FDA.reportPublic FDA data

Halls

Product NDC
12546-320
11-digit product format
125460320
Labeler code
12546
Product ID
12546-320_37b45686-b73a-5d88-e063-6394a90af12a
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
8.8 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL8.8 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
1811174Internal RxNorm lookup
1811176Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
25eaae85-d516-40da-a472-70736ea2b75dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-320-09HallsHoney Lemon9 in 1 PACKAGELOZENGE94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-320HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]3Current NDC, Legacy NDC, 1 package rows20240627_25eaae85-d516-40da-a472-70736ea2b75d.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 87 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens Allergy Dye Free Wal DrylDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN CO.4e64e040-1662-4dc9-b33f-3e119e0b3f7b2025-11-25WarningsExact identifier
application number: M012
WalgreenNASALWALGREENS COd38f8406-d7b9-472c-a472-58968bbdb9932025-11-25WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC780907b8-34ba-4ec8-bcdf-b2a31bd111df2025-11-25WarningsExact identifier
application number: M012
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCd13efbcd-1277-45d0-8389-1ba0337f7a242025-11-25WarningsExact identifier
application number: M012
Childrens Robitussin Elderberry Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCfe903448-b422-42e0-b05b-aeb3e5481e3c2025-11-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC1d4fcb76-22d1-7292-e063-6394a90af9202025-11-25WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGH Soft CHEWSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLCf22248b7-7abd-4df7-a986-dae357ebe8f12025-11-25WarningsExact identifier
application number: M012
ROBITUSSIN Nighttime Cough DM Soft CHEWSDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHaleon US Holdings LLC39468746-e06d-4849-9d06-9af4d14351b02025-11-25WarningsExact identifier
application number: M012
Daytime and Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEGrocery Outlet, Inc.4478fd51-bae3-6108-e063-6394a90a07ca2025-11-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INC.395bb39a-e26f-f4f2-e063-6394a90ae7212025-11-25WarningsExact identifier
application number: M012
day timeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEH E Beaf3af6a-de5b-43fe-83ff-9641646e0f6b2025-11-25WarningsExact identifier
application number: M012
MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid GelsACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERB Health (US) LLC38571853-992f-9998-e063-6394a90a85812025-11-24WarningsExact identifier
application number: M012
Basic Care Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLCe19b561c-fb76-4355-a306-d3dc46930bf22025-11-24WarningsExact identifier
application number: M012
Sinus DecongestionPSEUDOEPHEDRINE HCLKroger Company73c3a9ac-43d6-4ecd-9add-36ca1c40ba9c2025-11-24WarningsExact identifier
application number: M012
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCICardinal Health (Leader) 7000014c507df-fbac-4a09-a66c-b91c2abbf5502025-11-24WarningsExact identifier
application number: M012
Severe Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCIFamily Dollar (FAMILY WELLNESS)e5c90d6e-70aa-4886-bc81-293e0dcf56382025-11-24WarningsExact identifier
application number: M012
Throat Coat Eucalyptus MintMENTHOLTraditional Medicinals, Inc.a7a86f1b-30e8-6f5d-e053-2a95a90a2a822025-11-21WarningsExact identifier
application number: M012
Throat Coat Sweet Orange FennelMENTHOLTraditional Medicinals, Inc.4538248f-11cc-d6b2-e063-6294a90a652c2025-11-21WarningsExact identifier
application number: M012
up and up Daytime Nighttime Childrens Multi Symptom ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationb8a4da0b-e4d3-48e6-b699-cb56c7b67ed72025-11-20WarningsExact identifier
application number: M012
Supress DX Pediatric DropsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVISddb95436-7806-4086-af4d-18a6625b5c832025-11-20WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1811176Halls 8.8 MG Oral LozengePSN25eaae85-d516-40da-a472-70736ea2b75d4
1811174menthol 8.8 MG Oral LozengePSN25eaae85-d516-40da-a472-70736ea2b75d4
1811176menthol 8.8 MG Oral Lozenge [Halls]SBD25eaae85-d516-40da-a472-70736ea2b75d4
1811174menthol 8.8 MG Oral LozengeSCD25eaae85-d516-40da-a472-70736ea2b75d4
1811176Halls 8.8 MG Oral LozengeSY25eaae85-d516-40da-a472-70736ea2b75d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12546-320-09125460320099 LOZENGE in 1 PACKAGE (12546-320-09) 9 lozenge2019-03-240000-00-00NoNoCurrent