Halls

Product NDC: 12546-347
11-digit product format: 125460347
Labeler code: 12546
Product ID: 12546-347_2d67d823-08cc-57cc-e063-6394a90a1ce5
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: 2020-10-21
Substance: MENTHOL
Active strength: 2.5 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	12546-347	12546-347-03	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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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	2.5 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
616344	Internal RxNorm lookup
896992	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
5d56ccd2-1c28-4750-9454-44809091ad2f	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12546-347-03	HallsSugar Free Honey Lemon	11667 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	LOZENGE	11667	14
12546-347-24	HallsSugar Free Honey Lemon	24 in 1 PACKAGE	LOZENGE	24	14
12546-347-48	HallsSugar Free Honey Lemon	2 in 1 BAG	LOZENGE	2	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12546-347	HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	14	Current NDC, Legacy NDC, 3 package rows	20250223_5d56ccd2-1c28-4750-9454-44809091ad2f.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 170 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Antihistamine	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	af5053d8-ba02-4cdf-877f-8c1e368dafe0	2024-01-10	Warnings	Exact identifier application number: M012
HISTEX	TRIPROLIDINE HYDROCHLORIDE	Allegis Pharmaceuticals, LLC	cc466d33-cf3e-4f1c-a794-6d3d79903adf	2024-01-08	Warnings	Exact identifier application number: M012
HISTEX-DM	DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Allegis Pharmaceuticals, LLC	836d062c-29f0-4fd7-b65c-771a3bbd52c4	2024-01-08	Warnings	Exact identifier application number: M012
Banophen	DIPHENHYDRAMINE HCL	A-S Medication Solutions	e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd	2024-01-08	Warnings	Exact identifier application number: M012
AXIM DM Max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	VIVUNT PHARMA LLC	0e7424ea-461f-5ead-e063-6294a90a41b6	2024-01-05	Warnings	Exact identifier application number: M012
AXIM Night Time - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	0e740063-80d5-c48b-e063-6394a90a3b30	2024-01-05	Warnings	Exact identifier application number: M012
AXIM DayTime - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	VIVUNT PHARMA LLC	0e742e10-daea-6443-e063-6294a90ab5af	2024-01-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	3c3e0dc8-cddd-4f46-9b68-19bac00c07cc	2024-01-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	A-S Medication Solutions	fa12a5a8-bf2d-4991-9d54-9c519e8e04cd	2024-01-04	Warnings	Exact identifier application number: M012
NASAL DECONGESTANT PE 10mg	PHENYLPHRINE HCL	YYBA CORP	05824fc4-ef3f-4ebb-b601-252f76ad60ef	2024-01-03	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Proficient Rx LP	5943d975-77e4-4cbd-b2d9-d699052fe82a	2024-01-01	Warnings	Exact identifier application number: M012
Coricidin HBP Cold and Flu	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	Proficient Rx LP	ac79a7dd-c26e-47d2-8fb9-768d2d09e507	2024-01-01	Warnings	Exact identifier application number: M012
Oxymethazoline HCL	OXYMETHAZOLINE HCL	Proficient Rx LP	96883e5f-18b5-4c1c-b984-756cb86be6ff	2024-01-01	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Proficient Rx LP	6e91b9c3-57e8-488b-ac70-d863cdf9d6e8	2024-01-01	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Proficient Rx LP	9e067482-8735-4476-a82e-438dd24d4289	2024-01-01	Warnings	Exact identifier application number: M012
XL-3 Day Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	AptaPharma Inc.	94e02be4-b8a6-422a-8f66-e6a69e924b2c	2023-12-30	Warnings	Exact identifier application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM	DEXTROMETHORPHAN HYDROBROMIDE	AptaPharma Inc.	8a4c55d0-c472-4e89-9fdb-17ecf0af4856	2023-12-30	Warnings	Exact identifier application number: M012
XL-3 Xtreme	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	AptaPharma Inc.	dff79e0b-edf0-4dd3-a722-fd9beecd6293	2023-12-30	Warnings	Exact identifier application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Salado Sales, Inc.	e25727d0-7dd7-4ef5-b064-7938679f075f	2023-12-29	Warnings	Exact identifier application number: M012
Maximum Strength DM MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	H E B	bb56d09d-ecb0-469e-a16f-f9f1a48942a8	2023-12-29	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
896992	Halls 2.5 MG Oral Lozenge	PSN	5d56ccd2-1c28-4750-9454-44809091ad2f	14
616344	menthol 2.5 MG Oral Lozenge	PSN	5d56ccd2-1c28-4750-9454-44809091ad2f	14
896992	menthol 2.5 MG Oral Lozenge [Halls]	SBD	5d56ccd2-1c28-4750-9454-44809091ad2f	14
616344	menthol 2.5 MG Oral Lozenge	SCD	5d56ccd2-1c28-4750-9454-44809091ad2f	14
896992	Halls 2.5 MG Oral Lozenge	SY	5d56ccd2-1c28-4750-9454-44809091ad2f	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12546-347-03	12546034703	11667 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-347-03)	11667 lozenge	2020-10-21	0000-00-00	No	No	Current
12546-347-24	12546034724	24 LOZENGE in 1 PACKAGE (12546-347-24)	24 lozenge	2020-10-21	0000-00-00	No	No	Current
12546-347-48	12546034748	2 PACKAGE in 1 BAG (12546-347-48) / 24 LOZENGE in 1 PACKAGE (12546-347-24)	2 package	2025-06-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Halls Minis sugar free honey lemon 24ct	Mondelez Global LLC \| MSI Express Inc \| Mondelez Canada Inc	2025-02-05	HUMAN OTC DRUG LABEL	14