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 11 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ORIGINAL Nasal PUMP MIST No Drip	OXYMETAZOLINE HYDROCHLORIDE	WinCo FOODS, LLC	ac27fd75-4fe4-433c-a434-2dac16c895c7	2026-08-07	Warnings	Exact identifier application number: M012
Winco Foods Childrens Allergy Relief Dye Free	DIPHENHYDRAMINE HYDROCHLORIDE	WINCO FOODS, LLC	a1367804-37c9-4906-858f-8feeb748d8d3	2026-08-07	Warnings	Exact identifier application number: M012
Severe Congestion Nasal Anti-Drip Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	WinCo FOODS, LLC	a09c2d02-334a-4840-b2d0-327121cec994	2026-08-07	Warnings	Exact identifier application number: M012
Daytime Nighttime Intense Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Walgreen Company	03aa43fd-4962-4c2c-9edd-e422a629a0e3	2026-08-06	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	f311b56f-b959-4070-9b23-82c642dd98b8	2026-08-06	Warnings	Exact identifier application number: M012
Cold Relief Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L.N.K. International, Inc.	2ed25f69-89ef-4c50-946a-7e7b9df1ca8a	2026-08-06	Warnings	Exact identifier application number: M012
Eucamint	MENTHOL, CAMPHOR	Indiana Botanic Gardens	d79bc8de-9efb-4996-a55c-accda0f8edb2	2026-08-06	Warnings	Exact identifier application number: M012
NICOTINE GUM	NICOTINE POLACRILEX	Guangzhou Shuimu Jiahe Trading Co., Ltd.	4e88dab4-8e13-f074-e063-6394a90a3908	2026-08-06	Warnings	Exact identifier application number: M012
Oneoo Nicotine Gum (Mint)	NICOTINE POLACRILEX	Guangzhou Shuimu Jiahe Trading Co., Ltd.	54b1329b-b422-29a5-e063-6294a90a8780	2026-08-06	Warnings	Exact identifier application number: M012
Sine Aid PEAK MISERY	OXYMETAZOLINE HYDROCHLORIDE	Infirst Healthcare Inc.	586a2a14-7048-0c8b-e063-6394a90a65b7	2026-08-06	Warnings	Exact identifier application number: M012
DRX CHOICE Daytime and Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Raritan Pharmaceuticals Inc	b745f45d-2042-4daa-9932-241836d7734b	2026-08-06	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	NUVICARE LLC	6713fdff-0e4e-4a9d-b218-34f786339c57	2026-08-06	Warnings	Exact identifier application number: M012
Daytime Cold, Nighttime Cold multi-symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	3b462a5d-d48b-4b73-b5d4-d7944730bbdd	2026-08-06	Warnings	Exact identifier application number: M012
TOPCARE DAY TIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Topco Associates LLC	d1b89d17-b3b9-4133-88a3-8cd7c4efafa9	2026-08-05	Warnings	Exact identifier application number: M012
Sinufrin Quick Relief Decongestant	SINUFRIN	Neilmed pharmaceuticals Inc.	0c36a34e-462d-713c-e063-6294a90a1776	2026-08-05	Warnings	Exact identifier application number: M012
No Drip	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals Inc	e9b799ad-9164-7f30-e053-2a95a90a00c5	2026-08-05	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	507284c3-cad9-d65c-e063-6394a90a58a8	2026-08-05	Warnings	Exact identifier application number: M012
cough and cold relief HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	United Natural Foods, Inc. dba UNFI	90482e7a-d7c7-4127-972d-5ee55e55ed1c	2026-08-04	Warnings	Exact identifier application number: M012
DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Walgreen Company	78edeb7a-4712-4f04-9d76-d5b2d20ce76d	2026-08-04	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Better Living Brands, LLC	33f34aa2-3b37-4e51-8428-4a12708aa064	2026-08-04	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