Antiplaque solution

Product NDC: 53462-275
11-digit product format: 534620275
Labeler code: 53462
Product ID: 53462-275_5568ec99-5769-624a-e063-6294a90a7149
Type: HUMAN OTC DRUG
Nonproprietary name: CETYLPYRIDINIUM CHLORIDE
Dosage form: MOUTHWASH
Route: BUCCAL
Labeler: Sage Products LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-01-09
Substance: CETYLPYRIDINIUM CHLORIDE
Active strength: .5 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Antiplaque solution
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETYLPYRIDINIUM CHLORIDE	.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
D9OM4SK49P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1251617	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
881d4d08-4b45-486a-93af-18c0e00a5b0e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-02-22	Antiplaque Solution
2022-02-22	Antiplaque Solution
2022-02-22	Antiplaque Solution
2022-01-28	Antiplaque Solution
2022-01-28	Antiplaque Solution
2022-01-28	Antiplaque Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53462-275-60	Antiplaque solution	7 mL in 1 PACKET	MOUTHWASH	7		13
53462-275-60	QCare Oral Cleansing and Suctioning System, Q8	7 mL in 1 PACKET	MOUTHWASH	14 mL	0.5 mg in 1mL	11
53462-275-60	QCare Oral Cleansing and Suctioning System, Q4	7 mL in 1 PACKET	MOUTHWASH	14 mL	0.5 mg in 1mL	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
cetylpyridinium chloride	ACTIVE INGREDIENT	D9OM4SK49P	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	1
CETYLPYRIDINIUM CHLORIDE	ACTIVE INGREDIENT	D9OM4SK49P	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]	1
HYDROGEN PEROXIDE	ACTIVE INGREDIENT	BBX060AN9V	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]	1
cetylpyridinium	ACTIVE MOIETY	CUB7JI0JV3	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	1
CETYLPYRIDINIUM	ACTIVE MOIETY	CUB7JI0JV3	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]	1
HYDROGEN PEROXIDE	ACTIVE MOIETY	BBX060AN9V	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]	1
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]	1
peppermint	INACTIVE INGREDIENT	V95R5KMY2B	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	1
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]	1
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]	1
potassium sorbate	INACTIVE INGREDIENT	1VPU26JZZ4	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53462-275	ANTIPLAQUE SOLUTION (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [SAGE PRODUCTS LLC]	11	Current NDC, Legacy NDC, 1 package rows	20241116_881d4d08-4b45-486a-93af-18c0e00a5b0e.zip
53462-275	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q8 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]	11	Current NDC, Legacy NDC	20220223_f30104fd-7f9a-4db1-8006-36b5b6d7ddae.zip
53462-275	QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]	7	Current NDC, Legacy NDC	20180629_567bf599-4958-91c7-5c01-9c38a0d2da52.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 20 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topco Associates LLC Maximum Strength	FLUORIDE	Topco Associates LLC	ac398ff0-0010-4e13-8b89-dc986fd7f974	2025-08-08	Warnings	Exact identifier application number: M022
QUALITY CHOICE SALINE	PLUS SOOTHING ALOE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	4ae4e88a-aaa5-4195-bedc-622fd5cd9394	2025-07-30	Warnings	Exact identifier application number: M022
Aseptil Rojo	PHENOL	Menper Distributors, Inc.	62c96dc1-4698-43c1-8e6d-f4062dc5eea2	2025-07-22	Warnings	Exact identifier application number: M022
Anestenka	BENZOCAINE	Menper Distributors, Inc	00a3f1bc-ddfe-47c6-8221-f48f91513503	2025-07-22	Warnings	Exact identifier application number: M022
Cureforte Breath Reset	MOUTH SPRAY	STEEL CITY HEALTH PRIVATE LIMITED	38ddf1a7-29ab-cb8d-e063-6294a90ad34c	2025-07-21	Warnings	Exact identifier application number: M022
SprinJene Natural Sensitivity and Gum	POTASSIUM NITRATE	Health and Natural Beauty USA Corp	3cb23e36-0e8c-4172-b4ae-859b58a2739f	2025-07-07	Warnings	Exact identifier application number: M022
Normal Salt	SODIUM CHLORIDE	Twin Med LLC	dc82ff0f-8600-373a-e053-2995a90a7505	2025-07-03	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Kids Berry Twist	SODIUM FLUORIDE	Haleon US Holdings LLC	69c07c36-b5e0-420b-ab29-7d1091386322	2025-07-03	Warnings	Exact identifier application number: M022
DenTek Instant Pain Relief Maximum Strength	BENZOCAINE	DenTek Oral Care, Inc.	ae92b76e-815a-4b4c-8128-bd045098caa5	2025-06-30	Warnings	Exact identifier application number: M022
