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		2026-10-27
excluded package	package	12546-642	12546-642-30	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 · 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 137 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
daytime nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	4b49137c-8fc9-43b7-b1a1-82e318237eb6	2024-11-12	Warnings	Exact identifier application number: M012
CVS Original Nasal Mist	OXYMETAZOLINE HCL	CVS PHARMACY, INC	e9c551a0-cd78-4272-b42f-36c096d26736	2024-11-12	Warnings	Exact identifier application number: M012
up and up cough plus chest congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Target Corporation	ed5dfeb1-8f7a-46ff-ae27-3fa5de5b397c	2024-11-12	Warnings	Exact identifier application number: M012
DG Health Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	b33d104b-0b4d-40c6-8345-c2c740327331	2024-11-11	Warnings	Exact identifier application number: M012
Zephrex D	PSEUDOEPHEDRINE HYDROCHLORIDE	L. Perrigo Company	5468a7e2-361b-494f-9ca3-1b62f3819f65	2024-11-11	Warnings	Exact identifier application number: M012
careone tussin dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	American Sales Company	6c90fccf-0e6f-43df-9468-d8ece8ded009	2024-11-11	Warnings	Exact identifier application number: M012
good sense night time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	89dc1423-d097-47a8-9025-eab5381cca26	2024-11-11	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	10f9627b-edda-422a-b01f-7066f9c98335	2024-11-11	Warnings	Exact identifier application number: M012
nighttime severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	17c3fe42-3c40-4405-80b7-b3f9e4aa8376	2024-11-11	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	1dd36aa7-f085-4350-8cf2-f9fa29b583e4	2024-11-11	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	a7f9f1d0-7498-461c-b4e8-4c92cf3feae8	2024-11-11	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Walgreen Company	bd079f5d-0a38-40e6-9661-e8236c88a24d	2024-11-11	Warnings	Exact identifier application number: M012
GUAIFENESIN DM	GUAIFENESIN AND DEXTROMETHORPHAN	PAI Holdings, LLC dba PAI Pharma	ff970fff-d1a3-4322-83b4-34e361431a1c	2024-11-11	Warnings	Exact identifier application number: M012
topcare tussin dm max	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	e1118592-30ac-4505-9f38-c6d395c4cf5b	2024-11-11	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	624b8029-9fdb-4908-a13b-f9dd75030120	2024-11-11	Warnings	Exact identifier application number: M012
Biofreeze Colorless	MENTHOL	A-S Medication Solutions	cc1cba14-da40-4d7d-b522-b5c648798e96	2024-11-11	Warnings	Exact identifier application number: M012
foster and thrive nighttime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	298b7754-d0d8-496d-9949-4c346cb11e34	2024-11-11	Warnings	Exact identifier application number: M012
leader tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Cardinal Health 110, LLC. dba Leader	b418c10c-528b-4395-944e-af959b639ec2	2024-11-10	Warnings	Exact identifier application number: M012
equaline adult tussin	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	United Natural Foods, Inc. dba UNFI	f7c753f8-4b12-4797-a599-736d597bc1bc	2024-11-10	Warnings	Exact identifier application number: M012
foster and thrive adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Strategic Sourcing Services LLC	f8933226-fbc9-44e3-a90f-4e6c1dbdb7b7	2024-11-10	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