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 firm2026-10-21

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 69 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safetussin High Blood Pressure and diabetes Cough, Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES279e309c-040d-4001-808d-b7d986a9a1d82025-12-23WarningsExact identifier
application number: M012
Sinus PE Head Congestion and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED76fd1f8e-2670-421c-a9e6-c8adefb7962e2025-12-23WarningsExact identifier
application number: M012
Leader Cough Drops Vanilla HoneyMENTHOLCardinal Health 110, LLC. DBA Leader1f6f1218-be7d-4b80-ad0d-eb4d1a54a1e22025-12-22WarningsExact identifier
application number: M012
Leader Throat Soothing Drops Creamy StrawberryTHROAT SOOTHING CREAMY STRAWBERRYCardinal Health 110, LLC. DBA Leader26cd146a-6461-604f-e063-6394a90ac36e2025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CREAMY STRAWBERRYMedical Group Care LLC043a5e11-30c3-44cd-e063-6394a90a318b2025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CHERRYMedical Group Care LLC29f3f6dd-751e-1dfe-e063-6394a90a0dbb2025-12-22WarningsExact identifier
application number: M012
MGC Cough DropsMENTHOLMedical Group Care LLC437f6b77-ecf8-2cd8-e063-6394a90ad45d2025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS HONEYMedical Group Care LLCf4a92a69-e562-1cec-e053-2a95a90a01652025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS VANILLA HONEYMedical Group Care LLC043999bc-3efe-5d29-e063-6294a90a95f42025-12-22WarningsExact identifier
application number: M012
MGC Health Throat Soothing Drops Creamy StrawberryPECTINMedical Group Care LLC3fa195b5-0712-aada-e063-6394a90a90692025-12-22WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Creamy StrawberryPECTIN, MENTHOLChain Drug Marketing Association, Inc.18d28b91-55a7-4d0d-8404-4f21afdef9892025-12-22WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS CHERRYDISCOUNT DRUG MART0668492e-c47e-b7cf-e063-6394a90a309b2025-12-22WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS MENTHOLDISCOUNT DRUG MART06574e56-13b8-a3af-e063-6394a90a48672025-12-22WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS HONEY LEMONDISCOUNT DRUG MART0668ddcc-0214-8e97-e063-6294a90a4f322025-12-22WarningsExact identifier
application number: M012
caring mill Cough drops CHERRYMENTHOLFSA STORE INC.9d666061-f7a8-4318-8db1-b65373689e1d2025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS CHERRYPharmacy Value Alliance LLC018f4790-8785-94f4-e063-6394a90a19162025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS HONEY LEMONPharmacy Value Alliance LLC0191fcf7-abc1-e583-e063-6294a90a78542025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS MENTHOLPharmacy Value Alliance LLC019211bf-dd4b-5f4c-e063-6294a90aacfb2025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS BLACK CHERRY SUGAR FREEPharmacy Value Alliance LLC018f20b1-06e0-eb13-e063-6394a90a5ec52025-12-22WarningsExact identifier
application number: M012
Quality Choice Cherry Cough DropsCHERRY COUGH DROPSChain Drug Marketing Association, Inc.6a407092-4b71-4156-b4ad-930782b5fb432025-12-22WarningsExact 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