FDA.reportPublic FDA data

Halls

Product NDC
12546-720
11-digit product format
125460720
Labeler code
12546
Product ID
12546-720_29b54da8-f685-6907-e063-6394a90a3061
Type
HUMAN OTC DRUG
Nonproprietary name
Pectin
Dosage form
LOZENGE
Route
ORAL
Labeler
Mondelez Global LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-27
Substance
PECTIN
Active strength
7 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
Breezers Sugar Free Cool Berry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PECTIN7 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89NA02M4RXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
700897Internal RxNorm lookup
1242251Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dd1b4b17-4f73-4052-9589-d5fd6bb059bbAvailable 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
12546-720-20HallsBreezers Sugar Free Cool Berry20 in 1 BAGLOZENGE207

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PectinACTIVE INGREDIENT89NA02M4RXHALLS BREEZERS SUGAR FREE COOL BERRY (PECTIN) LOZENGE [KRAFT FOODS GLOBAL, INC.]2
PectinACTIVE MOIETY89NA02M4RXHALLS BREEZERS SUGAR FREE COOL BERRY (PECTIN) LOZENGE [KRAFT FOODS GLOBAL, INC.]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9HALLS BREEZERS SUGAR FREE COOL BERRY (PECTIN) LOZENGE [KRAFT FOODS GLOBAL, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHALLS BREEZERS SUGAR FREE COOL BERRY (PECTIN) LOZENGE [KRAFT FOODS GLOBAL, INC.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1HALLS BREEZERS SUGAR FREE COOL BERRY (PECTIN) LOZENGE [KRAFT FOODS GLOBAL, INC.]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311HALLS BREEZERS SUGAR FREE COOL BERRY (PECTIN) LOZENGE [KRAFT FOODS GLOBAL, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHALLS BREEZERS SUGAR FREE COOL BERRY (PECTIN) LOZENGE [KRAFT FOODS GLOBAL, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHALLS BREEZERS SUGAR FREE COOL BERRY (PECTIN) LOZENGE [KRAFT FOODS GLOBAL, INC.]2
ISOMALTINACTIVE INGREDIENTS870P55O2WHALLS BREEZERS SUGAR FREE COOL BERRY (PECTIN) LOZENGE [KRAFT FOODS GLOBAL, INC.]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62HALLS BREEZERS SUGAR FREE COOL BERRY (PECTIN) LOZENGE [KRAFT FOODS GLOBAL, INC.]2
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPHALLS BREEZERS SUGAR FREE COOL BERRY (PECTIN) LOZENGE [KRAFT FOODS GLOBAL, INC.]2
MALTITOLINACTIVE INGREDIENTD65DG142WKHALLS BREEZERS SUGAR FREE COOL BERRY (PECTIN) LOZENGE [KRAFT FOODS GLOBAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHALLS BREEZERS SUGAR FREE COOL BERRY (PECTIN) LOZENGE [KRAFT FOODS GLOBAL, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RHALLS BREEZERS SUGAR FREE COOL BERRY (PECTIN) LOZENGE [KRAFT FOODS GLOBAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-720HALLS BREEZERS SUGAR FREE COOL BERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]7Current NDC, Legacy NDC, 1 package rows20241222_dd1b4b17-4f73-4052-9589-d5fd6bb059bb.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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1242251Halls Breezers 7 MG Oral LozengePSNdd1b4b17-4f73-4052-9589-d5fd6bb059bb7
700897pectin 7 MG Oral LozengePSNdd1b4b17-4f73-4052-9589-d5fd6bb059bb7
1242251pectin 7 MG Oral Lozenge [Halls Breezers]SBDdd1b4b17-4f73-4052-9589-d5fd6bb059bb7
700897pectin 7 MG Oral LozengeSCDdd1b4b17-4f73-4052-9589-d5fd6bb059bb7
1242251Halls Breezers 7 MG Oral LozengeSYdd1b4b17-4f73-4052-9589-d5fd6bb059bb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12546-720-201254607202020 LOZENGE in 1 BAG (12546-720-20) 20 lozenge2019-05-270000-00-00NoNoCurrent