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		2026-10-23
excluded package	package	12546-104	12546-104-30	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 · 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 109 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
leader childrens allergy relief	DIPHENHYDRAMINE HCL	Cardinal Health 110, LLC. dba Leader	40d697b7-dc59-4d24-8d46-db635e01b9d5	2025-07-22	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Chain Drug Consortium	34005c55-3176-4f28-9a3b-7dc6fefd01fe	2025-07-19	Warnings	Exact identifier application number: M012
Sinus Relief Daytime Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger Company	73a77a13-983b-4e65-bb3c-2ba5e9f33a3e	2025-07-19	Warnings	Exact identifier application number: M012
QUALITY CHOICE No Drip Nasal Mist	OXYMETAZOLINE HYDROCHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	7cb6ad04-7847-46b9-b371-0a3473001c79	2025-07-18	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength	PSEUDOEPHEDRINE HCL	Chain Drug Consortium	270e9221-d305-4148-b523-741e02fe733f	2025-07-18	Warnings	Exact identifier application number: M012
ACTISPEC PSE	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIPHARMA, LLC	5def1555-87f4-41d5-8a5c-be560aa8f1e2	2025-07-17	Warnings	Exact identifier application number: M012
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	1a17b24a-8022-4e2f-e063-6294a90af276	2025-07-17	Warnings	Exact identifier application number: M012
BULPOL Smoking Patches	MENTHOL	Jiashen International Trade Limited	3a1cc0e1-fabf-52b9-e063-6394a90ae35e	2025-07-17	Warnings	Exact identifier application number: M012
Ampigrin Ultra Forte Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	OPMX LLC	e11e71c3-fe7c-77c7-e053-2995a90a34b2	2025-07-17	Warnings	Exact identifier application number: M012
Nitecin	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	OPMX LLC	dfb56532-6f72-1e4d-e053-2a95a90a1c05	2025-07-17	Warnings	Exact identifier application number: M012
tabcin NIGHT	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	OPMX LLC	0b3ed2bb-88ed-699e-e063-6394a90ac023	2025-07-17	Warnings	Exact identifier application number: M012
Pentrexcilina Night Time	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	OPMX LLC	e11e5c17-28f2-7186-e053-2995a90a51f6	2025-07-17	Warnings	Exact identifier application number: M012
Viro Flu PM Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	OPMX LLC	e1553da8-3a89-e258-e053-2a95a90a4725	2025-07-17	Warnings	Exact identifier application number: M012
ACTICON PEDIATRIC	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIPHARMA, LLC	3052cc67-e6c0-4d3f-9ec9-ffe58d9fae23	2025-07-17	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Demoulas Super Markets, Inc	397f5acd-31c0-683e-e063-6394a90a7e54	2025-07-16	Warnings	Exact identifier application number: M012
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE	Kenvue Brands LLC	19ad2cca-c1cb-019c-e063-6294a90a5644	2025-07-16	Warnings	Exact identifier application number: M012
DG HEALTH COLD FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Dolgencorp Inc	8ea03891-2fbc-4413-8e6d-de903d426f8d	2025-07-16	Warnings	Exact identifier application number: M012
up and up nighttime flu and severe cold and cough	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	df488727-b913-440b-9a0b-cce3ae143bf2	2025-07-15	Warnings	Exact identifier application number: M012
Topcare DayTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Topco Associates LLC	bb9663e3-fd11-4e72-bf85-fee4841b795f	2025-07-15	Warnings	Exact identifier application number: M012
DG HEALTH COLD FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Dolgencorp Inc	320e4f32-66aa-48be-9afd-fa2b2c217dc1	2025-07-14	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