Halls

Product NDC
12546-104
11-digit product format
125460104
Labeler code
12546
Product ID
12546-104_307a57f2-a64a-23f5-e063-6394a90a39fc
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
2019-06-10
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage12546-10412546-104-25DDiscontinued by firm2026-10-27
excluded packagepackage12546-10412546-104-30DDiscontinued by firm2026-10-27

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 1 · 24 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 2025-12-0512546-104-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512546-104-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2612546-104-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612546-104-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3112546-104-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112546-104-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2812546-104-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812546-104-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2112546-104-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112546-104-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1012546-104-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012546-104-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3112546-104-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3112546-104-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2012546-104-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2012546-104-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1012546-104-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1012546-104-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0812546-104-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0812546-104-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0312546-104-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0312546-104-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0912546-104-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0912546-104-25557ba5c1ecfa…9c80585c8c6e…

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
Sugar Free Black 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
bd2a311a-bf0c-4365-af9b-76675c243b22Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-104-25HallsSugar Free Black Cherry25 in 1 BAGLOZENGE259
12546-104-30HallsSugar Free Black Cherry30 in 1 BAGLOZENGE309
12546-104-70HallsSugar Free Black Cherry70 in 1 BAGLOZENGE709

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-104HALLS SUGAR FREE BLACK CHERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]9Current NDC, Legacy NDC, 3 package rows20250319_bd2a311a-bf0c-4365-af9b-76675c243b22.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 124 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SDA Laboratories TussinGUAIFENESINSDA Laboratories, Inc.2a444cc8-96be-9432-e063-6394a90a1b632024-12-27WarningsExact identifier
application number: M012
SDA Laboratories Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINSDA Laboratories, Inc.2a445f31-818d-11b1-e063-6294a90a8cb12024-12-27WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDERichmond Pharmaceuticals Inc.f184b2aa-91a4-44f9-b688-d4e3181819842024-12-26WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDERichmond Pharmaceuticals, Inc.2792032a-ff0f-4d5f-a8e3-b8b8c54f4e992024-12-26WarningsExact identifier
application number: M012
OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.c7b1f980-9b0d-4f63-a70d-fd366658f8632024-12-26WarningsExact identifier
application number: M012
OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.2ee2b332-9b85-45a6-b242-3f0ebfbd08a62024-12-26WarningsExact identifier
application number: M012
OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCaebc7cf8-aaf7-4746-89f5-a64d0be1641e2024-12-26WarningsExact identifier
application number: M012
Foster and Thrive Chest Congestion ReliefGUAIFENESINStrategic Sourcing Services LLCa1661a66-5e8c-4144-9c82-cbbcc75fb2222024-12-23WarningsExact identifier
application number: M012
Geri DrylDIPHENHYDRAMINE HCLGERI-CARE PHARMACEUTICALS, CORP34d36146-6827-4800-8483-c0edb8f4cc282024-12-23WarningsExact identifier
application number: M012
Guaiasorb DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp6299e352-116e-43f2-b40f-c704a7bd5d612024-12-23WarningsExact identifier
application number: M012
Equaline Chest Congestion ReliefGUAIFENESINUnited Natural Foods, Inc. dba UNFIad9fde8b-10cd-4778-917d-1ed6b67e5ab12024-12-23WarningsExact identifier
application number: M012
Equaline Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINUnited Natural Foods, Inc. dba UNFIa40f5893-eb96-4e0e-b965-d78293c48dc92024-12-23WarningsExact identifier
application number: M012
Tukol X-Pecto Miel Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.b9d32964-5bd7-44b0-be98-827d5310ed4f2024-12-20WarningsExact identifier
application number: M012
Halls Honey VanillaMENTHOLMondelez Global LLC8e94a1b8-8915-4595-b097-8a0a319d54aa2024-12-20WarningsExact identifier
application number: M012
Halls Sugar Free Mentho-LyptusMENTHOLMondelez Global LLC96046858-c57b-426e-8279-91b35e05bcdb2024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, Best ChoiceLEVMETAMFETAMINEValu Merchandisers Company3f1c086c-bc22-4abb-9921-565a13f30c202024-12-20WarningsExact identifier
application number: M012
Vapor InhalerLEVMETAMFETAMINE NASAL DECONGESTANTWalgreens77924474-ccc7-497b-9168-91490bcfadfc2024-12-20WarningsExact identifier
application number: M012
LevmetamfetamineLEVMETAMFETAMINEMeijer, Inc.d11e916f-90a6-4099-bf83-75f2dfbd62662024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, DG healthLEVMETAMFETAMINEDolgencorp Inc.5dbc5a2d-feae-40d8-a8d4-1d6155a1bbd32024-12-20WarningsExact identifier
application number: M012
Tukol Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.aef2ad43-145d-4abc-bccc-2c5fdd6882f92024-12-20WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896994Halls 5.8 MG Oral LozengePSNbd2a311a-bf0c-4365-af9b-76675c243b229
476973menthol 5.8 MG Oral LozengePSNbd2a311a-bf0c-4365-af9b-76675c243b229
896994menthol 5.8 MG Oral Lozenge [Halls]SBDbd2a311a-bf0c-4365-af9b-76675c243b229
476973menthol 5.8 MG Oral LozengeSCDbd2a311a-bf0c-4365-af9b-76675c243b229
896994Halls 5.8 MG Oral LozengeSYbd2a311a-bf0c-4365-af9b-76675c243b229

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12546-104-251254601042525 LOZENGE in 1 BAG (12546-104-25) 25 lozenge2019-06-100000-00-00NoNoCurrent
12546-104-301254601043030 LOZENGE in 1 BAG (12546-104-30) 30 lozenge2019-06-100000-00-00NoNoCurrent
12546-104-701254601047070 LOZENGE in 1 BAG (12546-104-70) 70 lozenge2019-06-100000-00-00NoNoCurrent