Breezers

Product NDC: 12546-151
11-digit product format: 125460151
Labeler code: 12546
Product ID: 12546-151_29b4ca83-7407-7065-e063-6394a90a30ef
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: 2019-03-24
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	12546-151	12546-151-30	D	Discontinued by firm		2026-10-12

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: Cool Berry
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
700897	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
b31d0078-21d7-4d18-a8d3-7c8d48d6d004	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12546-151-25	BreezersCool Berry	25 in 1 BAG	LOZENGE	25	7
12546-151-30	BreezersCool Berry	30 in 1 BAG	LOZENGE	30	7
12546-151-70	BreezersCool Berry	70 in 1 BAG	LOZENGE	70	7

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12546-151	BREEZERS COOL BERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]	7	Current NDC, Legacy NDC, 3 package rows	20241222_b31d0078-21d7-4d18-a8d3-7c8d48d6d004.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 11 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Kids Advanced Color Changing	SODIUM MONOFLUOROPHOSPHATE	Procter & Gamble Manufactura, S de R.L. de C.V.	fc86b98e-d556-4769-e053-6394a90afc6e	2026-01-08	Warnings	Exact identifier application number: M022
Care One Maximum Strength	FLUORIDE	American Sales	1b6618ea-6533-41d7-be2c-13bb9e108dc5	2026-01-08	Warnings	Exact identifier application number: M022
equate Sensitive	POTASSIUM NITRATE, SODIUM FLUORIDE	Wal-Mart Stores Inc	79899b59-3a16-6504-e053-2991aa0a895a	2026-01-08	Warnings	Exact identifier application number: M022
Crest Kids Advanced Color Changing	SODIUM MONOFLUOROPHOSPHATE	Procter & Gamble Manufactura, S de R.L. de C.V.	451283d3-78b0-8361-e063-6294a90a1fd5	2026-01-08	Warnings	Exact identifier application number: M022
CVS Maximum Strength	BENZOCAINE	CVS Pharmacy	8691d6b6-741e-47b2-8332-76742b34715f	2026-01-08	Warnings	Exact identifier application number: M022
4x Medicated Toothache and Gum Gel	BENZOCAINE	Publix Super Markets INC	16eb9d15-dba3-36e6-e063-6394a90ab859	2026-01-08	Warnings	Exact identifier application number: M022
Toothache and Gum Relief	BENZOCAINE, MENTHOL	CVS Pharmacy	814ec7bf-f825-1095-e053-2a91aa0aee59	2026-01-08	Warnings	Exact identifier application number: M022
Lemon	GLYCERIN	Sion Biotext Medical Ltd	dbd7ed86-1b92-4471-827a-89f3afa1b0dc	2026-01-08	Warnings	Exact identifier application number: M022
Sootheez Organic Wild Cherry	PECTIN	BFY LLC	47baa2a8-270c-fa07-e063-6394a90a97f6	2026-01-06	Warnings	Exact identifier application number: M022
Parodontax Gum Strengthen and Protect	CETYLPYRIDINIUM CHLORIDE	Haleon US Holdings LLC	3bb378c8-14b2-aa13-e063-6294a90a4db3	2026-01-05	Warnings	Exact identifier application number: M022
MySweetSmile Toothpaste.	MYSWEETSMILE TOOTHPASTE.	Jiangxi Dentalbright Technology Co., Ltd	478baf87-9276-7288-e063-6294a90a9e8e	2026-01-04	Warnings	Exact identifier application number: M022
MySweetSmile Mango Toothpaste.	MYSWEETSMILE MANGO TOOTHPASTE.	Jiangxi Dentalbright Technology Co., Ltd	478cbdeb-28e1-fa56-e063-6294a90af124	2026-01-04	Warnings	Exact identifier application number: M022
Smile Paint	SODIUM FLUORIDE	JABBER JAW KIDS TOOTHPASTE LLC	a7463b5c-53b2-4353-a5ea-800fbd7bd17d	2026-01-02	Warnings	Exact identifier application number: M022
Dentek Canker Cover	MENTHOL	Bershtel Enterprises	2669183c-7a58-037e-e054-00144ff88e88	2025-12-31	Warnings	Exact identifier application number: M022
AutoBrush strawberry	SODIUM FLUORIDE	Lander Enterprises, LLC	05929148-bffe-439f-a9d4-3170816c0fa2	2025-12-31	Warnings	Exact identifier application number: M022
AutoBrush Watermelon	SODIUM FLUORIDE	Lander Enterprises, LLC	37a4e712-e3b5-42f6-971c-98dea4b8dd06	2025-12-31	Warnings	Exact identifier application number: M022
AutoBrush Mint	SODIUM FLUORIDE	Lander Enterprises, LLC	6bcd35f5-18ea-4fc8-84cd-06db73f38a1e	2025-12-31	Warnings	Exact identifier application number: M022
AutoBrush Bubblegum	SODIUM FLUORIDE	Lander Enterprises, LLC	e7bf7e31-650d-4a1c-9100-48722344b201	2025-12-31	Warnings	Exact identifier application number: M022
Normal Salt	SODIUM CHLORIDE	GRAXCELL PHARMACEUTICAL, LLC	f3f09817-8a38-4aa1-956b-69d9cf695074	2025-12-25	Warnings	Exact identifier application number: M022
Sensitive Mint Tooth-paste	POTASSIUM NITRATE, SODIUM FLUORIDE	Meijer, Inc.	1e5e8b24-8304-482c-ae80-73effcc345da	2025-12-23	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
700897	pectin 7 MG Oral Lozenge	PSN	b31d0078-21d7-4d18-a8d3-7c8d48d6d004	7
700897	pectin 7 MG Oral Lozenge	SCD	b31d0078-21d7-4d18-a8d3-7c8d48d6d004	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12546-151-25	12546015125	25 LOZENGE in 1 BAG (12546-151-25)	25 lozenge	2019-03-24	0000-00-00	No	No	Current
12546-151-30	12546015130	30 LOZENGE in 1 BAG (12546-151-30)	30 lozenge	2019-03-24	0000-00-00	No	No	Current
12546-151-70	12546015170	70 LOZENGE in 1 BAG (12546-151-70)	70 lozenge	2019-03-24	0000-00-00	No	No	Current