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 26 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Dye Free Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	74ff4f0d-7952-4b74-b1b2-5a2beab91f7c	2026-05-22	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	WALMART INC.	321430a5-11c9-4d33-8638-5149f601f1bb	2026-05-22	Warnings	Exact identifier application number: M012
dg health cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Dolgencorp Inc	ddcc1e78-4ea8-4489-88e7-86ff46016464	2026-05-21	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY DAYTIME FLU RELIEF MAX STRENGTH	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	AMERISOURCE BERGEN	45dc9dd7-134a-4e70-a07e-7bfdf0dc1c4e	2026-05-21	Warnings	Exact identifier application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Kenvue Brands LLC	525467fb-510d-0b4b-e063-6294a90acd36	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	Reckitt Benckiser LLC	4cee80e5-e412-e832-e063-6394a90aeb90	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Reckitt Benckiser LLC	4a9464cf-0c77-23d0-e063-6394a90a62f1	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens Night Time Multi-Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	Reckitt Benckiser LLC	4ceda68e-c7ce-eb87-e063-6394a90a8ded	2026-05-21	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Day Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	5258ea3f-87f1-7f86-e063-6394a90ab82f	2026-05-21	Warnings	Exact identifier application number: M012
RELIABLE-1 ANTI DRIP PUMP MIST	OXYMETAZOLINE HYDROCHLORIDE	Reliable 1 Laboratories LLC	7df9905d-09aa-4c84-8b6f-6e5ed90df0da	2026-05-21	Warnings	Exact identifier application number: M012
daytime nitetime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Publix Super Markets Inc	80abb6b8-b0d5-4f19-8588-50b8717510bb	2026-05-21	Warnings	Exact identifier application number: M012
FAMILY DOLLAR ULTRA FINE MIST SINUS RELIEF	OXYMETAZOLINE HYDROCHLORIDE	FAMILY DOLLAR SERVICES INC	27163169-54d0-4b6e-94cd-721b29b18249	2026-05-20	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Cough Fast	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	5241b11a-72c8-5e67-e063-6394a90a4353	2026-05-20	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	50b140ad-aba2-ce6b-e063-6294a90ae2f8	2026-05-20	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Recharge Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	4bae240c-70ce-e9c2-e063-6394a90a5f3d	2026-05-20	Warnings	Exact identifier application number: M012
Childrens Mucinex Multi Symptom Cold and Childrens Mucinex Night Time Multi Symptom Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	85f7d60b-32ec-4ec2-86ec-f677093bce1d	2026-05-20	Warnings	Exact identifier application number: M012
Chloraseptic Nighttime Sore Throat Hot Relief	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Prestige Brands Holdings, Inc.	9c13c052-a5d1-43d2-8d29-4ea011a971ac	2026-05-20	Warnings	Exact identifier application number: M012
Cold and Flu Severe, Daytime, Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	a0bff310-2d35-4a18-815b-8386e44730a2	2026-05-19	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	61a1beb3-decf-4c8d-a402-93a02ec40a43	2026-05-19	Warnings	Exact identifier application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	52291746-2bbf-8f3f-e063-6294a90adcfc	2026-05-19	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