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		2026-10-20
excluded package	package	12546-104	12546-104-30	D	Discontinued by firm		2026-10-20

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 44 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HCL	CVS Pharmacy	eafd9823-c0ad-454a-b725-562d88ebec92	2026-03-23	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu	ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Grocery Outlet, Inc.	4db0470b-1bf0-9137-e063-6394a90a1d54	2026-03-23	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Grocery Outlet, Inc.	4db066d4-ddbe-ddce-e063-6394a90ac5f8	2026-03-23	Warnings	Exact identifier application number: M012
Throat Comfort Orange Mint Cinnamon Drops	MENTHOL	Ricola Ag	27487e5c-044c-41eb-865f-2f34351afd52	2026-03-23	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	f288eeca-9803-4962-a802-fe34f5983c7a	2026-03-23	Warnings	Exact identifier application number: M012
Throat Comfort Lemon Mint Ginger Drops	MENTHOL	Ricola Ag	d63b4d24-e926-418c-bb17-420aeaad5a62	2026-03-23	Warnings	Exact identifier application number: M012
Mucus Relief Congestion Cough Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	6e7dfee1-3de9-46c8-9b58-83fcf8ee72e0	2026-03-23	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN	Hyvee Inc	44eafc83-8e7b-89b8-e063-6394a90ab0bc	2026-03-23	Warnings	Exact identifier application number: M012
Throat Comfort Lemon Mint Ginger Drops	MENTHOL	Ricola USA Inc.	5d7889b1-3866-49b0-97e1-1e883a52d3cb	2026-03-23	Warnings	Exact identifier application number: M012
Throat Comfort Orange Mint Cinnamon Drops	MENTHOL	Ricola USA Inc.	1487652c-dbc1-40f4-9d59-891ec74cc363	2026-03-23	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	4e2a8b53-0074-42fd-8357-a39cc6afe608	2026-03-23	Warnings	Exact identifier application number: M012
Mucus Relief Severe Cold Daytime Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TARGET Corporation	5ccaf3b0-096a-4644-9c6e-9f251c167b3c	2026-03-23	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL	Grocery Outlet, Inc.	4d88180f-610c-d9ab-e063-6394a90a09f0	2026-03-21	Warnings	Exact identifier application number: M012
Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	HyVee Inc	cc371bc3-ba7a-430d-9ee4-22e9c50935f1	2026-03-20	Warnings	Exact identifier application number: M012
Daytime Nighttime Multi Symptom Cold Childrens	DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Walgreens	da4c36f5-ec79-4489-bb18-8ddab79c34bd	2026-03-20	Warnings	Exact identifier application number: M012
Sanatos Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	Pharmadel LLC	3bddcd5a-7776-49ff-e063-6294a90a5dd1	2026-03-20	Warnings	Exact identifier application number: M012
Vaporizing	CAMPHOR	Amazon.com Services LLC	21cfe9cb-5ff5-4331-8358-4d1d9646d6ac	2026-03-19	Warnings, Adverse reactions	Exact identifier application number: M012
Equate Wild Cherry Throat Drop	PECTIN	Walmart	4d66547a-b72a-a0ac-e063-6394a90adc71	2026-03-19	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Safeway, Inc.	45d44cd2-5187-4a5c-983a-edb1e8eba0b2	2026-03-19	Warnings	Exact identifier application number: M012
Sedalmex XL Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Belmora LLC	f2edfedf-e06e-4d1b-8c2d-732e08ec113c	2026-03-19	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