FDA.reportPublic FDA data

Halls

Product NDC
12546-334
11-digit product format
125460334
Labeler code
12546
Product ID
12546-334_1bc29960-5e7b-e8ab-e063-6294a90a3f80
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
2019-04-07
Substance
MENTHOL
Active strength
6.4 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Mentholyptus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL6.4 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
1857613Internal RxNorm lookup
1857615Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5292c5b-5608-4e13-afc2-4f3d7133da88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-334-09HallsMentholyptus9 in 1 PACKAGELOZENGE93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-334HALLS MENTHOLYPTUS (MENTHOL) LOZENGE [MONDELĒZ GLOBAL LLC]3Current NDC, Legacy NDC, 1 package rows20240627_f5292c5b-5608-4e13-afc2-4f3d7133da88.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 43 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MGC HealthCOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f3f6dd-751d-1dfe-e063-6394a90a0dbb2026-03-25WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS MENTHOL SUGAR-FREEMedical Group Care LLCf4a90af2-47af-ac8c-e053-2a95a90ab97e2026-03-25WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS BLACK CHERRY SUGAR FREEMedical Group Care LLC043b3639-ab38-adff-e063-6394a90a2ade2026-03-25WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATEWinCo Foods, LLC4535fa03-64ac-4ec6-9d0c-b372bb12773b2026-03-25WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED3e73a5f7-5976-4839-9705-c1730ff6bf302026-03-25WarningsExact identifier
application number: M012
GOOD SENSE TUSSINACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINL. Perrigo Company5fb96638-a9bc-4be6-a624-da303a9e98a32026-03-25WarningsExact identifier
application number: M012
Cold and Flu Relief Multi symptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWinCo Foods, LLC9beeeb3b-6b26-4b9a-843b-ce3658d1debe2026-03-25WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefNIGHTTIME COLD AND FLU RELIEFGrocery Outleta58459e3-6ada-4d99-9e22-1a01076761512026-03-25WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MGGrocery Outlet2f90dfb6-4257-44a8-a685-1873645d1c962026-03-25WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEGrocery Outlet, Inc.4d887ed0-4532-5125-e063-6394a90ac44d2026-03-24WarningsExact identifier
application number: M012
DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS HEALTH CORP2ba90b91-2e35-4701-e063-6294a90a75542026-03-24WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESIN 400 MGTWIN MED LLCe31bd69f-97ab-9d99-e053-2995a90a580e2026-03-24WarningsExact identifier
application number: M012
Severe Sinus Congestion and Pain Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLBetter Living Brands, LLCb7b1c3cc-fdf3-4e75-8c3f-2e832f09a8872026-03-24WarningsExact identifier
application number: M012
Nuvicare Long-Acting Cough ReliefDEXTROMETHORPHAN HYDROBROMIDENUVICARE LLCec1d3dd6-2a8b-4487-81a2-be6313e976102026-03-24WarningsExact identifier
application number: M012
Cold and Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLCed28bfa9-3768-4f42-ae5e-1c527b4456d12026-03-24WarningsExact identifier
application number: M012
Gencare Long-Acting Cough ReliefDEXTROMETHORPHAN HYDROBROMIDEPIONEER LIFE SCIENCES, LLC7a02cbb6-c083-4d91-977b-9d53cb3e27842026-03-24WarningsExact identifier
application number: M012
Sinus Severe DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLCb65baa7c-8197-4361-b3ef-e60eba38dca12026-03-24WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreense9a53a2c-c5e8-48ba-97d9-c1e3cbd8da4b2026-03-24WarningsExact identifier
application number: M012
Mucus Relief Congestion and Headache Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2638b541-e680-4949-a7c7-fcee165cbc922026-03-23WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)778dc0fb-30c3-4fbf-856a-7bca28181b392026-03-23WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1857615Halls 6.4 MG Oral LozengePSNf5292c5b-5608-4e13-afc2-4f3d7133da883
1857613menthol 6.4 MG Oral LozengePSNf5292c5b-5608-4e13-afc2-4f3d7133da883
1857615menthol 6.4 MG Oral Lozenge [Halls]SBDf5292c5b-5608-4e13-afc2-4f3d7133da883
1857613menthol 6.4 MG Oral LozengeSCDf5292c5b-5608-4e13-afc2-4f3d7133da883
1857615Halls 6.4 MG Oral LozengeSYf5292c5b-5608-4e13-afc2-4f3d7133da883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12546-334-09125460334099 LOZENGE in 1 PACKAGE (12546-334-09) 9 lozenge2019-04-070000-00-00NoNoCurrent