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		2026-10-20

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	12546-241-40	`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 55 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief Extra Strength	DIPHENHYDRAMINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	4f33c1fb-150b-4083-a9a4-c0fbab4b6133	2026-01-27	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution Inc	5ca7dc60-af0c-47c6-b453-8b39c744eb5b	2026-01-27	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	HyVee Inc	2ce5f2af-cabc-466f-b0c5-256e6e6d4c88	2026-01-27	Warnings	Exact identifier application number: M012
Sinus Headache and Pain Day, Non-drowsy	ACETAMINOPHEN, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	c33340c0-47d3-45e2-997b-3d9fb148900f	2026-01-27	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	L.N.K. International, Inc.	b7501b59-d25a-49ec-9cbf-47018bce8397	2026-01-27	Warnings	Exact identifier application number: M012
good sense nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L. Perrigo Company	f90bd64a-dd1a-4319-87cd-427d57f677ab	2026-01-26	Warnings	Exact identifier application number: M012
Equate Health Non Drowsy DAY Cold and Flu Plus and NIGHTTIME Cold and Flu Plus	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	547ff880-3d40-4a4a-84ee-cd0d5290a9b9	2026-01-26	Warnings	Exact identifier application number: M012
Maximum Strength Non Drowsy Day and Night Cold and Flu	MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLU	WAL-MART STORES INC	d6a35fb8-1899-4da2-ad2b-0423e332845d	2026-01-26	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	Prodose, Inc.	7e5de5b0-18f0-4807-8686-da9821f918ce	2026-01-26	Warnings	Exact identifier application number: M012
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	Wal-Mart Stores Inc	b9fbf917-12b7-770f-e053-2995a90afe93	2026-01-26	Warnings	Exact identifier application number: M012
Maximum Strength Non Drowsy Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	b58b2c36-a403-4dae-b3b2-f0ffd28a963b	2026-01-26	Warnings	Exact identifier application number: M012
Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	870e6bcb-84ab-45e0-ae57-08a9a182eb0b	2026-01-26	Warnings	Exact identifier application number: M012
Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	eb8e83a4-981b-48a5-88f4-3a0ba358d3bc	2026-01-26	Warnings	Exact identifier application number: M012
NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	8d2d765f-a7e3-40e6-b35d-0e8806a7ea59	2026-01-26	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU CHERRY	PHENYLEPHRINE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE	Walgreen Company	02a6781c-aa6f-8fb0-e063-6294a90a043d	2026-01-26	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATE	Walgreen Company	02e5f475-4e9f-2856-e063-6294a90a21fd	2026-01-26	Warnings	Exact identifier application number: M012
GNP Vapor Steam camphor (synthetic)	CAMPHOR (SYNTHETIC)	AmerisourceBergen	0bcc55bf-9654-120b-e063-6394a90a59d1	2026-01-26	Warnings	Exact identifier application number: M012
S2	RACEPINEPHRINE HYDROCHLORIDE	Nephron Pharmaceuticals Corporation	dd1b35c7-b23b-4b95-8162-df3d263fe32e	2026-01-26	Warnings	Exact identifier application number: M012
SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0d97c634-0975-42d5-8ade-2ed2018cfe9d	2026-01-26	Warnings	Exact identifier application number: M012
GOOD SENSE NIGHT TIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	L. Perrigo Company	cd68289b-3850-40c6-9439-aae0e2d7637d	2026-01-26	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