12546-110-04	HallsHoney Lemon	720 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	LOZENGE	720	20
12546-110-14	HallsHoney Lemon	14 in 1 PACKAGE	LOZENGE	14	20
12546-110-16	HallsHoney Lemon	16 in 1 BAG	LOZENGE	16	20
12546-110-18	HallsHoney Lemon	18 in 1 BAG	LOZENGE	18	20
12546-110-24	HallsHoney Lemon	24 in 1 BAG	LOZENGE	24	20
12546-110-30	HallsHoney Lemon	30 in 1 BAG	LOZENGE	30	20
12546-110-40	HallsHoney Lemon	40 in 1 BAG	LOZENGE	40	20
12546-110-80	HallsHoney Lemon	80 in 1 BAG	LOZENGE	80	20
12546-110-96	HallsHoney Lemon	96 in 1 BAG	LOZENGE	96	20
12546-110-99	HallsHoney Lemon	160 in 1 BAG	LOZENGE	160	20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3
BETA CAROTENE	INACTIVE INGREDIENT	01YAE03M7J	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3

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 1 of 195 · 3,895 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Geiss, Destin & Dunn Inc.	1ea07a01-8779-48c2-a287-b7be866cce7b	2026-09-10	Warnings	Exact identifier application number: M012
Childrens Cold and Allergy Relief	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	d64fe757-9948-4727-b5dd-1f8e4e4763e2	2026-09-10	Warnings	Exact identifier application number: M012
Cold and Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE	Kroger Company	fd41e4a4-330f-4409-8ba3-0b3bb6f45bca	2026-09-10	Warnings	Exact identifier application number: M012
Nighttime Sleep Aid Berry Flavor	DIPHENHYDRAMINE HYDROCHLORIDE	Raritan Pharmaceuticals Inc	303d7651-9c8f-4a14-9f2c-7181fa0f003e	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Fruit Punch	GUAIFENESIN	Raritan Pharmaceuticals Inc	a19d7e1c-c04e-41c6-8af6-ecde96299216	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Raritan Pharmaceuticals Inc	2cb3e17f-3858-4773-a53f-0860ae6ff1b9	2026-09-09	Warnings	Exact identifier application number: M012
MUCINEX FAST-MAX Liquid Gels Day Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	3856c1e4-814f-85c4-e063-6394a90ab8a8	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Long Acting Cough	DEXTROMETHORPHAN HBR	RARITAN PHARMACEUTICALS	875b40bd-7955-4048-abbf-7f43d9ea3ac5	2026-09-09	Warnings	Exact identifier application number: M012
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Rite Aid Corporation	4b8ae971-ab57-4937-a878-72d905d7b849	2026-09-09	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	82ba9a73-60ef-49fd-960f-5ca2bb79555e	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN	The Kroger Co.	49829083-5c0a-4620-bfb3-7103642368db	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Childrens Stuffy Nose and Chest Congestion	GUAIFENESIN AND PHENYLEPHRINE HCL	RARITAN PHARMACEUTICALS	7a3bb739-ff50-4d29-b270-d6b084906493	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Children daytime Cough and Chest Congestion	DEXTROMETHORPHAN HBR AND GUAIFENESIN	RARITAN PHARMACEUTICALS	25fff2a6-ecb1-4117-bd11-e5ec3e3d09a9	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Raritan Pharmaceuticals Inc	8a166067-b492-4742-b74c-28fac87c8d70	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice maximum strength Severe Cough plus sore throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	RARITAN PHARMACEUTICALS	a096cb76-0d1c-4ca8-854a-5199da0bc8f7	2026-09-09	Warnings	Exact identifier application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	efb69cc1-a745-6efc-e053-2a95a90abdc9	2026-09-08	Warnings	Exact identifier application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTION	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE	The Procter & Gamble Manufacturing Company	efb5f0b9-9825-ab23-e053-2995a90a26ab	2026-09-08	Warnings	Exact identifier application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTION	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	The Procter & Gamble Manufacturing Company	f4328b44-cdfa-41aa-e053-2995a90a2728	2026-09-08	Warnings	Exact identifier application number: M012
Vicks childrens Cough Congestion	PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN	The Procter & Gamble Manufacturing Company	e2356457-9791-3710-e053-2995a90ad140	2026-09-08	Warnings	Exact identifier application number: M012
Cold Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	077fac1a-0ec5-40d9-8861-a281b48f650a	2026-09-08	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1250191	Halls 7.5 MG Oral Lozenge	PSN	aec46410-ffb1-4db4-b232-82110c562f69	20
1250189	menthol 7.5 MG Oral Lozenge	PSN	aec46410-ffb1-4db4-b232-82110c562f69	20
1250191	menthol 7.5 MG Oral Lozenge [Halls]	SBD	aec46410-ffb1-4db4-b232-82110c562f69	20
1250189	menthol 7.5 MG Oral Lozenge	SCD	aec46410-ffb1-4db4-b232-82110c562f69	20
1250191	Halls 7.5 MG Oral Lozenge	SY	aec46410-ffb1-4db4-b232-82110c562f69	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12546-110-18	12546011018	18 LOZENGE in 1 BAG (12546-110-18)	18 lozenge	2019-03-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HALLS HONEY LEMON bag	Mondelez Global LLC \| Mondelez Canada Inc.	2026-05-13	HUMAN OTC DRUG LABEL	20
Halls Variety Pack - Mentho-lyptus, Honey Lemon & Cherry	Mondelez Global LLC \| Mondelez Canada Inc.	2026-05-08	HUMAN OTC DRUG LABEL	1