FDA.reportPublic FDA data

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
IngredientStrength
MENTHOL7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1250189Internal RxNorm lookup
1250191Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aec46410-ffb1-4db4-b232-82110c562f69Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-110-00HallsHoney Lemon250 in 1 JARLOZENGE25020
12546-110-01HallsHoney Lemon140 in 1 BAGLOZENGE14020
12546-110-02HallsHoney Lemon150000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLOZENGE15000020
12546-110-03HallsHoney Lemon2400 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLOZENGE240020
12546-110-04HallsHoney Lemon720 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLOZENGE72020
12546-110-14HallsHoney Lemon14 in 1 PACKAGELOZENGE1420
12546-110-16HallsHoney Lemon16 in 1 BAGLOZENGE1620
12546-110-18HallsHoney Lemon18 in 1 BAGLOZENGE1820
12546-110-24HallsHoney Lemon24 in 1 BAGLOZENGE2420
12546-110-30HallsHoney Lemon30 in 1 BAGLOZENGE3020
12546-110-40HallsHoney Lemon40 in 1 BAGLOZENGE4020
12546-110-80HallsHoney Lemon80 in 1 BAGLOZENGE8020
12546-110-96HallsHoney Lemon96 in 1 BAGLOZENGE9620
12546-110-99HallsHoney Lemon160 in 1 BAGLOZENGE16020

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AHALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]3
MENTHOLACTIVE MOIETYL7T10EIP3AHALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]3
BETA CAROTENEINACTIVE INGREDIENT01YAE03M7JHALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]3
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]3
HONEYINACTIVE INGREDIENTY9H1V576FHHALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]3
SUCROSEINACTIVE INGREDIENTC151H8M554HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RHALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-110HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]18Current NDC, Legacy NDC, 14 package rows20240622_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 20 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLC319e84fd-4033-f5eb-e063-6394a90aa2f32026-06-27WarningsExact identifier
application number: M012
HyVee Cough Drops MentholMENTHOLHY-VEE, INC47a6f3c3-a6fa-dd61-e063-6394a90a49652026-06-26WarningsExact identifier
application number: M012
HyVee Cough Drops CherryMENTHOLHY-VEE, INC47a717e9-56b3-e771-e063-6394a90a5c172026-06-26WarningsExact identifier
application number: M012
Calmco Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC5532fd37-cdd6-97ab-e063-6394a90a3c772026-06-26WarningsExact identifier
application number: M012
Dr Kids Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC5533e705-b8d5-71cf-e063-6394a90a20102026-06-26WarningsExact identifier
application number: M012
Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine HydrochlorideACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals265f1ce7-160c-4dda-b2e0-b78d68f962bd2026-06-26WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEBryant Ranch Prepackee052b39-1658-4071-b081-5433c87b5e4a2026-06-25WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLDOLGENCORP, LLCfae1499a-7029-4208-8436-4d330347b9152026-06-25WarningsExact identifier
application number: M012
Sinus Pressure and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLDOLGENCORP, LLC4fe8f124-ac80-40b4-8e1d-96709c459a4f2026-06-25WarningsExact identifier
application number: M012
Allergy and Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE91268cd0-c151-4744-a715-a57af3f3a3142026-06-25WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.a3c4b9c3-bdb1-4f79-bee6-1bb6bec215ea2026-06-24WarningsExact identifier
application number: M012
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEcb475e7f-aec1-415d-9770-07cce4e02c072026-06-24WarningsExact identifier
application number: M012
Broncolito ChildrenDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509f5b72-9894-ef44-e063-6394a90a6d072026-06-23WarningsExact identifier
application number: M012
Neo-Synephrine SeverePHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INC54edaff7-d241-dc90-e063-6294a90ac64d2026-06-23WarningsExact identifier
application number: M012
AXIV Sinus Severe Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC4b81abf9-3ea7-e996-e063-6394a90a71e82026-06-23WarningsExact identifier
application number: M012
AXIV Sinus OVERNIGHTOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC54e03a63-f978-33d4-e063-6394a90a30f22026-06-23WarningsExact identifier
application number: M012
equaline daytime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI9a199782-5d7e-449b-a86c-969746f0e96f2026-06-23WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWalgreen Company542b9861-8055-45f6-8cbf-9fe5cde1c4d92026-06-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.3c1953a1-32e9-6c81-e063-6294a90a9fa22026-06-22WarningsExact identifier
application number: M012
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59db2573-7ebb-4cf9-bfe3-428929bb4eeb2026-06-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250191Halls 7.5 MG Oral LozengePSNaec46410-ffb1-4db4-b232-82110c562f6920
1250189menthol 7.5 MG Oral LozengePSNaec46410-ffb1-4db4-b232-82110c562f6920
1250191menthol 7.5 MG Oral Lozenge [Halls]SBDaec46410-ffb1-4db4-b232-82110c562f6920
1250189menthol 7.5 MG Oral LozengeSCDaec46410-ffb1-4db4-b232-82110c562f6920
1250191Halls 7.5 MG Oral LozengeSYaec46410-ffb1-4db4-b232-82110c562f6920

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
12546-110-0112546011001140 LOZENGE in 1 BAG (12546-110-01) 140 lozenge2023-04-10NoNoCurrent