Halls

Product NDC
12546-109
11-digit product format
125460109
Labeler code
12546
Product ID
12546-109_37b2eaa4-fe74-b6c0-e063-6394a90a5321
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
2019-03-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage12546-10912546-109-01DDiscontinued by firm2026-10-20
excluded packagepackage12546-10912546-109-02DDiscontinued by firm2026-10-20
excluded packagepackage12546-10912546-109-03DDiscontinued by firm2026-10-20
excluded packagepackage12546-10912546-109-04DDiscontinued by firm2026-10-20
excluded packagepackage12546-10912546-109-16DDiscontinued by firm2026-10-20
excluded packagepackage12546-10912546-109-18DDiscontinued by firm2026-10-20
excluded packagepackage12546-10912546-109-24DDiscontinued by firm2026-10-20
excluded packagepackage12546-10912546-109-40DDiscontinued by firm2026-10-20
excluded packagepackage12546-10912546-109-96DDiscontinued by firm2026-10-20

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 2 · 108 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0512546-109-24d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-109-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-109-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-109-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-109-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-109-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-109-96d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-109-18d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-109-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2612546-109-24f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-109-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-109-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-109-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-109-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-109-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-109-96f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-109-18f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-109-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3112546-109-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-109-182ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-109-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-109-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-109-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-109-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-109-242ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-109-962ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-109-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2812546-109-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-109-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-109-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-109-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-109-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-109-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-109-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-109-96a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-109-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2112546-109-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-109-18cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-109-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-109-16cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-109-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-109-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-109-24cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-109-96cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-109-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1012546-109-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-109-18cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-109-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-109-16cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-109-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-109-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-109-24cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-109-96cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-109-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3112546-109-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3112546-109-18302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3112546-109-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3112546-109-16302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3112546-109-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3112546-109-03302b2466d912…e7b80fea0513…

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
Cherry
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
5f4af8e8-8550-45c7-a199-694efac9e7beAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-109-00HallsCherry140 in 1 BAGLOZENGE14018
12546-109-01HallsCherry100000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLOZENGE10000018
12546-109-02HallsCherry150000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLOZENGE15000018
12546-109-03HallsCherry2400 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLOZENGE240018
12546-109-04HallsCherry720 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLOZENGE72018
12546-109-14HallsCherry14 in 1 BAGLOZENGE1418
12546-109-16HallsCherry16 in 1 BAGLOZENGE1618
12546-109-18HallsCherry18 in 1 BAGLOZENGE1818
12546-109-24HallsCherry24 in 1 BAGLOZENGE2418
12546-109-30HallsCherry30 in 1 BAGLOZENGE3018
12546-109-40HallsCherry40 in 1 BAGLOZENGE4018
12546-109-80HallsCherry80 in 1 BAGLOZENGE8018
12546-109-89HallsCherry200 in 1 BAGLOZENGE20018
12546-109-90HallsCherry250 in 1 JARLOZENGE25018
12546-109-96HallsCherry96 in 1 BAGLOZENGE9618
12546-109-99HallsCherry160 in 1 PACKAGELOZENGE16018

