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 firm2026-10-28

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 152 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough DropsMENTHOLTopco Associates LLCeff16ba3-7e30-aa93-e053-2995a90a64cb2024-10-07WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLTarget Corporation Inc.ebf6bcf5-9384-052a-e053-2a95a90a30a52024-10-07WarningsExact identifier
application number: M012
Rompe Pecho SF Flu SF FluBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBREfficient Laboratories Inc06eac696-e8f6-ac50-e063-6394a90a2ed62024-10-07WarningsExact identifier
application number: M012
dg health nasal fourPHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLCceeeb016-8e46-40b8-9923-8a4270475f452024-10-04WarningsExact identifier
application number: M012
Topcare Nasal FourPHENYLEPHRINE HYDROCHLORIDETopco Associates LLC99bc8829-167b-4cf8-8421-57da369f24cd2024-10-04WarningsExact identifier
application number: M012
basic care nasalPHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC858648f6-f454-4008-9ea8-ad060c2178332024-10-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast FizzCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDENavajo Manufacturing Company Inc.f6068011-ad56-59b4-e053-2995a90ac0162024-10-03WarningsExact identifier
application number: M012
Benadryl UltratabsDIPHENHYDRAMINE HYDROCHLORIDENavajo Manufacturing Company Inc.76433e3c-142c-4704-8b2b-d602f008c3772024-10-02WarningsExact identifier
application number: M012
AfrinOXYMETAZOLINE HYDROCHLORIDENavajo Manufacturing Company Inc.65bf1556-f234-9439-e053-2a91aa0a31942024-10-02WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLProficient Rx LP4eab4344-d95e-4b19-a21e-9c8ad033863a2024-10-01WarningsExact identifier
application number: M012
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLProficient Rx LPa910320b-0585-40bd-928c-0406346281d02024-10-01WarningsExact identifier
application number: M012
CareOne Nasal and Sinus DecongestantPSEUDOEPHEDRINE HCLAmerican Sales Company81b31070-9b03-4ce4-8aac-a334544842ae2024-10-01WarningsExact identifier
application number: M012
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINProficient Rx LP20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d2024-10-01WarningsExact identifier
application number: M012
meijer Nighttime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.1bec5167-5fc5-2405-e063-6294a90a53582024-09-30WarningsExact identifier
application number: M012
good sense tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINA-S Medication Solutions19b3db33-86d1-48f3-9525-c7c87a4b68992024-09-29WarningsExact identifier
application number: M012
nasal decongestant maximum strength non drowsyPSEUDOEPHEDRINE HCLMeijer Distribution Inc8a68ca99-fd76-409a-9769-88830e8720a82024-09-28WarningsExact identifier
application number: M012
good neighbor pharmacy tussin dm maxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmerisource Bergen58687394-b6d2-4d51-bde0-8f2cfa3fe9092024-09-27WarningsExact identifier
application number: M012
good neighbor pharmacy nasalOXYMETAZOLINE HYDROCHLORIDEAmerisource Bergenfaee3aae-e819-4084-a127-3449be353b132024-09-27WarningsExact identifier
application number: M012
Tesalon ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCLOPMX LLC2309620a-ccbc-41e9-e063-6394a90a95202024-09-26WarningsExact identifier
application number: M012
adult cough and chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMeijer, Inc.b11c4cee-bbb5-4585-9d38-6787553e13a02024-09-26WarningsExact 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