Halls

Product NDC: 12546-114
11-digit product format: 125460114
Labeler code: 12546
Product ID: 12546-114_1b6751ee-a006-50ed-e063-6294a90ab290
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: 2019-07-14
Substance: MENTHOL
Active strength: 2.7 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	12546-114	12546-114-30	D	Discontinued by firm		2026-10-21
excluded package	package	12546-114	12546-114-40	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 · 24 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	12546-114-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	12546-114-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-114-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-114-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-114-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-114-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-114-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-114-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-114-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-114-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-114-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-114-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-114-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-114-40	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-114-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-114-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-114-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-114-40	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-114-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-114-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-114-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-114-40	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-114-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-114-40	`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: Strawberry
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	2.7 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
433196	Internal RxNorm lookup
1250183	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
de401eb4-3282-4298-8a51-15d268253464	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12546-114-30	HallsStrawberry	30 in 1 BAG	LOZENGE	30	10
12546-114-40	HallsStrawberry	40 in 1 BAG	LOZENGE	40	10
12546-114-80	HallsStrawberry	80 in 1 BAG	LOZENGE	80	10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	HALLS STRAWBERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	HALLS STRAWBERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	HALLS STRAWBERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HALLS STRAWBERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	HALLS STRAWBERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
POTASSIUM CITRATE	INACTIVE INGREDIENT	EE90ONI6FF	HALLS STRAWBERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HALLS STRAWBERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	HALLS STRAWBERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12546-114	HALLS STRAWBERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	10	Current NDC, Legacy NDC, 3 package rows	20240622_de401eb4-3282-4298-8a51-15d268253464.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 50 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold and Flu Severe, Day, Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR. GUAIFENESIN, PHENYLEPHRINE HCL	L.N.K. International, Inc.	6e6bae79-1231-4b74-81c1-f0c914ed4af3	2026-02-17	Warnings	Exact identifier application number: M012
COUGH AND CHEST CONGESTION	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	dfe69c12-b5fe-46d1-a3bf-ef3729c2e786	2026-02-17	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	3fb49f64-2d77-44db-8186-5904837eedbe	2026-02-17	Warnings	Exact identifier application number: M012
Allergy Relief 4 Hour	CHLORPHENIRAMINE MALEATE	Bryant Ranch Prepack	09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b	2026-02-17	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	HyVee Inc	e8a48a00-3533-4c4d-94e1-8a6c6b35a792	2026-02-17	Warnings	Exact identifier application number: M012
cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	HyVee Inc	1f3efcdd-4976-4aef-a7c6-a5f88d13cb78	2026-02-17	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	HyVee Inc	d5bbb5e1-ff09-4563-b2c6-149ab30e06ad	2026-02-17	Warnings	Exact identifier application number: M012
Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Chain Drug Marketing Association, Inc.	3c8f34ad-589a-4872-939c-44ad5e0e47fe	2026-02-17	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Valu Merchandisers Company	b6144732-99da-4be2-88e0-75f31b323d38	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M012
topcare day time cold and flu relief multi symptom relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Topco Associates LLC	6d08ca2d-6ae4-443f-9920-34b7fb46f2b4	2026-02-16	Warnings	Exact identifier application number: M012
Revasol Acetaminophen Suspension	ACETAMINOPHEN	Rnv LLC	4ab6bb54-7c28-0c6b-e063-6394a90ac4a6	2026-02-13	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Topco Associates LLC	62eed0e8-ba5f-45c2-a543-68b50bcf4b0c	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M012
Revasol Acetaminophen Suspension Dye Free	ACETAMINOPHEN	Rnv LLC	4abc07b3-6a27-260f-e063-6394a90a28d6	2026-02-13	Warnings	Exact identifier application number: M012
robafen dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Major Pharmaceuticals	5e19220d-9cf3-4732-b9aa-c09db5d69ce6	2026-02-13	Warnings	Exact identifier application number: M012
Gencare DayTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	686b9456-f16d-4b99-ae58-f607448bed8b	2026-02-13	Warnings	Exact identifier application number: M012
nasal	PHENYLEPHRINE HYDROCHLORIDE	Kroger Company	1c3dc4e6-452b-4c84-b53c-426cf9ae8f03	2026-02-12	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	United Natural Foods, Inc. dba UNFI	af42d3f7-661e-4322-aefe-2b7f9f1010d6	2026-02-12	Warnings	Exact identifier application number: M012
Childrens Giltuss D	CHILDRENS GILTUSS D	Gil Pharmaceutical Corp	cfc2493b-e99e-4b55-98a9-053f95d49844	2026-02-12	Warnings	Exact identifier application number: M012
Giltuss D	GILTUSS D	Gil Pharmaceutical Corp	298f5457-a7df-474d-9854-68918ee3d330	2026-02-12	Warnings	Exact identifier application number: M012
Vaporizing	CAMPHOR	Walgreen Co.	ef4f95c8-7650-4096-9369-ea8393781bee	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1250183	Halls 2.7 MG Oral Lozenge	PSN	de401eb4-3282-4298-8a51-15d268253464	10
433196	menthol 2.7 MG Oral Lozenge	PSN	de401eb4-3282-4298-8a51-15d268253464	10
1250183	menthol 2.7 MG Oral Lozenge [Halls]	SBD	de401eb4-3282-4298-8a51-15d268253464	10
433196	menthol 2.7 MG Oral Lozenge	SCD	de401eb4-3282-4298-8a51-15d268253464	10
1250183	Halls 2.7 MG Oral Lozenge	SY	de401eb4-3282-4298-8a51-15d268253464	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12546-114-30	12546011430	30 LOZENGE in 1 BAG (12546-114-30)	30 lozenge	2019-07-14	0000-00-00	No	No	Current
12546-114-40	12546011440	40 LOZENGE in 1 BAG (12546-114-40)	40 lozenge	2019-07-14	0000-00-00	No	No	Current
12546-114-80	12546011480	80 LOZENGE in 1 BAG (12546-114-80)	80 lozenge	2019-07-14	0000-00-00	No	No	Current