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 firm2026-10-21
excluded packagepackage12546-11012546-110-03DDiscontinued by firm2026-10-21
excluded packagepackage12546-11012546-110-04DDiscontinued by firm2026-10-21
excluded packagepackage12546-11012546-110-16DDiscontinued by firm2026-10-21
excluded packagepackage12546-11012546-110-18DDiscontinued by firm2026-10-21
excluded packagepackage12546-11012546-110-24DDiscontinued by firm2026-10-21
excluded packagepackage12546-11012546-110-40DDiscontinued by firm2026-10-21
excluded packagepackage12546-11012546-110-96DDiscontinued by firm2026-10-21
excluded packagepackage12546-11012546-110-99DDiscontinued 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 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 121 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepackf40bfdfc-1cb4-4604-9790-fb8d1d5173c62025-01-31WarningsExact identifier
application number: M012
NIGHTIME COLD AND FLUNIGHTIME COLD AND FLUTARGET CORP9dee9b92-eac9-b07d-e053-2995a90a06022025-01-31WarningsExact identifier
application number: M012
Rugby Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINBryant Ranch Prepack7b23faa9-40c8-4cea-b9fb-487cce2664af2025-01-31WarningsExact identifier
application number: M012
BENADRYL AllergyDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC224ba2a3-1a93-29c8-e063-6394a90a9bef2025-01-30WarningsExact identifier
application number: M012
Extra Strength Nite-Time Pain Relief430R WALGREENS ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HCL 25 MG TABLETWALGREENSc25cff5a-93f5-62aa-e053-2a95a90aa7b42025-01-30WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWALGREENSdbf5c814-4e69-13ac-e053-2a95a90a49a32025-01-30WarningsExact identifier
application number: M012
Mucus DM Fast Max Day Cold and Flu and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWALGREENSf3770976-de73-52b8-e053-2995a90aad4f2025-01-30WarningsExact identifier
application number: M012
Dextromethorphan HBr and Guaifenesin Oral SolutionDEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTIONKESIN PHARMA CORPORATION284eae44-81bc-400c-e063-6394a90af4462025-01-30WarningsExact identifier
application number: M012
Vapor ShowerMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.26c82bc3-5753-4d56-96a4-a3f9c8c267d02025-01-30WarningsExact identifier
application number: M012
Vapor ShowerMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.8095b211-8ae7-44e5-b89a-b7f730e28d512025-01-30WarningsExact identifier
application number: M012
Vapor ShowerMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2cf2f35b-5d59-e3ff-e063-6294a90a9b452025-01-30WarningsExact identifier
application number: M012
Sinus Congestion and Pain Relief Non-Drowsy, DaytimeACETAMINOPHEN AND PHENYLEPHRINE HCLRite Aid Corporation8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c52025-01-30WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cold and FluACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDERB Health (US) LLC2ce20ab5-5f2d-1c97-e063-6394a90ad67b2025-01-29WarningsExact identifier
application number: M012
Guaifenesin and DextromethorphanGUAIFENESIN AND DEXTROMETHORPHANMajor Pharmaceuticals97b137c9-0bec-409a-91f7-e298c296578b2025-01-29WarningsExact identifier
application number: M012
Childrens Mucus and Cough ReliefDEXTROMETHORPHAN HBR, GUAIFENESINCVS1dc17665-62ce-f7f5-e063-6294a90af8512025-01-29WarningsExact identifier
application number: M012
UP AND UP NO DRIP NASALOXYMETAZOLINE HYDROCHLORIDETarget Corporation760d6d0f-00fc-40bc-858d-83a0827d139f2025-01-29WarningsExact identifier
application number: M012
Guaifenesin and DextromethorphanGUAIFENESIN AND DEXTROMETHORPHANMajor Pharmaceuticals51e48201-bb62-4e89-85eb-e4a416f935222025-01-29WarningsExact identifier
application number: M012
Severe Congestion and Cough MaxDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBest Choice8c878e47-94f4-484f-bdd8-6d87ac2440d82025-01-28WarningsExact identifier
application number: M012
Cough and Cold TherapyCAMPHOR, MENTHOL, EUCALYPTUS OILEverlaan Organics Inc088be461-7afc-586a-e063-6294a90a700b2025-01-27WarningsExact identifier
application number: M012
Cough and Cold Therapy For KidsCAMPHOR, MENTHOL, EUCALYPTUS OILEverlaan Organics Inc088df369-114c-db4f-e063-6394a90acfac2025-01-27WarningsExact 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