FDA.reportPublic FDA data

Breezers

Product NDC
12546-352
11-digit product format
125460352
Labeler code
12546
Product ID
12546-352_29b53120-8950-68b8-e063-6394a90aaeb0
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
2016-08-03
Substance
PECTIN
Active strength
7 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage12546-35212546-352-30DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
Breezers
Brand name suffix
Creamy Strawberry
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
777fd6db-f129-4489-8312-4b1aca94878eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-352-25BreezersCreamy Strawberry25 in 1 BAGLOZENGE259
12546-352-30BreezersCreamy Strawberry30 in 1 BAGLOZENGE309
12546-352-70BreezersCreamy Strawberry70 in 1 BAGLOZENGE709

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PectinACTIVE INGREDIENT89NA02M4RXBREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
PectinACTIVE MOIETY89NA02M4RXBREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
Beta CaroteneINACTIVE INGREDIENT01YAE03M7JBREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62BREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554BREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RBREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-352BREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]9Current NDC, Legacy NDC, 3 package rows20241222_777fd6db-f129-4489-8312-4b1aca94878e.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 22 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEWinCo Foods, LLC9417b340-942b-48bf-bbfd-4cd5154082b92025-02-12WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCb291811f-8fac-45e2-a9a2-b3ecc0813d0d2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCfea30599-5e3b-4163-9660-d41b3fcee1432025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC3be68966-199c-481e-8b9e-e994c41fd96a2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCccdee0cc-2bc9-4165-a411-02f4f900d86a2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC0ca2b042-ea2c-4cbe-ae68-5a72a6bfa0b72025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC69c4dd1b-a0db-4495-bfc3-faffdfdf59bf2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCd5ef3e65-35e8-4323-9f33-3076b561e1052025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC746df21c-e92e-4a71-b1c6-baf99785a43e2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC2345e614-c7b6-448c-8e07-31700bade91c2025-01-29WarningsExact identifier
application number: M022
UltraCare Anesthetic GelBENZOCAINEThe Belport Company, Inc. DBA Gingi-Pak142062ca-6f8f-78d2-e063-6294a90a19d82025-01-29Warnings, Adverse reactionsExact identifier
application number: M022
CHLORASEPTIC MAXMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.edd12a2d-aa27-4f15-9ce6-862e4b6144c42025-01-23WarningsExact identifier
application number: M022
meijer Sensitive FRESH MINTPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.bea36d55-1a5d-40c0-b422-92fb36043ee62025-01-23WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC159d412c-6d1a-45d4-88c0-8c93960f946e2025-01-21WarningsExact identifier
application number: M022
SEACALL MouthwashMOUTHWASHGuangdong Quadrant Ecological Technology Co., Ltd.2c1a7eed-6a7c-eeb2-e063-6394a90aafcc2025-01-19WarningsExact identifier
application number: M022
BENZOCAINE RaspberryBENZOCAINEDarby Dental Supply, LLCdd805400-26c5-4c18-ade2-821298233f9b2025-01-17WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCc68fd8c7-7ec3-cc3f-e053-2995a90a43952025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.d22f7776-1b3c-4744-bcfe-8d9597218d732025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.9c6a26e8-1253-49f7-9ce2-45c0d39f05c52025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.48178733-7433-41ec-b178-1314e0edab1a2025-01-16WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1242251Halls Breezers 7 MG Oral LozengePSN777fd6db-f129-4489-8312-4b1aca94878e9
700897pectin 7 MG Oral LozengePSN777fd6db-f129-4489-8312-4b1aca94878e9
1242251pectin 7 MG Oral Lozenge [Halls Breezers]SBD777fd6db-f129-4489-8312-4b1aca94878e9
700897pectin 7 MG Oral LozengeSCD777fd6db-f129-4489-8312-4b1aca94878e9
1242251Halls Breezers 7 MG Oral LozengeSY777fd6db-f129-4489-8312-4b1aca94878e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12546-352-251254603522525 LOZENGE in 1 BAG (12546-352-25) 25 lozenge2019-03-130000-00-00NoNoCurrent
12546-352-301254603523030 LOZENGE in 1 BAG (12546-352-30) 30 lozenge2019-03-130000-00-00NoNoCurrent
12546-352-701254603527070 LOZENGE in 1 BAG (12546-352-70) 70 lozenge2021-05-110000-00-00NoNoCurrent