HALLS

Product NDC: 12546-241
11-digit product format: 125460241
Labeler code: 12546
Product ID: 12546-241_53d459a4-d29c-9885-e063-6394a90add1d
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: 2019-01-25
Substance: MENTHOL
Active strength: 1.8 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	12546-241	12546-241-40	D	Discontinued by firm		2026-10-27

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	12546-241-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	12546-241-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-241-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-241-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-241-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-241-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-241-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-241-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-241-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-241-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-241-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-241-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-241-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-241-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-241-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-241-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-241-40	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-241-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-241-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-241-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-241-40	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-241-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-241-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-241-30	`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: Honey
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	1.8 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
1429019	Internal RxNorm lookup
2109514	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
837f5ded-8efb-402b-a1bc-b5c142755660	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12546-241-30	HALLSHoney	30 in 1 BAG	LOZENGE	30	3
12546-241-40	HALLSHoney	40 in 1 BAG	LOZENGE	40	3
12546-241-80	HALLSHoney	80 in 1 BAG	LOZENGE	80	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12546-241	HALLS HONEY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3	Current NDC, Legacy NDC, 3 package rows	20240622_837f5ded-8efb-402b-a1bc-b5c142755660.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 116 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pharmacys Prescription Vapor Rub	MENTHOL	American Consumer Products Corp	31aa54d8-df8d-f1ae-e063-6294a90a9622	2025-03-31	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Bryant Ranch Prepack	570a71eb-2d19-4c7b-8c00-e1524bfa3844	2025-03-31	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	KESIN PHARMA CORPORATION	365c01b7-a197-4876-85fc-42204f787e3a	2025-03-28	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Bryant Ranch Prepack	59aeb692-2f79-45aa-8e6a-dab77cd3b2f9	2025-03-28	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Oncor Pharmaceuticals	06ecba97-c790-4672-a8c3-f9caf6272d26	2025-03-27	Warnings	Exact identifier application number: M012
Sugar Free Honey-Lemon Fishermans Friend Menthol Cough Suppressant	MENTHOL	Lofthouse of Fleetwood, Ltd.	87ebb4d9-78d7-1c87-e053-2a95a90adb7d	2025-03-27	Warnings	Exact identifier application number: M012
REVASOL CHILDRENS ALLERGY	DIPHENHYDRAMINE HCL	Rnv LLC	3143137f-ef42-5358-e063-6394a90a8ed1	2025-03-26	Warnings	Exact identifier application number: M012
Rompe Pecho SF FLU	DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	Efficient Laboratories Inc	bc10695a-9664-4ce3-82bb-820da06129fa	2025-03-26	Warnings	Exact identifier application number: M012
SUPRESS-PE Pediatric	GUIAFENESIN, PHENYLEPHRINE HCL	Kramer Novis	a474171d-5c29-4a80-9d37-00613796211a	2025-03-26	Warnings	Exact identifier application number: M012
Guaifenesin DM	DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN	Innovida Pharmaeutique Corporation	dd3f806b-2470-4055-94e1-18adac811025	2025-03-25	Warnings	Exact identifier application number: M012
Foster and Thrive childrens cold cough relief dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Strategic Sourcing Services LLC	38b710e3-1d01-4ff4-a6b6-44936f277f49	2025-03-25	Warnings	Exact identifier application number: M012
Revasol Tussin DM Max with Honey	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Rnv LLC	30da9255-c93a-84d6-e063-6394a90a7c2a	2025-03-21	Warnings	Exact identifier application number: M012
REVASOL NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Rnv LLC	30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9	2025-03-21	Warnings	Exact identifier application number: M012
Chest Congestion Relief	GUAIFENESIN	Meijer, Inc.	261a79b3-5704-76f2-e063-6394a90a5ac6	2025-03-20	Warnings	Exact identifier application number: M012
Rompe Tos X Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05cc932d-b412-0710-e063-6394a90a87f6	2025-03-19	Warnings	Exact identifier application number: M012
Rompe Tos X Adults	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05abb2db-d22e-90b5-e063-6294a90ace3f	2025-03-19	Warnings	Exact identifier application number: M012
Sinus Head Congestion	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	VIVUNT PHARMA LLC	30a07773-bd6f-b9f2-e063-6394a90ab8aa	2025-03-18	Warnings	Exact identifier application number: M012
Halls Sugar Free Black Cherry	MENTHOL	Mondelez Global LLC	bd2a311a-bf0c-4365-af9b-76675c243b22	2025-03-16	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	TARGET CORPORATION	fbca9627-5e12-048a-e053-6294a90a6e0f	2025-03-15	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	DOLGENCORP, INC.	0655688e-7c42-507f-e063-6294a90ae498	2025-03-15	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2109514	HALLS 1.8 MG Oral Lozenge	PSN	837f5ded-8efb-402b-a1bc-b5c142755660	3
1429019	menthol 1.8 MG Oral Lozenge	PSN	837f5ded-8efb-402b-a1bc-b5c142755660	3
2109514	menthol 1.8 MG Oral Lozenge [Halls]	SBD	837f5ded-8efb-402b-a1bc-b5c142755660	3
1429019	menthol 1.8 MG Oral Lozenge	SCD	837f5ded-8efb-402b-a1bc-b5c142755660	3
2109514	Halls 1.8 MG Oral Lozenge	SY	837f5ded-8efb-402b-a1bc-b5c142755660	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12546-241-30	12546024130	30 LOZENGE in 1 BAG (12546-241-30)	30 lozenge	2019-01-25	0000-00-00	No	No	Current
12546-241-40	12546024140	40 LOZENGE in 1 BAG (12546-241-40)	40 lozenge	2019-01-25	0000-00-00	No	No	Current
12546-241-80	12546024180	80 LOZENGE in 1 BAG (12546-241-80)	80 lozenge	2019-01-25	0000-00-00	No	No	Current