Halls

Product NDC: 12546-110
Requested package NDC: 12546-110-01
11-digit product format: 125460110
Labeler code: 12546
Product ID: 12546-110_51b2efc4-6f46-16dc-e063-6294a90a509e
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: 2019-03-24
Substance: MENTHOL
Active strength: 7.5 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Honey Lemon
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	7.5 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
1250189	Internal RxNorm lookup
1250191	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
aec46410-ffb1-4db4-b232-82110c562f69	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12546-110-00	HallsHoney Lemon	250 in 1 JAR	LOZENGE	250	20
12546-110-01	HallsHoney Lemon	140 in 1 BAG	LOZENGE	140	20
12546-110-02	HallsHoney Lemon	150000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	LOZENGE	150000	20
12546-110-03	HallsHoney Lemon	2400 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	LOZENGE	2400	20
12546-110-04	HallsHoney Lemon	720 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	LOZENGE	720	20
12546-110-14	HallsHoney Lemon	14 in 1 PACKAGE	LOZENGE	14	20
12546-110-16	HallsHoney Lemon	16 in 1 BAG	LOZENGE	16	20
12546-110-18	HallsHoney Lemon	18 in 1 BAG	LOZENGE	18	20
12546-110-24	HallsHoney Lemon	24 in 1 BAG	LOZENGE	24	20
12546-110-30	HallsHoney Lemon	30 in 1 BAG	LOZENGE	30	20
12546-110-40	HallsHoney Lemon	40 in 1 BAG	LOZENGE	40	20
12546-110-80	HallsHoney Lemon	80 in 1 BAG	LOZENGE	80	20
12546-110-96	HallsHoney Lemon	96 in 1 BAG	LOZENGE	96	20
12546-110-99	HallsHoney Lemon	160 in 1 BAG	LOZENGE	160	20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3
BETA CAROTENE	INACTIVE INGREDIENT	01YAE03M7J	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12546-110	HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]	18	Current NDC, Legacy NDC, 14 package rows	20240622_aec46410-ffb1-4db4-b232-82110c562f69.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 28 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Childrens Cough	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	b8132c81-5291-431a-ad3a-ec8a3eb21c19	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Stuffy Nose and Chest Congestion	GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	7354f57c-0ecf-481f-9482-0040c90c4350	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	5bda415d-739f-4ca5-b5b2-07c14a81863b	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	8f3eb5c5-832e-4806-b3da-ef112cf55dcf	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Night Time Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDE	Reckitt Benckiser LLC	e3aea6df-37a4-43c5-a192-a902cbff3f92	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d9e5a8d7-814c-4ab1-bb05-e4cb9155978e	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack	ACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	Reckitt Benckiser LLC	c7ab5201-8550-4bf4-957c-c8f049aeaa4a	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	84e7be8f-2785-45ef-9c44-de05394fcd99	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	771d7fd8-184f-48a3-90ed-e8f00159d97e	2026-05-18	Warnings	Exact identifier application number: M012
MUCINEX Childrens Stuffy Nose	OXYMETAZOLINE HYDROCHLORIDE	Reckitt Benckiser LLC	de1c0abd-1644-4351-8106-e9df6ca5c142	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Fever Sore Throat and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	1538a75d-582a-9501-e063-6394a90a6c55	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Reckitt Benckiser LLC	14be3ab0-d6ae-e342-e063-6294a90ab851	2026-05-18	Warnings	Exact identifier application number: M012
Banophen	DIPHENHYDRAMINE HCL	Bryant Ranch Prepack	20f00537-2c8a-45d1-8e5f-ec276d0a47b6	2026-05-18	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	38df2308-f6f9-4476-ad34-4b5bc5f9fdf2	2026-05-18	Warnings	Exact identifier application number: M012
Allergy Plus Headache Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	WALMART INC.	88e3b969-79d0-4e64-95c0-c5cfd41e365f	2026-05-18	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	db264d2f-bf81-4da2-8595-2bfa1e4ba2f1	2026-05-18	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	b8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c	2026-05-15	Warnings	Exact identifier application number: M012
good neighbor pharmacy cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	da91e6b6-32ff-44fd-afce-33ea9549554b	2026-05-15	Warnings	Exact identifier application number: M012
Antihistamine	DIPHENHYDRAMINE HCL	Gendose Pharmaceuticals, LLC	847cdee8-410f-4ff3-9245-976ed6f4c776	2026-05-15	Warnings	Exact identifier application number: M012
Antihistamine	DIPHENHYDRAMINE HCL	Gendose Pharmaceuticals, LLC	d3b2f300-d919-44cd-ab71-b74b5bdfd977	2026-05-15	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1250191	Halls 7.5 MG Oral Lozenge	PSN	aec46410-ffb1-4db4-b232-82110c562f69	20
1250189	menthol 7.5 MG Oral Lozenge	PSN	aec46410-ffb1-4db4-b232-82110c562f69	20
1250191	menthol 7.5 MG Oral Lozenge [Halls]	SBD	aec46410-ffb1-4db4-b232-82110c562f69	20
1250189	menthol 7.5 MG Oral Lozenge	SCD	aec46410-ffb1-4db4-b232-82110c562f69	20
1250191	Halls 7.5 MG Oral Lozenge	SY	aec46410-ffb1-4db4-b232-82110c562f69	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
12546-110-01	12546011001	140 LOZENGE in 1 BAG (12546-110-01)	140 lozenge	2023-04-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HALLS HONEY LEMON bag	Mondelez Global LLC \| Mondelez Canada Inc.	2026-05-13	HUMAN OTC DRUG LABEL	20
Halls Variety Pack - Mentho-lyptus, Honey Lemon & Cherry	Mondelez Global LLC \| Mondelez Canada Inc.	2026-05-08	HUMAN OTC DRUG LABEL	1