Halls

Product NDC: 12546-349
11-digit product format: 125460349
Labeler code: 12546
Product ID: 12546-349_29b505f3-6cfa-cf62-e063-6394a90a812f
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: 2.7 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	12546-349	12546-349-03	D	Discontinued by firm		2026-10-27

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 Mentho-Lyptus
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
96046858-c57b-426e-8279-91b35e05bcdb	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
12546-349-03	HallsSugar Free Mentho-Lyptus	11667 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	LOZENGE	11667		13
12546-349-24	HallsSugar Free Mentho-Lyptus	24 in 1 PACKAGE	LOZENGE	24		13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12546-349	HALLS SUGAR FREE MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	13	Current NDC, Legacy NDC, 2 package rows	20241222_96046858-c57b-426e-8279-91b35e05bcdb.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 131 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS	MENTHOL	Ricola Ag	8ae0e21a-44a0-4a2c-9880-54eeeaea07ea	2024-12-05	Warnings	Exact identifier application number: M012
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola Ag	6d82469b-d51c-4824-9830-6c1874ad4fe4	2024-12-05	Warnings	Exact identifier application number: M012
RICOLA MAX THROAT CARE COOL PEPPERMINT	MENTHOL	Ricola Ag	e8bedf6f-4a2e-4a76-ba8c-bdb249fb6ce5	2024-12-05	Warnings	Exact identifier application number: M012
DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola Ag	a535717d-ba55-45e9-9fc3-711b5d7dbf57	2024-12-05	Warnings	Exact identifier application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPS	MENTHOL	Ricola Ag	4330ee8d-0b37-4a93-886b-5fc6e6598da7	2024-12-05	Warnings	Exact identifier application number: M012
COLD AND FLU DAYTIME SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TARGET CORP	9de99931-31ef-79e2-e053-2a95a90a98ad	2024-12-04	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TopCo Associates LLC	3ef6d155-b95b-4b30-87a8-8ed811b1520f	2024-12-03	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	TOPCARE	a1b2b16d-c767-2945-e053-2995a90a4834	2024-12-03	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TopCare	fa9b2748-0474-4a39-a2b8-bb6f0678c1d1	2024-12-03	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	a9640e09-369c-3c55-e053-2a95a90aebd5	2024-12-03	Warnings	Exact identifier application number: M012
Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	ec7e5e2e-23c7-32ae-e053-2995a90a1251	2024-12-03	Warnings	Exact identifier application number: M012
COLD AND FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCARE	cbb179c8-31fb-4a3a-9f23-4024350f8b7f	2024-12-03	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	a96431a0-b05d-4812-e053-2a95a90a5af6	2024-12-03	Warnings	Exact identifier application number: M012
Cold Max Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	aa0d6762-b803-4630-8f74-780b7ea9acff	2024-12-03	Warnings	Exact identifier application number: M012
Cold plus Head Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	ec7e5e2e-23c5-32ae-e053-2995a90a1251	2024-12-03	Warnings	Exact identifier application number: M012
Cold Plus Head Congestion Day and Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	898eb1c7-395a-4845-9d0a-719fc78d86b7	2024-12-03	Warnings	Exact identifier application number: M012
Cold Plus Head Congestion Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	7854c1fd-b5fc-477d-a79e-ff006ebf6fe5	2024-12-03	Warnings	Exact identifier application number: M012
Cold and Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	e07d880b-a12a-4e5e-94c0-bd36bcfe738c	2024-12-03	Warnings	Exact identifier application number: M012
Head Congestion plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCARE	bd0a3679-1f7c-4c41-e053-2995a90a8fcb	2024-12-03	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	bd09e4f3-3211-8c08-e053-2a95a90a73f9	2024-12-03	Warnings	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	96046858-c57b-426e-8279-91b35e05bcdb	13
433196	menthol 2.7 MG Oral Lozenge	PSN	96046858-c57b-426e-8279-91b35e05bcdb	13
1250183	menthol 2.7 MG Oral Lozenge [Halls]	SBD	96046858-c57b-426e-8279-91b35e05bcdb	13
433196	menthol 2.7 MG Oral Lozenge	SCD	96046858-c57b-426e-8279-91b35e05bcdb	13
1250183	Halls 2.7 MG Oral Lozenge	SY	96046858-c57b-426e-8279-91b35e05bcdb	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12546-349-03	12546034903	11667 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-349-03)	11667 lozenge	2020-10-21	0000-00-00	No	No	Current
12546-349-24	12546034924	24 LOZENGE in 1 PACKAGE (12546-349-24)	24 lozenge	2020-10-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Halls minis sugar free mentho-lyptus 24ct	Mondelez Global LLC \| MSI Express Inc \| Mondelez Canada Inc	2024-12-20	HUMAN OTC DRUG LABEL	13