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		2026-10-15
excluded package	package	12546-642	12546-642-30	D	Discontinued by firm		2026-10-15

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 6 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HyVee Daytime Severe Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	HyVee Inc	496ec389-1aea-f202-e063-6394a90ae51c	2026-08-20	Warnings	Exact identifier application number: M012
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACK	BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	4d94968b-ada3-4344-8563-cba7fc491d74	2026-08-19	Warnings	Exact identifier application number: M012
CVS Adult Mucus chest congestion	GUAIFENESIN	CVS PHARMACY	bec04049-03b2-4465-9cf5-0ad2ef8014ef	2026-08-19	Warnings	Exact identifier application number: M012
CVS Childrens Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	CVS PHARMACY, INC	fe12f3bd-3237-42d1-aec5-c831b9637175	2026-08-19	Warnings	Exact identifier application number: M012
CVS Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY, INC	bfb3d021-f65f-499c-bbb1-c1aceb7a7bf9	2026-08-19	Warnings	Exact identifier application number: M012
CVS Long Acting Cough	DEXTROMETHORPHAN HBR	CVS PHARMACY, INC	31a7c0e2-af1c-45dd-8a93-e0879cae6005	2026-08-19	Warnings	Exact identifier application number: M012
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	b3baf939-a9fd-47ac-9bc7-68435e32ea1e	2026-08-19	Warnings	Exact identifier application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CVS PHARMACY	5151127a-4d09-413a-a08b-f76fb77e1188	2026-08-19	Warnings	Exact identifier application number: M012
CVS DT and NT Combo Pack Cold and Flu	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	CVS PHARMACY	360c8c62-0945-4031-b291-d40c4270b940	2026-08-19	Warnings	Exact identifier application number: M012
equate childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	WALMART INC.	24758ab0-ba08-4b4a-9861-449612bdb89c	2026-08-19	Warnings	Exact identifier application number: M012
CVS Adult Mucus plus Chest Congestion	GUAIFENESIN	CVS PHARMACY	3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a	2026-08-19	Warnings	Exact identifier application number: M012
CVS Childrens Cold plus Cough plus Runny Nose	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	CVS	7dc30e46-e289-40fc-b217-b123fee5daee	2026-08-19	Warnings	Exact identifier application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	CVS PHARMACY	4490a7e1-d5b9-459c-8751-c24486807981	2026-08-19	Warnings	Exact identifier application number: M012
CVS DayTime and NightTime Value Pack Cold and Flu	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	CVS PHARMACY	4c813cd5-2c97-4fc3-926c-1a0396551a31	2026-08-19	Warnings	Exact identifier application number: M012
CVS Adult Cough plus Chest Congestion DM Max with Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS PHARMACY	822d5bf6-8841-4b7f-bbf7-90c3d50b8024	2026-08-19	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	2517b241-c433-440f-999d-5a32d5bbaa26	2026-08-19	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cough and Chest Congestion Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	CVS Pharmacy	347f1731-5b85-4220-ae2b-9497a3afa4ed	2026-08-19	Warnings	Exact identifier application number: M012
CVS Maximum Strength Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL	CVS PHARMACY	e1c246a4-7a8c-4761-ab26-13b5165029cc	2026-08-19	Warnings	Exact identifier application number: M012
CVS childrens Cough and Cold	CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR	CVS PHARMACY	035c5e2a-04e3-490b-8f1a-233a5cb6eadb	2026-08-19	Warnings	Exact identifier application number: M012
rugby cough syrup	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Rugby Laboratories	89752c69-25c8-45e3-9021-f81b35b52d36	2026-08-19	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