FDA.reportPublic FDA data

Halls

Product NDC
12546-640
11-digit product format
125460640
Labeler code
12546
Product ID
12546-640_1fbb2a9f-6a86-45fe-e063-6394a90a946f
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
2019-06-03
Substance
MENTHOL
Active strength
5.8 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage12546-64012546-640-25DDiscontinued by firm2026-10-15

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
Sugar Free Mountain Menthol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5.8 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
476973Internal RxNorm lookup
896994Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
54e0d57e-1f48-45e2-86b3-0e50775996f4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-640-01HallsSugar Free Mountain Menthol150000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLOZENGE1500008
12546-640-25HallsSugar Free Mountain Menthol25 in 1 BAGLOZENGE258
12546-640-70HallsSugar Free Mountain Menthol70 in 1 BAGLOZENGE708
12546-640-98HallsSugar Free Mountain Menthol225 in 1 JARLOZENGE2258

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AHALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2
MENTHOLACTIVE MOIETYL7T10EIP3AHALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2
ISOMALTINACTIVE INGREDIENTS870P55O2WHALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RHALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-640HALLS SUGAR FREE MOUNTAIN MENTHOL (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]8Current NDC, Legacy NDC, 4 package rows20240816_54e0d57e-1f48-45e2-86b3-0e50775996f4.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 12 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyc9342ad2-84dc-4f4c-9b05-c6e5c1c7989e2026-08-04WarningsExact identifier
application number: M012
dg health cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc3d8ce88e-9f40-4b58-a811-160ddbfb81122026-08-04WarningsExact identifier
application number: M012
ValuRx Dye Free Allergy ReliefDIPHENHYDRAMINE HCL 25 MGShield Pharmaceuticals Corpca60a413-b02e-48ce-985d-4d415780c6792026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRRite Aid Corporation20af2586-f8ac-47a3-9f8d-de255f9193282026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc150b68ba-3ed4-4533-9118-74e76eaf6e482026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationce393bff-498b-42e6-a41c-bbfbc58fb42c2026-08-04WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader3b8662bf-3abb-4e54-af9c-5fa1d2e190032026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRFamily Dollar Services Inc74ee96f7-75ac-4b60-a2b8-13b050e238042026-08-04WarningsExact identifier
application number: M012
Mucus Relief PEGUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycb1c1922-5dc6-520d-e77e-e951726d97012026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDOLGENCORP, LLC7a662caf-9cbb-4d55-b0b2-43f1f1289ec72026-08-04WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLCda053bc3-e790-4ae9-a406-2629640e97e72026-08-04WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company4d199dc7-253f-48fd-a77d-f8b10f724dd12026-08-04WarningsExact identifier
application number: M012
daytime nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc80aae1c3-a616-442b-842e-177db957a69c2026-08-04WarningsExact identifier
application number: M012
Mucus Relief DGUAIFENESIN, PSEUDOEPHEDRINE HCLMeijer Distribution Inc383281d7-0d25-4423-ace2-d2985f2c37d02026-08-03WarningsExact identifier
application number: M012
equaline daytime and nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI8fc2389c-9657-4dbe-a32b-df8245fc67ca2026-08-03WarningsExact identifier
application number: M012
Acetominophen, Dextromethorphan hydrobromideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDESoftgel Healthcare Private Limited5302bc6d-d947-31c3-e063-6294a90a09f32026-08-03WarningsExact identifier
application number: M012
MUCINEX INSTASOOTHE COUGHDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC0d99237c-0b52-0af6-e063-6394a90aba142026-08-03WarningsExact identifier
application number: M012
daytime nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company182a105b-bd49-42b5-b4e0-46e5ec0197e32026-08-03WarningsExact identifier
application number: M012
equaline nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI05e089e7-8772-4bf4-914f-6a26067ee7192026-08-03WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEMajor Pharmaceuticals66b918d3-5c37-4889-b981-819ced8b61472026-08-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896994Halls 5.8 MG Oral LozengePSN54e0d57e-1f48-45e2-86b3-0e50775996f48
476973menthol 5.8 MG Oral LozengePSN54e0d57e-1f48-45e2-86b3-0e50775996f48
896994menthol 5.8 MG Oral Lozenge [Halls]SBD54e0d57e-1f48-45e2-86b3-0e50775996f48
476973menthol 5.8 MG Oral LozengeSCD54e0d57e-1f48-45e2-86b3-0e50775996f48
896994Halls 5.8 MG Oral LozengeSY54e0d57e-1f48-45e2-86b3-0e50775996f48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12546-640-0112546064001150000 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-640-01) 150000 lozenge2024-11-05NoNoCurrent
12546-640-251254606402525 LOZENGE in 1 BAG (12546-640-25) 25 lozenge2019-06-030000-00-00NoNoCurrent
12546-640-701254606407070 LOZENGE in 1 BAG (12546-640-70) 70 lozenge2019-06-030000-00-00NoNoCurrent
12546-640-9812546064098225 LOZENGE in 1 JAR (12546-640-98) 225 lozenge2024-07-02NoNoCurrent