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		2026-10-23

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 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 122 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Menthol Cough Drops	MENTHOL	Target Corporation Inc.	eb4c2c3f-91d7-e4c6-e053-2a95a90a4e8a	2025-01-26	Warnings	Exact identifier application number: M012
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

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