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		2026-10-15

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: 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 23 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	af430cf4-f1b4-4b57-b8e3-87df96d655d3	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	2b089fec-cae3-4dc9-964d-d37f732a2f9f	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	6c137a93-4a34-4849-997f-bd0c572466ef	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	e8aa9709-e8f6-47a6-ab29-1fef2309786b	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	8c55b39c-8231-46a1-92ef-9fb4e3f40c1e	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	9e82dc54-aeca-457f-b4b9-2f18cc269538	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	1a8f5964-770a-4d14-a7b6-18b5da9159b0	2025-01-16	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d722cdf3-7671-eb27-e053-2a95a90a09c4	2025-01-16	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d722bf24-ae85-54f6-e053-2995a90a1d35	2025-01-16	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d721864d-0950-8379-e053-2a95a90a3bcb	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	b0e5dc67-da7a-42ac-8657-e8e4da6914be	2025-01-16	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d721ff57-0111-4bbb-e053-2995a90a1a70	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	8129e871-5f31-4138-ae47-f8978fa6287f	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	0301c1bc-db48-4635-97f5-9eaef7ab9579	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	c0c88180-ccdc-4c48-b262-3ec20d4775d4	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	ba011795-6822-4fff-b9c8-5c91cf9972a7	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb	2025-01-16	Warnings	Exact identifier application number: M022
Defend	BENZOCAINE	Mydent International	462a5f09-131f-4dfa-a502-547c44e4a4a5	2025-01-16	Warnings	Exact identifier application number: M022
Benzocaine	TOPICAL ANESTHETIC	Everpharm LLC	2bc57111-0f15-b237-e063-6294a90a4471	2025-01-15	Warnings	Exact identifier application number: M022
Kanka Triple Action	BENZOCAINE AND MENTHOL, UNSPECIFIED FORM	Blistex Inc.	078fcdab-38a1-4a9a-bdd3-e17446591ea8	2025-01-09	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