FDA.reportPublic FDA data

Halls

Product NDC
12546-725
11-digit product format
125460725
Labeler code
12546
Product ID
12546-725_512a9a2e-6161-80d1-e063-6394a90aeff0
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
KIT
Route
ORAL
Labeler
Mondelez Global LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-20
NDC exclude flag
No
Listing certified through
2027-12-31
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
Variety Pack Mentholyptus Honey Lemon Cherry
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
476973Internal RxNorm lookup
485287Internal RxNorm lookup
896994Internal RxNorm lookup
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
512a9a2e-6160-80d1-e063-6394a90aeff0Available on FDA.report

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 91 of 174 · 3,464 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dimetapp Multi-Symptom Cold and FluACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEFoundation Consumer Healthcare178fe95b-e1ed-43b2-e063-6294a90a7a782025-10-24WarningsExact identifier
application number: M012
Menthol Drops Dollar General Severe 45ctMENTHOLDollar General Corporationc831d3d9-b910-40e6-bfdf-defe6850614d2025-10-24WarningsExact identifier
application number: M012
Cough Drops Dollar General Strawberry 30ctMENTHOLDollar General Corporation7d2f3292-bb73-41dc-9729-edb83670be1b2025-10-24WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol 30ctMENTHOLR.L. ALBERT & SON, INCb174e57c-4e4f-4842-b8f2-f1b067764a682025-10-24WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)17640528-c1f7-4881-ba86-bb3f488a952c2025-10-24WarningsExact identifier
application number: M012
Vapor StickCAMPHOR/MENTHOLChina Ningbo Shangge Cosmetics Technology Corp.33e259d6-b065-a677-e063-6394a90ab3142025-10-23WarningsExact identifier
application number: M012
Severe Nighttime Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy1ec3fc79-4f38-439f-99be-646b82231aa52025-10-23WarningsExact identifier
application number: M012
RycontussCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories, Inc41afb883-1158-9764-e063-6294a90a17122025-10-21WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBr, Chlorpheniramine MaleateACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATECVS Pharmacy, Inc1532ee21-e114-ded7-e063-6294a90ab0252025-10-21WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEMethod Pharmaceuticals1538bf63-d020-3ba2-e063-6294a90aecc52025-10-21WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEMethod Pharmaceuticals389230e5-775e-5b0d-e054-00144ff88e882025-10-21WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINMethod Pharmaceuticals, LLC1539c3d4-d982-7d4e-e063-6394a90ad7d62025-10-21WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINMethod Pharmaceuticals, LLC312ce620-4841-7488-e054-00144ff88e882025-10-21WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEMethod Pharmaceuticals, LLC5a60c923-8bb7-427f-9636-08ed5474f71b2025-10-21WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI311e2b6b-21cb-4b4c-a78d-a0732d29602f2025-10-21WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI13910ea1-37dd-43bb-9fe8-e843f59201b72025-10-21WarningsExact identifier
application number: M012
Quantum Health Bing Cherry FlavorMENTHOL, UNSPECIFIED FORMQuantum, Inc.94d40c95-fa2b-42cf-b9f5-a5027d86401d2025-10-20WarningsExact identifier
application number: M012
Quantum Health Meyer Lemon and Honey FlavorMENTHOL, UNSPECIFIED FORMQuantum, Inc.fe780067-5a20-4d55-a108-91237cd9e5f42025-10-20WarningsExact identifier
application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)DIPHENHYDRAMINE HCLMEDWISE LIFESCIENCES INC.4157e680-37ac-eb4c-e063-6394a90a2a992025-10-17WarningsExact identifier
application number: M012
Norel ADACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCLU.S. PHARMACEUTICAL CORPORATION53d9ed3c-212d-4b12-ac35-8bd49382b49d2025-10-17WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
12546-725-24125460725241 KIT in 1 KIT (12546-725-24) * 80 LOZENGE in 1 BAG (12546-109-80) * 80 LOZENGE in 1 BAG (12546-116-80) * 80 LOZENGE in 1 BAG (12546-110-80) 1 kit2026-07-20NoNoCurrent