Halls

Product NDC: 12546-112
11-digit product format: 125460112
Labeler code: 12546
Product ID: 12546-112_29a54d04-41f2-c4b7-e063-6294a90aaed7
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: 2019-04-07
Substance: MENTHOL
Active strength: 5.4 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	12546-112	12546-112-14	D	Discontinued by firm	2026-10-15
excluded package	package	12546-112	12546-112-40	D	Discontinued by firm	2026-10-15
excluded package	package	12546-112	12546-112-96	D	Discontinued by firm	2026-10-15

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 · 36 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	12546-112-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	12546-112-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	12546-112-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-112-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-112-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-112-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-112-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-112-96	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-112-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-112-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-112-96	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-112-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-112-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-112-96	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-112-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-112-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-112-96	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-112-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-112-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-112-96	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-112-40	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-112-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-112-96	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-112-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-112-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-112-96	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-112-40	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-112-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-112-96	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-112-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-112-40	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-112-96	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-112-14	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-112-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-112-96	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-112-14	`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: MENTHO-LYPTUS
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	5.4 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
485287	Internal RxNorm lookup
1250187	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
ff21cf0e-9811-4819-bdfc-17a950e9b114	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12546-112-14	HallsMENTHO-LYPTUS	14 in 1 BAG	LOZENGE	14	10
12546-112-30	HallsMENTHO-LYPTUS	30 in 1 BAG	LOZENGE	30	10
12546-112-40	HallsMENTHO-LYPTUS	40 in 1 BAG	LOZENGE	40	10
12546-112-80	HallsMENTHO-LYPTUS	80 in 1 BAG	LOZENGE	80	10
12546-112-89	HallsMENTHO-LYPTUS	200 in 1 BAG	LOZENGE	200	10
12546-112-96	HallsMENTHO-LYPTUS	96 in 1 BAG	LOZENGE	96	10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12546-112	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	10	Current NDC, Legacy NDC, 6 package rows	20241222_ff21cf0e-9811-4819-bdfc-17a950e9b114.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 18 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinus Congestion	PHENYLEPHRINE HCL	L.N.K. International, Inc.	81f0276a-99a2-4a57-a0d8-224735aa8c79	2026-07-10	Warnings	Exact identifier application number: M012
SINUS AND HEADACHE	ACETAMINOPHEN, PHENYLEPHRINE HCL	Rite Aid Corporation	efaf3be1-ab39-45f7-a45c-7fea8705c8d0	2026-07-10	Warnings	Exact identifier application number: M012
Equate Daytime Nighttime Vapor Ice Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	WALMART INC.	f847d9f2-aa47-4bbe-8f06-19356c637398	2026-07-10	Warnings	Exact identifier application number: M012
Sinus and Allergy Relief PE	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Topco Associates, LLC	2a80fba9-5e30-4ec0-bd8e-8957c0654b6c	2026-07-10	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	50230cad-3d04-8882-e063-6294a90acf3c	2026-07-09	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Maximum Strength	ACETAMINOPHEN, PHENYLEPHRINE HCL	Rugby Laboratories	fc42e97d-1224-4d29-a55d-1a1885e0bf8f	2026-07-09	Warnings	Exact identifier application number: M012
Head Congestion and Mucus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	7418d92d-a540-40d6-91d0-b7eb1f87f8ff	2026-07-08	Warnings	Exact identifier application number: M012
DG HEALTH COUGH AND CHEST CONGESTION	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dolgencorp Inc	5d9d57aa-e43a-4dbe-9d35-36a7b82d4e6d	2026-07-08	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Topco Associates, LLC	bfcabe02-7961-4407-a748-8cd087731398	2026-07-08	Warnings	Exact identifier application number: M012
Aller-chlor	CHLORPHENIRAMINE MALEATE	Rugby Laboratories	04ca3806-72be-47d4-9fea-5b0dee087683	2026-07-08	Warnings	Exact identifier application number: M012
nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	24c22c9f-0c2f-46dc-850e-ed05f00d3e95	2026-07-08	Warnings	Exact identifier application number: M012
NITETIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	0e65c5d1-a18b-452c-9be6-8d44d34577e9	2026-07-08	Warnings	Exact identifier application number: M012
Allergy Relief 4 Hour	CHLORPHENIRAMINE MALEATE	Cardinal Health 110, LLC. DBA Leader	aaecfda5-1a50-4d8a-9909-7153c1a22bda	2026-07-08	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	7cb9f378-5d64-475f-bf26-4058ba6c15b4	2026-07-08	Warnings	Exact identifier application number: M012
DG HEALTH DAY TIME INTENSE FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Dolgencorp Inc	f174d08e-3335-4cc9-8766-4070f18c4f31	2026-07-08	Warnings	Exact identifier application number: M012
Mucus Relief	GUAIFENESIN 400 MG	Health Pharma USA LLC	d60a3e9d-e88e-3b19-e053-2995a90a3e8d	2026-07-07	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Health Pharma USA LLC	d38f47ea-7fda-170b-e053-2995a90adc82	2026-07-07	Warnings	Exact identifier application number: M012
Guaifenesin 200mg	GUAIFENESIN	Health Pharma USA LLC	d68222f7-b796-7b27-e053-2995a90a2efe	2026-07-07	Warnings	Exact identifier application number: M012
Cold and Flu Severe Day Time / Night Time	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	DOLGENCORP, LLC	acdcc6ce-c190-4de6-b126-62fe9043112e	2026-07-07	Warnings	Exact identifier application number: M012
Calmco Allergy Relief	DIPHENHYDRAMINE HCL	CalmCo LLC	471b1a43-1708-8be7-e063-6394a90a9bb7	2026-07-06	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1250187	Halls 5.4 MG Oral Lozenge	PSN	ff21cf0e-9811-4819-bdfc-17a950e9b114	10
485287	menthol 5.4 MG Oral Lozenge	PSN	ff21cf0e-9811-4819-bdfc-17a950e9b114	10
1250187	menthol 5.4 MG Oral Lozenge [Halls]	SBD	ff21cf0e-9811-4819-bdfc-17a950e9b114	10
485287	menthol 5.4 MG Oral Lozenge	SCD	ff21cf0e-9811-4819-bdfc-17a950e9b114	10
1250187	Halls 5.4 MG Oral Lozenge	SY	ff21cf0e-9811-4819-bdfc-17a950e9b114	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12546-112-14	12546011214	14 LOZENGE in 1 BAG (12546-112-14)	14 lozenge	2020-09-01	0000-00-00	No	No	Current
12546-112-30	12546011230	30 LOZENGE in 1 BAG (12546-112-30)	30 lozenge	2019-04-07	0000-00-00	No	No	Current
12546-112-40	12546011240	40 LOZENGE in 1 BAG (12546-112-40)	40 lozenge	2019-04-07	0000-00-00	No	No	Current
12546-112-80	12546011280	80 LOZENGE in 1 BAG (12546-112-80)	80 lozenge	2019-04-07	0000-00-00	No	No	Current
12546-112-89	12546011289	200 LOZENGE in 1 BAG (12546-112-89)	200 lozenge	2019-04-07	0000-00-00	No	No	Current
12546-112-96	12546011296	96 LOZENGE in 1 BAG (12546-112-96)	96 lozenge	2019-04-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Halls mentholyptus bag	Mondelez Global LLC \| Mondelez Canada Inc.	2024-12-19	HUMAN OTC DRUG LABEL	10