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-109HALLS CHERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]17Current NDC, Legacy NDC, 16 package rows20240517_5f4af8e8-8550-45c7-a199-694efac9e7be.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 27 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Fast-Max Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC3270f369-7a40-186d-e063-6394a90a85262026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCfe44d1ee-1e03-b74f-e053-6294a90a8bb42026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC31ac6883-ffcd-39de-e063-6294a90a52dd2026-05-19WarningsExact identifier
application number: M012
MUCINEX DAY TIME PAIN, HEADACHE and MUCUS CONGESTION and MUCINEX NIGHT TIME HEADACHE, COUGH and FEVER Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC325b41e1-f8d2-02ee-e063-6394a90aafff2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC326f1fd3-73ab-e515-e063-6294a90ab2222026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC6c85df30-a601-4de6-9fd6-818265d799ff2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC7050b583-c09b-4457-9a9c-70c0923b62c02026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC27312ee4-d1f4-4a95-9c45-91fa5a01f5ba2026-05-19WarningsExact identifier
application number: M012
Mucinex Rapid Clear Daytime Pain, Headache, and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC37de53a7-5546-3804-e063-6294a90a0fb52026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC36b07e49-c72c-45e5-e063-6394a90a804a2026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus Max Clear and Cool Severe CongestionOXYMETAZOLINE HCIReckitt Benckiser LLC2ee95e17-bd94-d717-e063-6294a90a21732026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus Max Sinus Pressure Severe CongestionOXYMETAZOLINE HCIReckitt Benckiser LLC2eeafd83-230c-af92-e063-6294a90a984e2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Congestion and Headache Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd7017328-f8af-4601-9232-dc1104feaa0a2026-05-19WarningsExact identifier
application number: M012
Mucinex Rapid Clear Pain Headache and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC32375b12-75ed-d605-e063-6294a90ad0042026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus-Max Pressure, Pain and Cough Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC07da45b5-d05e-41b1-b233-f7034d556a8d2026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion and Pain Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCad4e0e4d-cc1f-4176-835f-3ba76564c6342026-05-19WarningsExact identifier
application number: M012
Childrens Mucinex Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC60daf6e2-ded8-44e6-bd8d-9d221384adde2026-05-19WarningsExact identifier
application number: M012
Mucinex Childrens Mini Melts Cold and FluACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC401fe0a0-ec97-5248-e063-6394a90af27f2026-05-19WarningsExact identifier
application number: M012
Childrens Cough and Congestion, Childrens Cold and Cough Day, NightDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINWALMART INC.312ae879-1124-40a4-b2ba-3f30708400212026-05-19WarningsExact identifier
application number: M012
GOOD SENSE DAYTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEL. Perrigo Company2597e84c-18b4-41a9-8e6a-ff0c4c1f06122026-05-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896994Halls 5.8 MG Oral LozengePSN5f4af8e8-8550-45c7-a199-694efac9e7be18
476973menthol 5.8 MG Oral LozengePSN5f4af8e8-8550-45c7-a199-694efac9e7be18
896994menthol 5.8 MG Oral Lozenge [Halls]SBD5f4af8e8-8550-45c7-a199-694efac9e7be18
476973menthol 5.8 MG Oral LozengeSCD5f4af8e8-8550-45c7-a199-694efac9e7be18
896994Halls 5.8 MG Oral LozengeSY5f4af8e8-8550-45c7-a199-694efac9e7be18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12546-109-0012546010900140 LOZENGE in 1 BAG (12546-109-00) 140 lozenge2023-04-10NoNoCurrent
12546-109-0112546010901100000 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-109-01) 100000 lozenge2019-12-020000-00-00NoNoCurrent
12546-109-0212546010902150000 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-109-02) 150000 lozenge2019-12-020000-00-00NoNoCurrent
12546-109-03125460109032400 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-109-03) 2400 lozenge2019-12-020000-00-00NoNoCurrent
12546-109-0412546010904720 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-109-04) 720 lozenge2019-12-020000-00-00NoNoCurrent
12546-109-141254601091414 LOZENGE in 1 BAG (12546-109-14) 14 lozenge2019-03-310000-00-00NoNoCurrent
12546-109-161254601091616 LOZENGE in 1 BAG (12546-109-16) 16 lozenge2019-03-310000-00-00NoNoCurrent
12546-109-181254601091818 LOZENGE in 1 BAG (12546-109-18) 18 lozenge2019-03-310000-00-00NoNoCurrent
12546-109-241254601092424 LOZENGE in 1 BAG (12546-109-24) 24 lozenge2019-12-020000-00-00NoNoCurrent
12546-109-301254601093030 LOZENGE in 1 BAG (12546-109-30) 30 lozenge2019-03-310000-00-00NoNoCurrent
12546-109-401254601094040 LOZENGE in 1 BAG (12546-109-40) 40 lozenge2019-03-310000-00-00NoNoCurrent
12546-109-801254601098080 LOZENGE in 1 BAG (12546-109-80) 80 lozenge2019-03-310000-00-00NoNoCurrent
12546-109-8912546010989200 LOZENGE in 1 BAG (12546-109-89) 200 lozenge2019-03-310000-00-00NoNoCurrent
12546-109-9012546010990250 LOZENGE in 1 JAR (12546-109-90) 250 lozenge2024-05-20NoNoCurrent
12546-109-961254601099696 LOZENGE in 1 BAG (12546-109-96) 96 lozenge2019-03-310000-00-00NoNoCurrent
12546-109-9912546010999160 LOZENGE in 1 PACKAGE (12546-109-99) 160 lozenge2019-03-310000-00-00NoNoCurrent