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		2026-10-28

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 121 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
UP AND UP NO DRIP NASAL	OXYMETAZOLINE HYDROCHLORIDE	Target Corporation	760d6d0f-00fc-40bc-858d-83a0827d139f	2025-01-29	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan	GUAIFENESIN AND DEXTROMETHORPHAN	Major Pharmaceuticals	51e48201-bb62-4e89-85eb-e4a416f93522	2025-01-29	Warnings	Exact identifier application number: M012
Severe Congestion and Cough Max	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Best Choice	8c878e47-94f4-484f-bdd8-6d87ac2440d8	2025-01-28	Warnings	Exact identifier application number: M012
Cough and Cold Therapy	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Everlaan Organics Inc	088be461-7afc-586a-e063-6294a90a700b	2025-01-27	Warnings	Exact identifier application number: M012
Cough and Cold Therapy For Kids	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Everlaan Organics Inc	088df369-114c-db4f-e063-6394a90acfac	2025-01-27	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Target Corporation Inc.	eb4c2c3f-91d7-e4c6-e053-2a95a90a4e8a	2025-01-26	Warnings	Exact identifier application number: M012
Walgreens Menthol Cough Drops	MENTHOL	Walgreens	2c62f690-8dfb-d28e-e063-6394a90a45a2	2025-01-23	Warnings	Exact identifier application number: M012
Walgreens Cherry Cough Drops	MENTHOL	Walgreens	2c65d836-e724-50d6-e063-6394a90a0827	2025-01-23	Warnings	Exact identifier application number: M012
Walgreens Honey Lemon Cough Drops	MENTHOL	Walgreens	2c67424c-2fb0-cc15-e063-6394a90a02ca	2025-01-23	Warnings	Exact identifier application number: M012
Pharmacys Prescription Analgesic Gel	MENTHOL	American Consumer Products Corp	6f0725f2-833f-f3a0-e053-2a91aa0a3911	2025-01-23	Warnings	Exact identifier application number: M012
Pharmacys Prescription Vapor Rub	MENTHOL	American Consumer Products Corp	6ef328ff-f5c3-515d-e053-2a91aa0a32d3	2025-01-23	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Best Choice	0035e6a4-b3ef-4e0b-aa7f-7453dd065f4d	2025-01-22	Warnings	Exact identifier application number: M012
GOOD REMEDIES Allergy Relief SOFTGEL	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	26a02737-2cfd-769f-e063-6394a90af352	2025-01-22	Warnings	Exact identifier application number: M012
Pharbechlor	CHLORPHENIRAMINE MALEATE 4MG	Ulai Health LLC	6a1a5cef-e946-4ba8-9402-557c6adf45f9	2025-01-20	Warnings	Exact identifier application number: M012
Pharbinex	GUAIFENESIN 400MG	Ulai Health LLC	4eafa81a-aeee-4c97-85d6-594902b10919	2025-01-20		Exact identifier application number: M012
Pharbinex-PE	GUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MG	Ulai Health LLC	e459bb83-b1d6-42fc-aa46-99ad117e6144	2025-01-20		Exact identifier application number: M012
Pharbinex-DM	GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG	Ulai Health LLC	af80d10e-3fb2-405a-a803-1f876b8dcd10	2025-01-20		Exact identifier application number: M012
Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Bayer HealthCare LLC.	34b2e77f-5d04-15a7-e054-00144ff8d46c	2025-01-17	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	a23a6db6-4585-2882-e053-2a95a90ab01a	2025-01-17	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold Night PowerFast Fizz	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	fc754dff-cecd-fc6b-e053-6394a90ab371	2025-01-17	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