Halls

Product NDC
12546-320
11-digit product format
125460320
Labeler code
12546
Product ID
12546-320_37b45686-b73a-5d88-e063-6394a90af12a
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
8.8 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
Honey Lemon
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL8.8 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
1811174Internal RxNorm lookup
1811176Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
25eaae85-d516-40da-a472-70736ea2b75dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-320-09HallsHoney Lemon9 in 1 PACKAGELOZENGE94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-320HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]3Current NDC, Legacy NDC, 1 package rows20240627_25eaae85-d516-40da-a472-70736ea2b75d.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 118 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HISTEX-DM New FormulationDEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCIAllegis Pharmaceuticals, LLC30010401-e5b4-2bd9-e063-6394a90a0b0b2025-03-10WarningsExact identifier
application number: M012
daytime severe cold multi-symptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIcc7c5f1c-76b7-4278-8e2a-5fbc85e022dd2025-03-08WarningsExact identifier
application number: M012
Cold and Head Congestion Relief SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWinCo Foods, LLCa39778ba-1f63-4495-8e9b-44b0bdd7f71a2025-03-08WarningsExact identifier
application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat DayACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC2e9540e4-bd1d-9370-e063-6294a90affcb2025-03-07WarningsExact identifier
application number: M012
Herbal Cough Drops Original HerbCOUGH DROPSTopco Associates LLC2fb22181-aee3-d0bf-e063-6294a90a78652025-03-06WarningsExact identifier
application number: M012
REVASOL DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERnv LLC2f9ddcc3-b913-f8b0-e063-6294a90a93ab2025-03-05WarningsExact identifier
application number: M012
Herbal Throat Drops Lemon Mint HerbTHROAT DROPSTopco Associates LLC2fa086b4-3b0e-0df8-e063-6294a90a67692025-03-05WarningsExact identifier
application number: M012
Redicare Nasal and Sinus DecongestantREDICARE NASAL AND SINUS DECONGESTANTRedicare LLC2f24be68-f30e-d916-e063-6294a90a7e312025-03-04WarningsExact identifier
application number: M012
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HCL ORAL SOLUTIONKesin Pharma Corporation2f871005-de4d-8b2a-e063-6394a90aa43a2025-03-04WarningsExact identifier
application number: M012
CVS Daytime Cough Relief Chews - Citrus PunchDEXTROMETHORPHAN HBRCVS2f885f1b-7ff5-251b-e063-6394a90a656f2025-03-04WarningsExact identifier
application number: M012
CVS Dex-Dox Kids Nighttime Cough SuppressantDEXTROMETHORPHAN HBRCVS2f8b6f5e-399c-b033-e063-6294a90ac3d12025-03-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCff8b096c-8f01-4a8c-a98f-e4aa4d688e952025-03-04WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Vanilla FlavorMENTHOL7-ELEVEN2f3c43dd-175f-722e-e063-6294a90acff92025-02-28WarningsExact identifier
application number: M012
Menthol Cough Drops Creamy Strawberry FlavorMENTHOL AND PECTIN7-ELEVEN2f3c3c65-4178-6304-e063-6294a90a51fa2025-02-28WarningsExact identifier
application number: M012
Menthol Cough Drops Creamy Strawberry FlavorMENTHOL AND PECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.2efbffd7-bbdd-c5f5-e063-6294a90a15f02025-02-25WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Vanilla FlavorMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2efc46c9-a421-1998-e063-6394a90aeb642025-02-25WarningsExact identifier
application number: M012
Redicare Cough Drops Cherry FlavoredCHERRY FLAVORED MENTHOL COUGH DROPSRedicare LLC2efeaafa-ee96-37ee-e063-6394a90a9a4b2025-02-25WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLGenexa Inc.e880b8d7-61c3-41cc-e053-2995a90aaaeb2025-02-20WarningsExact identifier
application number: M012
Gencare-Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLC596ec923-56a0-4b6e-a69c-8d740feb75a22025-02-20WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-packACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC77a2dc96-73ee-4ca2-b1fe-4069958026062025-02-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1811176Halls 8.8 MG Oral LozengePSN25eaae85-d516-40da-a472-70736ea2b75d4
1811174menthol 8.8 MG Oral LozengePSN25eaae85-d516-40da-a472-70736ea2b75d4
1811176menthol 8.8 MG Oral Lozenge [Halls]SBD25eaae85-d516-40da-a472-70736ea2b75d4
1811174menthol 8.8 MG Oral LozengeSCD25eaae85-d516-40da-a472-70736ea2b75d4
1811176Halls 8.8 MG Oral LozengeSY25eaae85-d516-40da-a472-70736ea2b75d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12546-320-09125460320099 LOZENGE in 1 PACKAGE (12546-320-09) 9 lozenge2019-03-240000-00-00NoNoCurrent