Sensodyne Clinical White Stain Protector	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	99037e59-53d6-492c-8fce-67641fc8efdd	2025-06-25	Warnings	Exact identifier application number: M022
Iolite-S	BENZOCAINE	Dharma Research, Inc.	b3b68914-2adc-4f07-9521-0b18756be522	2025-06-14	Warnings	Exact identifier application number: M022
Red Cross Toothache	EUGENOL	The Mentholatum Company	3537e599-65d9-48d6-8a46-d42312f71e84	2025-06-11	Warnings	Exact identifier application number: M022
QUALITY CHOICE Sore Throat	PHENOL	CHAIN DRUG MARKETING ASSOCIATION	c95ee086-f384-475d-ad0c-75518cb9d2fe	2025-06-10	Warnings	Exact identifier application number: M022
Onral Oral Pain Reliever Mouthwash	BENZOCAINE	Syka Pharma Inc.	5dd8d933-6f32-4eaf-8eca-9365d7de55a2	2025-06-03	Warnings	Exact identifier application number: M022
Orajel Rescue Relief Pen	ORAL PAIN RELIEVER	Church & Dwight Co., Inc.	2d68eec5-ae8a-9cdf-e063-6294a90a9799	2025-06-01	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	9e1f7462-a052-4db4-bc59-cce437b695d0	2025-05-20	Warnings	Exact identifier application number: M022
Saline 1.5 FL OZ	SALINE	ALAINA HEALTHCARE PRIVATE LIMITED	f1bdbb25-6943-4828-9ae0-7d9783c18b5f	2025-05-19	Warnings	Exact identifier application number: M022
Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry	FLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRY	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	3573f149-2af9-4c86-e063-6294a90a7b3f	2025-05-18	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Safeway, Inc.	8fe2f1df-3264-455d-b62c-953dce171c02	2025-05-16	Warnings	Exact identifier application number: M022
Parodontax Active Gum Health Daily Mouthwash Breath Freshener	CETYLPYRIDINIUM CHLORIDE	Haleon US Holdings LLC	32b632bf-058d-447b-a7fb-a9dd05c1e2b8	2025-05-08	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D9OM4SK49P	CETYLPYRIDINIUM CHLORIDE	6004-24-6	CETYLPYRIDINIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1251617	cetylpyridinium chloride 0.05 % Mouthwash	PSN	881d4d08-4b45-486a-93af-18c0e00a5b0e	13
1251617	cetylpyridinium chloride 0.5 MG/ML Mouthwash	SCD	881d4d08-4b45-486a-93af-18c0e00a5b0e	13
1251617	cetylpyridinium chloride 0.05 % Mouthwash	SY	881d4d08-4b45-486a-93af-18c0e00a5b0e	13
1251617	cetylpyridinium chloride 0.05 % Mouthwash	PSN	f30104fd-7f9a-4db1-8006-36b5b6d7ddae	11
358975	hydrogen peroxide 1.5 % Mouthwash	PSN	f30104fd-7f9a-4db1-8006-36b5b6d7ddae	11
1866540	Perox-A-Mint 1.5 % Mouthwash	PSN	f30104fd-7f9a-4db1-8006-36b5b6d7ddae	11
1866540	hydrogen peroxide 15 MG/ML Mouthwash [Perox-A-Mint]	SBD	f30104fd-7f9a-4db1-8006-36b5b6d7ddae	11
1251617	cetylpyridinium chloride 0.5 MG/ML Mouthwash	SCD	f30104fd-7f9a-4db1-8006-36b5b6d7ddae	11
358975	hydrogen peroxide 15 MG/ML Mouthwash	SCD	f30104fd-7f9a-4db1-8006-36b5b6d7ddae	11
1251617	cetylpyridinium chloride 0.05 % Mouthwash	SY	f30104fd-7f9a-4db1-8006-36b5b6d7ddae	11
358975	hydrogen peroxide 1.5 % Mouthwash	SY	f30104fd-7f9a-4db1-8006-36b5b6d7ddae	11
1866540	Perox-A-Mint 1.5 % Mouthwash	SY	f30104fd-7f9a-4db1-8006-36b5b6d7ddae	11
1866540	Perox-A-Mint 15 MG/ML Mouthwash	SY	f30104fd-7f9a-4db1-8006-36b5b6d7ddae	11
1251617	cetylpyridinium chloride 0.05 % Mouthwash	PSN	567bf599-4958-91c7-5c01-9c38a0d2da52	7
358975	hydrogen peroxide 1.5 % Mouthwash	PSN	567bf599-4958-91c7-5c01-9c38a0d2da52	7
1866540	Perox-A-Mint 1.5 % Mouthwash	PSN	567bf599-4958-91c7-5c01-9c38a0d2da52	7
1866540	hydrogen peroxide 15 MG/ML Mouthwash [Perox-A-Mint]	SBD	567bf599-4958-91c7-5c01-9c38a0d2da52	7
1251617	cetylpyridinium chloride 0.5 MG/ML Mouthwash	SCD	567bf599-4958-91c7-5c01-9c38a0d2da52	7
358975	hydrogen peroxide 15 MG/ML Mouthwash	SCD	567bf599-4958-91c7-5c01-9c38a0d2da52	7
1251617	cetylpyridinium chloride 0.05 % Mouthwash	SY	567bf599-4958-91c7-5c01-9c38a0d2da52	7
358975	hydrogen peroxide 1.5 % Mouthwash	SY	567bf599-4958-91c7-5c01-9c38a0d2da52	7
1866540	Perox-A-Mint 1.5 % Mouthwash	SY	567bf599-4958-91c7-5c01-9c38a0d2da52	7
1866540	Perox-A-Mint 15 MG/ML Mouthwash	SY	567bf599-4958-91c7-5c01-9c38a0d2da52	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53462-275-60	53462027560	7 mL in 1 PACKET (53462-275-60)	7 ml	2009-01-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Antiplaque Solution	Sage Products LLC	2026-06-29	HUMAN OTC DRUG LABEL	14
QCare Oral Cleansing and Suctioning System	Sage Products LLC	2022-02-22	HUMAN OTC DRUG LABEL	11
QCare Oral Cleansing and Suctioning System, Q4	Sage Products, LLC	2018-06-29	HUMAN OTC DRUG LABEL	7