Halls

Product NDC: 12546-104
11-digit product format: 125460104
Labeler code: 12546
Product ID: 12546-104_307a57f2-a64a-23f5-e063-6394a90a39fc
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: 2019-06-10
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	12546-104	12546-104-25	D	Discontinued by firm		2026-10-16
excluded package	package	12546-104	12546-104-30	D	Discontinued by firm		2026-10-16

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	12546-104-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	12546-104-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-104-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-104-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-104-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-104-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-104-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-104-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-104-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-104-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-104-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-104-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-104-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-104-25	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-104-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-104-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-104-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-104-25	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-104-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-104-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-104-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-104-25	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-104-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-104-25	`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 Black Cherry
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
bd2a311a-bf0c-4365-af9b-76675c243b22	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12546-104-25	HallsSugar Free Black Cherry	25 in 1 BAG	LOZENGE	25	9
12546-104-30	HallsSugar Free Black Cherry	30 in 1 BAG	LOZENGE	30	9
12546-104-70	HallsSugar Free Black Cherry	70 in 1 BAG	LOZENGE	70	9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	HALLS SUGAR FREE BLACK CHERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
Menthol	ACTIVE MOIETY	L7T10EIP3A	HALLS SUGAR FREE BLACK CHERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	HALLS SUGAR FREE BLACK CHERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	HALLS SUGAR FREE BLACK CHERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	HALLS SUGAR FREE BLACK CHERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HALLS SUGAR FREE BLACK CHERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HALLS SUGAR FREE BLACK CHERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
ISOMALT	INACTIVE INGREDIENT	S870P55O2W	HALLS SUGAR FREE BLACK CHERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	HALLS SUGAR FREE BLACK CHERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	HALLS SUGAR FREE BLACK CHERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12546-104	HALLS SUGAR FREE BLACK CHERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	9	Current NDC, Legacy NDC, 3 package rows	20250319_bd2a311a-bf0c-4365-af9b-76675c243b22.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 27 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Fast-Max Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Reckitt Benckiser LLC	3270f369-7a40-186d-e063-6394a90a8526	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	fe44d1ee-1e03-b74f-e053-6294a90a8bb4	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	31ac6883-ffcd-39de-e063-6294a90a52dd	2026-05-19	Warnings	Exact identifier application number: M012
MUCINEX DAY TIME PAIN, HEADACHE and MUCUS CONGESTION and MUCINEX NIGHT TIME HEADACHE, COUGH and FEVER Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	325b41e1-f8d2-02ee-e063-6394a90aafff	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	326f1fd3-73ab-e515-e063-6294a90ab222	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	6c85df30-a601-4de6-9fd6-818265d799ff	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	7050b583-c09b-4457-9a9c-70c0923b62c0	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	27312ee4-d1f4-4a95-9c45-91fa5a01f5ba	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Rapid Clear Daytime Pain, Headache, and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	37de53a7-5546-3804-e063-6294a90a0fb5	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	36b07e49-c72c-45e5-e063-6394a90a804a	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Sinus Max Clear and Cool Severe Congestion	OXYMETAZOLINE HCI	Reckitt Benckiser LLC	2ee95e17-bd94-d717-e063-6294a90a2173	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Sinus Max Sinus Pressure Severe Congestion	OXYMETAZOLINE HCI	Reckitt Benckiser LLC	2eeafd83-230c-af92-e063-6294a90a984e	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Congestion and Headache Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d7017328-f8af-4601-9232-dc1104feaa0a	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Rapid Clear Pain Headache and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	32375b12-75ed-d605-e063-6294a90ad004	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Pressure, Pain and Cough Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	07da45b5-d05e-41b1-b233-f7034d556a8d	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Severe Congestion and Pain Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	ad4e0e4d-cc1f-4176-835f-3ba76564c634	2026-05-19	Warnings	Exact identifier application number: M012
Childrens Mucinex Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	60daf6e2-ded8-44e6-bd8d-9d221384adde	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Childrens Mini Melts Cold and Flu	ACETAMINOPHEN AND GUAIFENESIN	Reckitt Benckiser LLC	401fe0a0-ec97-5248-e063-6394a90af27f	2026-05-19	Warnings	Exact identifier application number: M012
Childrens Cough and Congestion, Childrens Cold and Cough Day, Night	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN	WALMART INC.	312ae879-1124-40a4-b2ba-3f3070840021	2026-05-19	Warnings	Exact identifier application number: M012
GOOD SENSE DAYTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	L. Perrigo Company	2597e84c-18b4-41a9-8e6a-ff0c4c1f0612	2026-05-18	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	bd2a311a-bf0c-4365-af9b-76675c243b22	9
476973	menthol 5.8 MG Oral Lozenge	PSN	bd2a311a-bf0c-4365-af9b-76675c243b22	9
896994	menthol 5.8 MG Oral Lozenge [Halls]	SBD	bd2a311a-bf0c-4365-af9b-76675c243b22	9
476973	menthol 5.8 MG Oral Lozenge	SCD	bd2a311a-bf0c-4365-af9b-76675c243b22	9
896994	Halls 5.8 MG Oral Lozenge	SY	bd2a311a-bf0c-4365-af9b-76675c243b22	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12546-104-25	12546010425	25 LOZENGE in 1 BAG (12546-104-25)	25 lozenge	2019-06-10	0000-00-00	No	No	Current
12546-104-30	12546010430	30 LOZENGE in 1 BAG (12546-104-30)	30 lozenge	2019-06-10	0000-00-00	No	No	Current
12546-104-70	12546010470	70 LOZENGE in 1 BAG (12546-104-70)	70 lozenge	2019-06-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Halls sugar free black cherry bag	Mondelez Global LLC \| Mondelez Canada Inc	2025-03-16	HUMAN OTC DRUG LABEL	9