Halls

Product NDC
12546-110
11-digit product format
125460110
Labeler code
12546
Product ID
12546-110_51b2efc4-6f46-16dc-e063-6294a90a509e
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
7.5 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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 packagepackage12546-11012546-110-02DDiscontinued by firm2026-10-15
excluded packagepackage12546-11012546-110-03DDiscontinued by firm2026-10-15
excluded packagepackage12546-11012546-110-04DDiscontinued by firm2026-10-15
excluded packagepackage12546-11012546-110-16DDiscontinued by firm2026-10-15
excluded packagepackage12546-11012546-110-18DDiscontinued by firm2026-10-15
excluded packagepackage12546-11012546-110-24DDiscontinued by firm2026-10-15
excluded packagepackage12546-11012546-110-40DDiscontinued by firm2026-10-15
excluded packagepackage12546-11012546-110-96DDiscontinued by firm2026-10-15
excluded packagepackage12546-11012546-110-99DDiscontinued 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 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 2025-12-0512546-110-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-110-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-110-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-110-18d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-110-96d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-110-99d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-110-24d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-110-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-110-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2612546-110-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-110-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-110-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-110-18f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-110-96f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-110-99f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-110-24f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-110-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-110-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3112546-110-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-110-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-110-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-110-242ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-110-992ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-110-962ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-110-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-110-182ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-110-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2812546-110-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-110-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-110-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-110-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-110-99a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-110-96a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-110-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-110-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-110-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2112546-110-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-110-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-110-16cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-110-24cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-110-99cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-110-96cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-110-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-110-18cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-110-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1012546-110-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-110-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-110-16cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-110-24cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-110-99cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-110-96cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-110-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-110-18cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-110-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3112546-110-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3112546-110-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3112546-110-16302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3112546-110-24302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3112546-110-99302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3112546-110-96302b2466d912…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
Honey Lemon
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL7.5 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
1250189Internal RxNorm lookup
1250191Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aec46410-ffb1-4db4-b232-82110c562f69Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-110-00HallsHoney Lemon250 in 1 JARLOZENGE25020
12546-110-01HallsHoney Lemon140 in 1 BAGLOZENGE14020
12546-110-02HallsHoney Lemon150000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLOZENGE15000020
12546-110-03HallsHoney Lemon2400 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLOZENGE240020
12546-110-04HallsHoney Lemon720 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLOZENGE72020
12546-110-14HallsHoney Lemon14 in 1 PACKAGELOZENGE1420
12546-110-16HallsHoney Lemon16 in 1 BAGLOZENGE1620
12546-110-18HallsHoney Lemon18 in 1 BAGLOZENGE1820
12546-110-24HallsHoney Lemon24 in 1 BAGLOZENGE2420
12546-110-30HallsHoney Lemon30 in 1 BAGLOZENGE3020
12546-110-40HallsHoney Lemon40 in 1 BAGLOZENGE4020
12546-110-80HallsHoney Lemon80 in 1 BAGLOZENGE8020
12546-110-96HallsHoney Lemon96 in 1 BAGLOZENGE9620
12546-110-99HallsHoney Lemon160 in 1 BAGLOZENGE16020

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-110HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]18Current NDC, Legacy NDC, 14 package rows20240622_aec46410-ffb1-4db4-b232-82110c562f69.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
1250191Halls 7.5 MG Oral LozengePSNaec46410-ffb1-4db4-b232-82110c562f6920
1250189menthol 7.5 MG Oral LozengePSNaec46410-ffb1-4db4-b232-82110c562f6920
1250191menthol 7.5 MG Oral Lozenge [Halls]SBDaec46410-ffb1-4db4-b232-82110c562f6920
1250189menthol 7.5 MG Oral LozengeSCDaec46410-ffb1-4db4-b232-82110c562f6920
1250191Halls 7.5 MG Oral LozengeSYaec46410-ffb1-4db4-b232-82110c562f6920

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12546-110-0012546011000250 LOZENGE in 1 JAR (12546-110-00) 250 lozenge2022-07-060000-00-00NoNoCurrent
12546-110-0112546011001140 LOZENGE in 1 BAG (12546-110-01) 140 lozenge2023-04-10NoNoCurrent
12546-110-0212546011002150000 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-110-02) 150000 lozenge2019-12-020000-00-00NoNoCurrent
12546-110-03125460110032400 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-110-03) 2400 lozenge2019-12-020000-00-00NoNoCurrent
12546-110-0412546011004720 LOZENGE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (12546-110-04) 720 lozenge2019-12-020000-00-00NoNoCurrent
12546-110-141254601101414 LOZENGE in 1 PACKAGE (12546-110-14) 14 lozenge2019-03-240000-00-00NoNoCurrent
12546-110-161254601101616 LOZENGE in 1 BAG (12546-110-16) 16 lozenge2019-03-240000-00-00NoNoCurrent
12546-110-181254601101818 LOZENGE in 1 BAG (12546-110-18) 18 lozenge2019-03-240000-00-00NoNoCurrent
12546-110-241254601102424 LOZENGE in 1 BAG (12546-110-24) 24 lozenge2019-12-020000-00-00NoNoCurrent
12546-110-301254601103030 LOZENGE in 1 BAG (12546-110-30) 30 lozenge2019-03-240000-00-00NoNoCurrent
12546-110-401254601104040 LOZENGE in 1 BAG (12546-110-40) 40 lozenge2019-03-240000-00-00NoNoCurrent
12546-110-801254601108080 LOZENGE in 1 BAG (12546-110-80) 80 lozenge2019-03-240000-00-00NoNoCurrent
12546-110-961254601109696 LOZENGE in 1 BAG (12546-110-96) 96 lozenge2019-03-240000-00-00NoNoCurrent
12546-110-9912546011099160 LOZENGE in 1 BAG (12546-110-99) 160 lozenge2019-03-240000-00-00NoNoCurrent