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 firm2026-10-23
excluded packagepackage12546-11012546-110-03DDiscontinued by firm2026-10-23
excluded packagepackage12546-11012546-110-04DDiscontinued by firm2026-10-23
excluded packagepackage12546-11012546-110-16DDiscontinued by firm2026-10-23
excluded packagepackage12546-11012546-110-18DDiscontinued by firm2026-10-23
excluded packagepackage12546-11012546-110-24DDiscontinued by firm2026-10-23
excluded packagepackage12546-11012546-110-40DDiscontinued by firm2026-10-23
excluded packagepackage12546-11012546-110-96DDiscontinued by firm2026-10-23
excluded packagepackage12546-11012546-110-99DDiscontinued by firm2026-10-23

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 153 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
COLD AND FLU NIGHTTIME SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORP9de9c34e-a0ca-cdf9-e053-2a95a90a93d32024-09-25WarningsExact identifier
application number: M012
Basic Care Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLC8f3317f6-4ae8-474b-93c3-25e256519cb82024-09-25WarningsExact identifier
application number: M012
berkley and jensen tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINBJWCb2de91c9-6af0-4881-8d2d-a69d90c8dfcd2024-09-24WarningsExact identifier
application number: M012
Tussin DM Cough and Chest Non DrowsyDEXTROMETHORPHAN HBR, GUAIFENESINWinCo Foods, LLC13eb459c-3075-4038-8062-9ee7175b2ab92024-09-24WarningsExact identifier
application number: M012
equaline nasal decongestant non drowsy maximum strengthPSEUDOEPHEDRINE HCLUnited Natural Foods, Inc. dba UNFI8897580a-709a-4643-8264-ad003d90cbff2024-09-22WarningsExact identifier
application number: M012
Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLDabur India Limited22916978-303d-e62a-e063-6394a90a21002024-09-20WarningsExact 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