FDA.reportPublic FDA data

Halls

Product NDC
12546-720
11-digit product format
125460720
Labeler code
12546
Product ID
12546-720_c3a49400-e5af-4947-9705-12cc6b0f4b4b
Type
HUMAN OTC DRUG
Nonproprietary name
Pectin
Dosage form
LOZENGE
Route
ORAL
Labeler
Mondelez Global LLC
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-05-27
Marketing end
0000-00-00
Substance
PECTIN
Active strength
7 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct12546-720DDiscontinued by firm2026-11-13
excluded packagepackage12546-72012546-720-20DDiscontinued by firm2026-11-13

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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]7Legacy NDC, 1 package rows20241222_dd1b4b17-4f73-4052-9589-d5fd6bb059bb.zip

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