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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	12546-352	12546-352-30	D	Discontinued by firm		2026-10-15

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 date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`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
Ingredient	Strength
PECTIN	7 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
89NA02M4RX	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
777fd6db-f129-4489-8312-4b1aca94878e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12546-352-25	BreezersCreamy Strawberry	25 in 1 BAG	LOZENGE	25	9
12546-352-30	BreezersCreamy Strawberry	30 in 1 BAG	LOZENGE	30	9
12546-352-70	BreezersCreamy Strawberry	70 in 1 BAG	LOZENGE	70	9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Pectin	ACTIVE INGREDIENT	89NA02M4RX	BREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]	1
Pectin	ACTIVE MOIETY	89NA02M4RX	BREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]	1
Beta Carotene	INACTIVE INGREDIENT	01YAE03M7J	BREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	BREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	BREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12546-352	BREEZERS CREAMY STRAWBERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]	9	Current NDC, Legacy NDC, 3 package rows	20241222_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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Iolite	BENZOCAINE	Dharma Research, Inc.	e4b2d22b-00b3-45a6-9b7d-8ee719587059	2023-10-09	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	a0e284f6-292f-4231-8596-f7cee4e0a12f	2023-10-09	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	fe92637a-c88a-f9dd-e053-6294a90a7fa3	2023-07-01	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	c979e958-2042-471a-bf03-e84e68620106	2023-06-20	Warnings	Exact identifier application number: M022
Orajel Gum Pain 3X Medicated	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	9a1632ad-2b47-5653-e053-2995a90ae0d9	2023-01-20	Warnings	Exact identifier application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINT	BENZOCAINE	DMG AMERICA, LLC	0f90b227-f938-4e1a-a79e-1967b1a0477e	2021-10-01	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
89NA02M4RX	PECTIN	9000-69-5	PECTIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1242251	Halls Breezers 7 MG Oral Lozenge	PSN	777fd6db-f129-4489-8312-4b1aca94878e	9
700897	pectin 7 MG Oral Lozenge	PSN	777fd6db-f129-4489-8312-4b1aca94878e	9
1242251	pectin 7 MG Oral Lozenge [Halls Breezers]	SBD	777fd6db-f129-4489-8312-4b1aca94878e	9
700897	pectin 7 MG Oral Lozenge	SCD	777fd6db-f129-4489-8312-4b1aca94878e	9
1242251	Halls Breezers 7 MG Oral Lozenge	SY	777fd6db-f129-4489-8312-4b1aca94878e	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12546-352-25	12546035225	25 LOZENGE in 1 BAG (12546-352-25)	25 lozenge	2019-03-13	0000-00-00	No	No	Current
12546-352-30	12546035230	30 LOZENGE in 1 BAG (12546-352-30)	30 lozenge	2019-03-13	0000-00-00	No	No	Current
12546-352-70	12546035270	70 LOZENGE in 1 BAG (12546-352-70)	70 lozenge	2021-05-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Halls Breezers creamy strawberry	Mondelez Global LLC \| Mondelez Canada Inc	2024-12-20	HUMAN OTC DRUG LABEL	9