Halls

Product NDC: 12546-112
11-digit product format: 125460112
Labeler code: 12546
Product ID: 12546-112_29a54d04-41f2-c4b7-e063-6294a90aaed7
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: 2019-04-07
Substance: MENTHOL
Active strength: 5.4 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	12546-112	12546-112-14	D	Discontinued by firm	2026-10-23
excluded package	package	12546-112	12546-112-40	D	Discontinued by firm	2026-10-23
excluded package	package	12546-112	12546-112-96	D	Discontinued by firm	2026-10-23

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 · 36 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	12546-112-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	12546-112-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	12546-112-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-112-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-112-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	12546-112-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-112-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-112-96	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	12546-112-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-112-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-112-96	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	12546-112-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-112-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-112-96	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	12546-112-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-112-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-112-96	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	12546-112-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-112-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-112-96	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	12546-112-40	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-112-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-112-96	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	12546-112-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-112-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-112-96	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	12546-112-40	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-112-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-112-96	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	12546-112-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-112-40	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-112-96	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	12546-112-14	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-112-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-112-96	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	12546-112-14	`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: MENTHO-LYPTUS
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	5.4 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
485287	Internal RxNorm lookup
1250187	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
ff21cf0e-9811-4819-bdfc-17a950e9b114	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12546-112-14	HallsMENTHO-LYPTUS	14 in 1 BAG	LOZENGE	14	10
12546-112-30	HallsMENTHO-LYPTUS	30 in 1 BAG	LOZENGE	30	10
12546-112-40	HallsMENTHO-LYPTUS	40 in 1 BAG	LOZENGE	40	10
12546-112-80	HallsMENTHO-LYPTUS	80 in 1 BAG	LOZENGE	80	10
12546-112-89	HallsMENTHO-LYPTUS	200 in 1 BAG	LOZENGE	200	10
12546-112-96	HallsMENTHO-LYPTUS	96 in 1 BAG	LOZENGE	96	10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12546-112	HALLS MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	10	Current NDC, Legacy NDC, 6 package rows	20241222_ff21cf0e-9811-4819-bdfc-17a950e9b114.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 135 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextromethorphan HBr 15 mg	DEXTROMETHORPHAN HBR	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	028b025e-2dde-4bef-ba7b-61774e855b4b	2024-11-21	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	PuraCap Pharmaceutical LLC	856cb3c3-8f32-4285-8c13-25f01779a31a	2024-11-21	Warnings	Exact identifier application number: M012
Night Time Severe Cold and Flu Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE	PuraCap Pharmaceutical LLC	3375a059-2939-438e-92b5-a7f1952bbb22	2024-11-21	Warnings	Exact identifier application number: M012
NiteTime Cold/Flu, Multi-Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	9033bf94-f444-4488-b717-050d04dee388	2024-11-21	Warnings	Exact identifier application number: M012
Day and Night Sinus Relief Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	4b554ce8-9a6a-444f-b5ea-63359bbc0653	2024-11-21	Warnings	Exact identifier application number: M012
Day Severe Cold and Night Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	7492b381-9eca-4b07-b356-63fdaea14f81	2024-11-21	Warnings	Exact identifier application number: M012
Severe sinus Congestion Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	e173bec9-14df-4535-a023-47d8cda8d4ec	2024-11-21	Warnings	Exact identifier application number: M012
COLD FLU and SORE THROAT RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	1161e5dc-0677-4fb9-964f-971a508098b6	2024-11-21	Warnings	Exact identifier application number: M012
Night Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Retail Business Services, LLC	fc8c70d6-6be5-4f12-84b0-125fc82149ec	2024-11-21	Warnings	Exact identifier application number: M012
12 Hour Original Nasal Decongestant	NASAL SPRAY	WinCo Foods LLC	b3b6065a-56da-45e9-b89d-f6553bc181c9	2024-11-21	Warnings	Exact identifier application number: M012
Family Wellness Oxymetazoline Sinus Severe	OXYMETAZOLINE	FAMILY DOLLAR (Family Wellness)	13237d31-c60a-49f8-9b96-4414cf766a08	2024-11-21	Warnings	Exact identifier application number: M012
DayTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	5b55d1df-275b-40d8-bde3-fc43313b7eb3	2024-11-20	Warnings	Exact identifier application number: M012
Halls Green Apple	MENTHOL	Mondelez Global LLC	1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2	2024-11-20	Warnings	Exact identifier application number: M012
Halls Blueberry	MENTHOL	Mondelez Global LLC	275a6935-ea44-486e-e063-6394a90ae19a	2024-11-20	Warnings	Exact identifier application number: M012
No Drip Nasal Mist	OXYMETAZOLINE SPRAY	Walgreens Company	234bd567-4e3c-419f-a000-fdfc28cafc8b	2024-11-20	Warnings	Exact identifier application number: M012
NICE Assorted Cough Drops	MENTHOL	Leosons Overseas Corp	96db0f37-41cc-1ebd-e053-2a95a90a3215	2024-11-19	Warnings	Exact identifier application number: M012
Nice Cherry Cough Drops	MENTHOL	Leosons Overseas Corp	98e52604-6e41-6408-e053-2995a90a6bc8	2024-11-19	Warnings	Exact identifier application number: M012
NICE Citrus Cough Drops	MENTHOL	Leosons Overseas Corp	96d9527d-9bf9-ce82-e053-2995a90aff0c	2024-11-19	Warnings	Exact identifier application number: M012
NICE Menthol Cough Drops	MENTHOL	Leosons Overseas Corp	96d77897-475c-482c-e053-2995a90a2da4	2024-11-19	Warnings	Exact identifier application number: M012
NICE Honey Lemon Cough Drops	MENTHOL	Leosons Overseas Corp	96da2c9d-2d0d-6252-e053-2995a90ac338	2024-11-19	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1250187	Halls 5.4 MG Oral Lozenge	PSN	ff21cf0e-9811-4819-bdfc-17a950e9b114	10
485287	menthol 5.4 MG Oral Lozenge	PSN	ff21cf0e-9811-4819-bdfc-17a950e9b114	10
1250187	menthol 5.4 MG Oral Lozenge [Halls]	SBD	ff21cf0e-9811-4819-bdfc-17a950e9b114	10
485287	menthol 5.4 MG Oral Lozenge	SCD	ff21cf0e-9811-4819-bdfc-17a950e9b114	10
1250187	Halls 5.4 MG Oral Lozenge	SY	ff21cf0e-9811-4819-bdfc-17a950e9b114	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12546-112-14	12546011214	14 LOZENGE in 1 BAG (12546-112-14)	14 lozenge	2020-09-01	0000-00-00	No	No	Current
12546-112-30	12546011230	30 LOZENGE in 1 BAG (12546-112-30)	30 lozenge	2019-04-07	0000-00-00	No	No	Current
12546-112-40	12546011240	40 LOZENGE in 1 BAG (12546-112-40)	40 lozenge	2019-04-07	0000-00-00	No	No	Current
12546-112-80	12546011280	80 LOZENGE in 1 BAG (12546-112-80)	80 lozenge	2019-04-07	0000-00-00	No	No	Current
12546-112-89	12546011289	200 LOZENGE in 1 BAG (12546-112-89)	200 lozenge	2019-04-07	0000-00-00	No	No	Current
12546-112-96	12546011296	96 LOZENGE in 1 BAG (12546-112-96)	96 lozenge	2019-04-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Halls mentholyptus bag	Mondelez Global LLC \| Mondelez Canada Inc.	2024-12-19	HUMAN OTC DRUG LABEL	10