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 117 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY, INC	1b8d5494-1fcf-4cd0-acc0-34f17d577bd7	2025-03-14	Warnings	Exact identifier application number: M012
Ultra Concentrated Daytime COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	PuraCap Pharmaceutical LLC	300b2357-933b-fe9a-e063-6294a90aa4b9	2025-03-11	Warnings	Exact identifier application number: M012
Ultra Concentrated Nighttime COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	PuraCap Pharmaceutical LLC	300bf27f-744f-7366-e063-6394a90acbcb	2025-03-11	Warnings	Exact identifier application number: M012
Daytime COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	PuraCap Pharmaceutical LLC	300c7c7b-ea0b-3650-e063-6294a90a65e8	2025-03-11	Warnings	Exact identifier application number: M012
Rompe Pecho Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	EFFICIENT LABORATORIES INC	2ec319a8-92bf-4552-86dd-37cbce18980f	2025-03-11	Warnings	Exact identifier application number: M012
HISTEX-DM New Formulation	DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCI	Allegis Pharmaceuticals, LLC	30010401-e5b4-2bd9-e063-6394a90a0b0b	2025-03-10	Warnings	Exact identifier application number: M012
daytime severe cold multi-symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	cc7c5f1c-76b7-4278-8e2a-5fbc85e022dd	2025-03-08	Warnings	Exact identifier application number: M012
Cold and Head Congestion Relief Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	WinCo Foods, LLC	a39778ba-1f63-4495-8e9b-44b0bdd7f71a	2025-03-08	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat Day	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	2e9540e4-bd1d-9370-e063-6294a90affcb	2025-03-07	Warnings	Exact identifier application number: M012
Herbal Cough Drops Original Herb	COUGH DROPS	Topco Associates LLC	2fb22181-aee3-d0bf-e063-6294a90a7865	2025-03-06	Warnings	Exact identifier application number: M012
REVASOL DAYTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Rnv LLC	2f9ddcc3-b913-f8b0-e063-6294a90a93ab	2025-03-05	Warnings	Exact identifier application number: M012
Herbal Throat Drops Lemon Mint Herb	THROAT DROPS	Topco Associates LLC	2fa086b4-3b0e-0df8-e063-6294a90a6769	2025-03-05	Warnings	Exact identifier application number: M012
Redicare Nasal and Sinus Decongestant	REDICARE NASAL AND SINUS DECONGESTANT	Redicare LLC	2f24be68-f30e-d916-e063-6294a90a7e31	2025-03-04	Warnings	Exact identifier application number: M012
Diphenhydramine HCl Oral Solution	DIPHENHYDRAMINE HCL ORAL SOLUTION	Kesin Pharma Corporation	2f871005-de4d-8b2a-e063-6394a90aa43a	2025-03-04	Warnings	Exact identifier application number: M012
CVS Daytime Cough Relief Chews - Citrus Punch	DEXTROMETHORPHAN HBR	CVS	2f885f1b-7ff5-251b-e063-6394a90a656f	2025-03-04	Warnings	Exact identifier application number: M012
CVS Dex-Dox Kids Nighttime Cough Suppressant	DEXTROMETHORPHAN HBR	CVS	2f8b6f5e-399c-b033-e063-6294a90ac3d1	2025-03-04	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Pioneer Life Sciences, LLC	ff8b096c-8f01-4a8c-a98f-e4aa4d688e95	2025-03-04	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Vanilla Flavor	MENTHOL	7-ELEVEN	2f3c43dd-175f-722e-e063-6294a90acff9	2025-02-28	Warnings	Exact identifier application number: M012
Menthol Cough Drops Creamy Strawberry Flavor	MENTHOL AND PECTIN	7-ELEVEN	2f3c3c65-4178-6304-e063-6294a90a51fa	2025-02-28	Warnings	Exact identifier application number: M012
Menthol Cough Drops Creamy Strawberry Flavor	MENTHOL AND PECTIN	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2efbffd7-bbdd-c5f5-e063-6294a90a15f0	2025-02-25	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