HALLS

Product NDC
12546-722
11-digit product format
125460722
Labeler code
12546
Product ID
12546-722_396f93a9-8d2d-2f27-e063-6294a90ab344
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
2025-10-15
Substance
MENTHOL
Active strength
18 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
Extra Strong
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL18 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
1422187Internal RxNorm lookup
1422189Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
396f93a9-8d2c-2f27-e063-6294a90ab344Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-722-09HALLSExtra Strong9 in 1 PACKAGELOZENGE91

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 82 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Cold and CoughASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.75862805-2cfe-fb45-e053-2991aa0a14032025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5172dc01-4e7f-3307-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid GelsACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.20ae92d9-fbc6-5b7a-e063-6294a90a15c32025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51c44970-06e5-082e-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.54236151-37db-0b5a-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.52542774-fd05-640c-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51dca689-e4a0-5526-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.6f2d18f6-935f-9215-e053-2a91aa0aedd32025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTRMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.6fb28fa1-ebbb-64bf-e053-2991aa0a1de42025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5213ca7f-5a78-6471-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.6f7ba256-ed14-5fe0-e053-2a91aa0aacc12025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.6f7bf92d-4aaf-86e0-e053-2991aa0a2d912025-12-04WarningsExact identifier
application number: M012
Afrin NoDrip Allergy Sinus NightOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.b023a571-7e54-7c63-e053-2a95a90a0f782025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDEBayer HealthCare LLC.b1cd7d9f-0ab4-21ce-e053-2a95a90a8c3d2025-12-04WarningsExact identifier
application number: M012
Children Afrin No Drip Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.e3231869-8ddf-9d17-e053-2995a90ae6d52025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Maximum Strength Multi Symptom FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.ae7cf41e-b618-d6bb-e053-2a95a90a66922025-12-04WarningsExact identifier
application number: M012
Afrin Allergy Sinus NasalOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.c2d903bf-5c51-82d7-e053-2995a90aea492025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Maximum Strength Cold, Cough and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.351d3c5c-05c8-921a-e063-6394a90abef92025-12-04WarningsExact identifier
application number: M012
Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.e3b239bd-ffc7-600c-e053-2a95a90a3b3b2025-12-04WarningsExact identifier
application number: M012
Coricidin HBP Maximum Strength Cold Flu And Chest CongestionACETAMINOPHEN, GUAIFENESINBayer HealthCare LLC.de95d2dd-e766-f7ec-e053-2995a90afc5f2025-12-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1422189Halls 18 MG Oral LozengePSN396f93a9-8d2c-2f27-e063-6294a90ab3441
1422187Menthol 18 MG Oral LozengePSN396f93a9-8d2c-2f27-e063-6294a90ab3441
1422189menthol 18 MG Oral Lozenge [Halls]SBD396f93a9-8d2c-2f27-e063-6294a90ab3441
1422187menthol 18 MG Oral LozengeSCD396f93a9-8d2c-2f27-e063-6294a90ab3441
1422189Halls 18 MG Oral LozengeSY396f93a9-8d2c-2f27-e063-6294a90ab3441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
12546-722-09125460722099 LOZENGE in 1 PACKAGE (12546-722-09) 9 lozenge2025-10-15NoNoCurrent