DuoCare Clinical Oral Rinse

Product NDC: 53329-030
11-digit product format: 533290030
Labeler code: 53329
Product ID: 53329-030_40d1c70d-8f8c-2334-e063-6394a90a4d35
Type: HUMAN OTC DRUG
Nonproprietary name: Cetylpyridinium Chloride
Dosage form: MOUTHWASH
Route: DENTAL
Labeler: Medline Industries, LP
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-11-01
Substance: CETYLPYRIDINIUM CHLORIDE
Active strength: 1 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: DuoCare Clinical Oral Rinse
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETYLPYRIDINIUM CHLORIDE	1 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1291375	Internal RxNorm lookup
2264796	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
98e61cd5-7e29-7066-e053-2a95a90afa21	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-030-07	DuoCare Clinical Oral Rinse	7 mL in 1 POUCH	MOUTHWASH	7		8
53329-030-13	DuoCare Clinical Oral Rinse	59 mL in 1 BOTTLE	MOUTHWASH	59		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-030	DUOCARE CLINICAL ORAL RINSE (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MEDLINE INDUSTRIES, LP]	8	Current NDC, Legacy NDC, 2 package rows	20231017_98e61cd5-7e29-7066-e053-2a95a90afa21.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 16 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GuruNanda Oxyfusion	HYDROGEN PEROXIDE	GURUNANDA, LLC	3be317b9-a5d8-b198-e063-6394a90af985	2025-11-11	Warnings	Exact identifier application number: M022
GuruNanda Oral Pain Relief	MENTHOL	GURUNANDA, LLC	3b8f3562-0e46-bea4-e063-6294a90adb71	2025-11-11	Warnings	Exact identifier application number: M022
TopCare Cherry Flavor	PHENOL	TOPCO ASSOCIATES, LLC	5d3f0610-deb4-4180-ae19-2c65ed2f368b	2025-11-10	Warnings	Exact identifier application number: M022
Topcare Sore Throat Menthol Flavor	PHENOL	TOPCO ASSOCIATES LLC	fb1f2c11-2508-4985-bae5-7d547bd6aa23	2025-11-10	Warnings	Exact identifier application number: M022
Zilactin-B	BENZOCAINE	ASCENT CONSUMER PRODUCTS, INC	42eeb3d4-bac6-4e29-e063-6294a90a644d	2025-11-06	Warnings	Exact identifier application number: M022
Zilactin Early Relief Cold Sore	BENZYL ALCOHOL	ASCENT CONSUMER PRODUCTS, INC	42ef8bfa-c4d9-01cf-e063-6394a90ac88a	2025-11-06	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Gel	BENZOCAINE	Beutlich Pharmaceuticals, LLC	106b6115-d043-4050-80c6-1d82456dea02	2025-11-06	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Gel	BENZOCAINE	Beutlich Pharmaceuticals, LLC	4c278122-2643-46bf-9e44-11985210a16e	2025-11-06	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	fee9969d-ad1a-4f44-9741-a0a44c9e1128	2025-11-06	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	Target Corporation	0ddf9945-147d-4b25-98a6-4e9f12a4656f	2025-11-05	Warnings	Exact identifier application number: M022
Alpha-Caine Topical Anesthetic	BENZOCAINE	Dental Technologies, Inc.	e6a312e5-17ac-46f0-8723-4e40eeecd69f	2025-11-04	Warnings	Exact identifier application number: M022
PEROXY SHIELD MOUTH SORE	1.5% HYDROGEN PEROXIDE	Dental Technologies, Inc.	a72e433b-1b7d-4a0c-e053-2995a90a30c4	2025-11-04	Warnings	Exact identifier application number: M022
Alpha-Caine Topical Anesthetic	BENZOCAINE	Dental Technologies, Inc.	ae628766-25b7-4b4f-abb8-a43faf2f44b9	2025-11-04	Warnings	Exact identifier application number: M022
Alpha-Caine Topical Anesthetic	BENZOCAINE	Dental Technologies, Inc.	719743f9-21fc-4568-b879-acdfa4639464	2025-11-04	Warnings	Exact identifier application number: M022
Alpha-Caine Topical Anesthetic	BENZOCAINE	Dental Technologies, Inc.	ff0695a1-1d7d-4b51-97fd-689e56d914fe	2025-11-04	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Family Dollar (FAMILY WELLNESS)	f7edf75c-cdba-4dde-bfc5-a04af34759d3	2025-11-03	Warnings	Exact identifier application number: M022
7 Select Oral Pain Maximum Strength Relief	BENZOCAINE	7-ELEVEN, INC.	f170a570-1c50-4b9a-be16-9b01bf5eaa74	2025-10-31	Warnings	Exact identifier application number: M022
Oral Pain Relief	BENZOCAINE AND BENZALKONIUM CHLORIDE	Universal Distribution Center LLC	18520f9b-4d35-1e9c-e063-6294a90aaa39	2025-10-30	Warnings	Exact identifier application number: M022
Iodent Oral Analgesic	BENZOCAINE	United Exchange Corp.	63902125-f8dc-0ada-e053-2991aa0a7ce5	2025-10-30	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	BETTER LIVING BRANDS, LLC	3bded237-4d2c-4b38-bedc-267fdc374194	2025-10-29	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
1291375	cetylpyridinium chloride 0.1 % Mouthwash	PSN	98e61cd5-7e29-7066-e053-2a95a90afa21	8
2264796	DuoCare Clinical 0.1 % Mouthwash	PSN	98e61cd5-7e29-7066-e053-2a95a90afa21	8
2264796	cetylpyridinium chloride 1 MG/ML Mouthwash [DuoCare Clinical]	SBD	98e61cd5-7e29-7066-e053-2a95a90afa21	8
1291375	cetylpyridinium chloride 1 MG/ML Mouthwash	SCD	98e61cd5-7e29-7066-e053-2a95a90afa21	8
1291375	cetylpyridinium chloride 0.1 % Mouthwash	SY	98e61cd5-7e29-7066-e053-2a95a90afa21	8
2264796	DuoCare Clinical 0.1 % Mouthwash	SY	98e61cd5-7e29-7066-e053-2a95a90afa21	8
2264796	DuoCare Clinical 1 MG/ML Mouthwash	SY	98e61cd5-7e29-7066-e053-2a95a90afa21	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-030-07	53329003007	7 mL in 1 POUCH (53329-030-07)	7 ml	2018-11-01	0000-00-00	No	No	Current
53329-030-13	53329003013	59 mL in 1 BOTTLE (53329-030-13)	59 ml	2018-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
030 DuoCare™ Clinical Oral Rinse	Medline Industries, LP	2025-10-10	HUMAN OTC DRUG LABEL	9
IIMED DUOCARE CLINICAL ORAL RINSE	IIMED MEDICAL MEXICANA S DE RL DE CV \| Team Technologies	2023-10-20	HUMAN OTC DRUG LABEL	2