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 34 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids AllergyDIPHENHYDRAMINE HCLGenexa Inc.a7bc5f7c-eaeb-25d0-e053-2a95a90a9ec42026-05-08WarningsExact identifier
application number: M012
day time non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPublix Super Markets Incf4fd597f-bca2-4ed4-b353-6c734f2f885c2026-05-08WarningsExact identifier
application number: M012
Daytime Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS Pharmacyd8339bb0-5da3-4f34-a819-339643cf4a972026-05-08WarningsExact identifier
application number: M012
severe tussin cfACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDa26afc33-533e-4dc0-ab25-21be87356e222026-05-08WarningsExact identifier
application number: M012
SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketcdd53eba-1fa2-49c1-b03d-c32f309da7fb2026-05-08WarningsExact identifier
application number: M012
Benadryl Allergy Liqui-GelsDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCbfeae100-e2d1-4607-be3b-2d9b15cd4f7f2026-05-07WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLH E B6503761f-37ae-4f39-b727-cb75d4c4a3c92026-05-07Warnings, Adverse reactionsExact identifier
application number: M012
Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLCad199488-a4be-4b6e-b806-67ce8a6e907e2026-05-07WarningsExact identifier
application number: M012
good sense nasalOXYMETAZOLINE HCLL. Perrigo Company5d42adb9-3625-4072-a6b1-29a229f255c82026-05-07WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company4856cd7b-ccdf-4546-9c65-236ebaac3dca2026-05-06WarningsExact identifier
application number: M012
Mucus Relief All in One Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)0f8928a1-97ef-4128-b8d2-20bdb6e5b6ac2026-05-06WarningsExact identifier
application number: M012
daytime cough and chest congestion dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED175cc2d0-0202-4e38-8af2-9fc126b7412d2026-05-06WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals90fae0fa-da07-4ea8-bdbd-39c2ed99ae592026-05-06WarningsExact identifier
application number: M012
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals5d8b980f-0011-41e3-a881-ad10fe3990792026-05-06WarningsExact identifier
application number: M012
HALLS MentholyptusMENTHOLMondelez Global LLC38d12374-e2c7-444c-e063-6294a90a42b32026-05-06WarningsExact identifier
application number: M012
HALLS MentholyptusMENTHOLMondelez Global LLC1ab295ff-94b1-c938-e063-6294a90a98fd2026-05-06WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.512af63d-2f09-4baa-e063-6394a90a86bd2026-05-06WarningsExact identifier
application number: M012
Thieves Chest RubCHEST RUBYoung Living Essential Oils, LC.9b7f125e-6caa-c53e-e053-2a95a90a737e2026-05-06WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief Plus Pain and HeadacheACETAMINOPHEN, GUAIFENESINShield Pharmaceuticals Corpf20c0db1-dcf3-4bfc-b3e4-930398f82dc92026-05-06WarningsExact identifier
application number: M012
NitetimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Inc8aa6492b-1723-4c6b-82ee-4f800301c6ad2026-05-06WarningsExact 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