Halls

Product NDC: 12546-640
11-digit product format: 125460640
Labeler code: 12546
Product ID: 12546-640_1fbb2a9f-6a86-45fe-e063-6394a90a946f
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: 2019-06-03
Substance: MENTHOL
Active strength: 5.8 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	12546-640	12546-640-25	D	Discontinued by firm		2026-10-23

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 Mountain Menthol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	5.8 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
476973	Internal RxNorm lookup
896994	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
54e0d57e-1f48-45e2-86b3-0e50775996f4	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12546-640-01	HallsSugar Free Mountain Menthol	150000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	LOZENGE	150000	8
12546-640-25	HallsSugar Free Mountain Menthol	25 in 1 BAG	LOZENGE	25	8
12546-640-70	HallsSugar Free Mountain Menthol	70 in 1 BAG	LOZENGE	70	8
12546-640-98	HallsSugar Free Mountain Menthol	225 in 1 JAR	LOZENGE	225	8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
ISOMALT	INACTIVE INGREDIENT	S870P55O2W	HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12546-640	HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	8	Current NDC, Legacy NDC, 4 package rows	20240816_54e0d57e-1f48-45e2-86b3-0e50775996f4.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 122 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Menthol Cough Drops	MENTHOL	Walgreens	2c62f690-8dfb-d28e-e063-6394a90a45a2	2025-01-23	Warnings	Exact identifier application number: M012
Walgreens Cherry Cough Drops	MENTHOL	Walgreens	2c65d836-e724-50d6-e063-6394a90a0827	2025-01-23	Warnings	Exact identifier application number: M012
Walgreens Honey Lemon Cough Drops	MENTHOL	Walgreens	2c67424c-2fb0-cc15-e063-6394a90a02ca	2025-01-23	Warnings	Exact identifier application number: M012
Pharmacys Prescription Analgesic Gel	MENTHOL	American Consumer Products Corp	6f0725f2-833f-f3a0-e053-2a91aa0a3911	2025-01-23	Warnings	Exact identifier application number: M012
Pharmacys Prescription Vapor Rub	MENTHOL	American Consumer Products Corp	6ef328ff-f5c3-515d-e053-2a91aa0a32d3	2025-01-23	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Best Choice	0035e6a4-b3ef-4e0b-aa7f-7453dd065f4d	2025-01-22	Warnings	Exact identifier application number: M012
GOOD REMEDIES Allergy Relief SOFTGEL	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	26a02737-2cfd-769f-e063-6394a90af352	2025-01-22	Warnings	Exact identifier application number: M012
Pharbechlor	CHLORPHENIRAMINE MALEATE 4MG	Ulai Health LLC	6a1a5cef-e946-4ba8-9402-557c6adf45f9	2025-01-20	Warnings	Exact identifier application number: M012
Pharbinex	GUAIFENESIN 400MG	Ulai Health LLC	4eafa81a-aeee-4c97-85d6-594902b10919	2025-01-20		Exact identifier application number: M012
Pharbinex-PE	GUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MG	Ulai Health LLC	e459bb83-b1d6-42fc-aa46-99ad117e6144	2025-01-20		Exact identifier application number: M012
Pharbinex-DM	GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG	Ulai Health LLC	af80d10e-3fb2-405a-a803-1f876b8dcd10	2025-01-20		Exact identifier application number: M012
Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Bayer HealthCare LLC.	34b2e77f-5d04-15a7-e054-00144ff8d46c	2025-01-17	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	a23a6db6-4585-2882-e053-2a95a90ab01a	2025-01-17	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold Night PowerFast Fizz	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	fc754dff-cecd-fc6b-e053-6394a90ab371	2025-01-17	Warnings	Exact identifier application number: M012
Kroger DayTime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	The Kroger Co.	2499210b-c162-76b9-e063-6294a90adbc3	2025-01-17	Warnings	Exact identifier application number: M012
Childrens Multi Symptom Cold Very Berry	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS	2a849ae9-338f-4642-e063-6394a90a1ca4	2025-01-17	Warnings	Exact identifier application number: M012
Kroger NightTime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	The Kroger Co.	24a73de3-e9eb-4cd4-e063-6394a90aa263	2025-01-17	Warnings	Exact identifier application number: M012
Diphenhydramine HCl Oral Solution	DIPHENHYDRAMINE HCL ORAL	Everpharm LLC	d7aaf874-69ac-49cf-93be-6d4a38b9a557	2025-01-16	Warnings	Exact identifier application number: M012
Cough Relief	DEXTROMETHORPHAN HBR	Best Choice (Valu Merchandisers Company)	204a7fc4-142d-45fd-8a77-0612857132be	2025-01-16	Warnings	Exact identifier application number: M012
daytime cold and flu nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	df31056b-d0eb-4094-98d9-3d444210d50d	2025-01-16	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
896994	Halls 5.8 MG Oral Lozenge	PSN	54e0d57e-1f48-45e2-86b3-0e50775996f4	8
476973	menthol 5.8 MG Oral Lozenge	PSN	54e0d57e-1f48-45e2-86b3-0e50775996f4	8
896994	menthol 5.8 MG Oral Lozenge [Halls]	SBD	54e0d57e-1f48-45e2-86b3-0e50775996f4	8
476973	menthol 5.8 MG Oral Lozenge	SCD	54e0d57e-1f48-45e2-86b3-0e50775996f4	8
896994	Halls 5.8 MG Oral Lozenge	SY	54e0d57e-1f48-45e2-86b3-0e50775996f4	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12546-640-01	12546064001	150000 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-640-01)	150000 lozenge	2024-11-05		No	No	Current
12546-640-25	12546064025	25 LOZENGE in 1 BAG (12546-640-25)	25 lozenge	2019-06-03	0000-00-00	No	No	Current
12546-640-70	12546064070	70 LOZENGE in 1 BAG (12546-640-70)	70 lozenge	2019-06-03	0000-00-00	No	No	Current
12546-640-98	12546064098	225 LOZENGE in 1 JAR (12546-640-98)	225 lozenge	2024-07-02		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HALLS Sugar Free Mountain Menthol	Mondelez Global LLC \| Mondelez Canada Inc.	2024-08-15	HUMAN OTC DRUG LABEL	8