Halls

Product NDC: 12546-642
11-digit product format: 125460642
Labeler code: 12546
Product ID: 12546-642_407f2207-a647-78ee-e063-6394a90add7e
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: 2019-05-27
Substance: MENTHOL
Active strength: 7.6 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	12546-642	12546-642-02	D	Discontinued by firm		2026-10-20
excluded package	package	12546-642	12546-642-30	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 · 35 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	12546-642-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	12546-642-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-642-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-642-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-642-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-642-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-642-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-642-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-642-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-642-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-642-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-642-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-642-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-642-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-642-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-642-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-642-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-642-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-642-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-642-25	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-642-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-642-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-642-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-642-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-642-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-642-25	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-642-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-642-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-642-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-642-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-642-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-642-25	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-642-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-642-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-642-25	`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: Sugar Free Honey Lemon
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	7.6 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
359751	Internal RxNorm lookup
897006	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
2b19fdd2-8088-47f2-be20-f220a6b825fc	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12546-642-02	HallsSugar Free Honey Lemon	2 in 1 BAG	LOZENGE	2	10
12546-642-25	HallsSugar Free Honey Lemon	25 in 1 BAG	LOZENGE	25	10
12546-642-30	HallsSugar Free Honey Lemon	30 in 1 BAG	LOZENGE	30	10
12546-642-70	HallsSugar Free Honey Lemon	70 in 1 BAG	LOZENGE	70	10
12546-642-79	HallsSugar Free Honey Lemon	180 in 1 BAG	LOZENGE	180	10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
BETA CAROTENE	INACTIVE INGREDIENT	01YAE03M7J	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
ISOMALT	INACTIVE INGREDIENT	S870P55O2W	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12546-642	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	9	Current NDC, Legacy NDC, 5 package rows	20240622_2b19fdd2-8088-47f2-be20-f220a6b825fc.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 63 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zicam Extreme Congestion Relief	OXYMETAZOLINE HYDROCHLORIDE	Church & Dwight Co., Inc.	ccada339-656c-a461-e053-2a95a90a3479	2025-12-31	Warnings	Exact identifier application number: M012
ED A-HIST DM	DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	EDWARDS PHARMACEUTICALS, INC.	e0e2b117-62bc-4132-9f7c-fe2a912052b1	2025-12-31	Warnings	Exact identifier application number: M012
Bio-Z-Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Advanced Generic Corporation	05e70eab-1467-4b09-991e-ef03f222e021	2025-12-31	Warnings	Exact identifier application number: M012
Altipres-B	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Alternative Pharmacal Corporation	fd00c41d-0580-4177-afaa-60bb12ca5a09	2025-12-31	Warnings	Exact identifier application number: M012
Ninjacof-D	CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	Centurion Labs, LLC	5188aa20-41f1-4998-81e1-f4de055874bc	2025-12-31	Warnings	Exact identifier application number: M012
Llorens Care Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	4743e562-1217-50ab-e063-6394a90af88d	2025-12-31	Warnings	Exact identifier application number: M012
Llorens Care Tussin	GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	474459c1-bfd7-dec7-e063-6394a90ac18d	2025-12-31	Warnings	Exact identifier application number: M012
Geri Care Tussin CF Max	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN	GERI-CARE PHARMACEUTICAL CORP	4744669c-7f33-e35f-e063-6394a90a79b7	2025-12-31	Warnings	Exact identifier application number: M012
Geri-Tussin	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	65545ca3-4e93-4b59-9e17-4742e086e8e7	2025-12-31	Warnings	Exact identifier application number: M012
GeriCare Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	GERI-CARE PHARMACEUTICALS, CORP	47451cd8-7aab-90e2-e063-6394a90ad1b7	2025-12-31	Warnings	Exact identifier application number: M012
Curewell Tussin	GUAIFENESIN	RMT HEALTH LLC	47455587-5074-e70d-e063-6294a90a78bb	2025-12-31	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Bestco Inc.	77e25027-3c96-21fa-e053-2991aa0a1f31	2025-12-31	Warnings	Exact identifier application number: M012
Puregen Labs Allergy Relief	DIPHENHYDRAMINE HCL	Advanced Rx LLC	4745d4f9-bbdf-a4a6-e063-6294a90a15b2	2025-12-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	2a46ea9b-29e9-5197-e063-6394a90abc73	2025-12-31	Warnings	Exact identifier application number: M012
Cherry Cough Drops	MENTHOL	Bestco Inc.	77e50410-306d-b2fb-e053-2a91aa0af3c5	2025-12-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	e086a6d2-f664-454e-9524-f656bfbf45df	2025-12-31	Warnings	Exact identifier application number: M012
Cherry Cough Drops	MENTHOL	Bestco Inc.	77f45efb-8ee0-1186-e053-2991aa0a9884	2025-12-31	Warnings	Exact identifier application number: M012
Conex Pediatric	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	2a46af43-ef36-e14e-e063-6394a90a8285	2025-12-31	Warnings	Exact identifier application number: M012
Conex	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	2a343656-ac6d-8b20-e063-6294a90ab319	2025-12-31	Warnings	Exact identifier application number: M012
Dologesic NF	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	Llorens Pharmaceutical International Division	974fc0d5-7a99-46fb-af38-b91240f728fa	2025-12-31	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
897006	Halls 7.6 MG Oral Lozenge	PSN	2b19fdd2-8088-47f2-be20-f220a6b825fc	10
359751	menthol 7.6 MG Oral Lozenge	PSN	2b19fdd2-8088-47f2-be20-f220a6b825fc	10
897006	menthol 7.6 MG Oral Lozenge [Halls]	SBD	2b19fdd2-8088-47f2-be20-f220a6b825fc	10
359751	menthol 7.6 MG Oral Lozenge	SCD	2b19fdd2-8088-47f2-be20-f220a6b825fc	10
897006	Halls 7.6 MG Oral Lozenge	SY	2b19fdd2-8088-47f2-be20-f220a6b825fc	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12546-642-02	12546064202	2 LOZENGE in 1 BAG (12546-642-02)	2 lozenge	2019-05-27	0000-00-00	No	No	Current
12546-642-25	12546064225	25 LOZENGE in 1 BAG (12546-642-25)	25 lozenge	2019-05-27	0000-00-00	No	No	Current
12546-642-30	12546064230	30 LOZENGE in 1 BAG (12546-642-30)	30 lozenge	2019-05-27	0000-00-00	No	No	Current
12546-642-70	12546064270	70 LOZENGE in 1 BAG (12546-642-70)	70 lozenge	2019-05-27	0000-00-00	No	No	Current
12546-642-79	12546064279	180 LOZENGE in 1 BAG (12546-642-79)	180 lozenge	2019-05-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Halls SF honey lemon bag	Mondelez Global LLC \| Mondelez Canada Inc.	2025-10-06	HUMAN OTC DRUG LABEL	10