Cloveden 100 times higher concentrated

Product NDC: 84516-040
11-digit product format: 845160040
Labeler code: 84516
Product ID: 84516-040_3c0e1862-2940-4d23-e063-6294a90a33e1
Type: HUMAN OTC DRUG
Nonproprietary name: Cetylpyridinium Chloride
Dosage form: MOUTHWASH
Route: ORAL
Labeler: Acuseplanet Inc
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-08-01
Substance: CETYLPYRIDINIUM CHLORIDE
Active strength: 2.29 g/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Cloveden 100 times higher concentrated
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETYLPYRIDINIUM CHLORIDE	2.29 g/100mL

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
2590919	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
3c0e1862-293f-4d23-e063-6294a90a33e1	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84516-040-01	Cloveden 100 times higher concentrated	50 mL in 1 BOTTLE	MOUTHWASH	50		1
84516-040-02	Cloveden 100 times higher concentrated	1 in 1 CARTON	MOUTHWASH	1		1

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 10 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
White Glo Purple Color Corrector Fluoride Anticavity	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	6f8b77c3-9833-4c75-b41c-a2bc12616157	2026-05-12	Warnings	Exact identifier application number: M021
botalab HERBAL COMPLETE TOOTH	SODIUM FLUORIDE	KMPHARMACEUTICAL CO., LTD.	51365ef7-ed94-2650-e063-6394a90ab89e	2026-05-07	Warnings	Exact identifier application number: M021
Morning Fresh Mint Toothpaste, with Fluoride	MORNING FRESH MINT TOOTHPASTE, WITH FLUORIDE	Dynarex Corporation	2a42d8ce-e7f2-caa5-e063-6294a90ac01f	2026-05-07	Warnings	Exact identifier application number: M021
Frida Fluoride Sweet Mint	SODIUM FLUORIDE	Fridababy, LLC	4f8b5a39-5d79-72cd-e063-6394a90a475c	2026-05-06	Warnings	Exact identifier application number: M021
Frida Fluoride Bubble Mint	SODIUM FLUORIDE	Fridababy, LLC	4f8b9af3-e4b3-b5e0-e063-6394a90a1068	2026-05-06	Warnings	Exact identifier application number: M021
Frida Fluoride Strawberry Toothbrush Set	SODIUM FLUORIDE	Fridababy, LLC	4f8ba14f-60ea-c2a8-e063-6394a90a7702	2026-05-06	Warnings	Exact identifier application number: M021
Frida Fluoride Strawberry	SODIUM FLUORIDE	Fridababy, LLC	4f814a62-8f91-8ea6-e063-6294a90a69eb	2026-05-06	Warnings	Exact identifier application number: M021
Gum Health Detoxify	STANNOUS FLUORIDE	Meijer, Inc	41d70733-a223-40fb-e063-6294a90a1397	2026-05-06	Warnings	Exact identifier application number: M021
Colgate Kids Unicorn Alcohol Free	SODIUM FLUORIDE	Colgate-Palmolive Company	133acaff-7205-80d7-e91d-3eb37087cae4	2026-05-05	Warnings	Exact identifier application number: M021
Crest 3D White Stain Eraser	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	fdefffbd-9c05-fa30-e053-6394a90a34bc	2026-05-05	Warnings	Exact identifier application number: M021
Frida Fluoride Watermelon	SODIUM FLUORIDE	Fridababy, LLC	4f8b49dc-e9e4-c341-e063-6294a90adb5a	2026-05-05	Warnings	Exact identifier application number: M021
White Glo Extreme White Whitening	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	4a2e0a8d-420e-4c07-aa43-386d05dab472	2026-04-30	Warnings	Exact identifier application number: M021
Equate Pro-Advanced TP Equate Pro-Advanced TP	STANNOUS FLUORIDE	Walmart Inc.	1e6561fb-4e3b-40ba-e063-6294a90a2690	2026-04-29	Warnings	Exact identifier application number: M021
Crest Cavity Protection Regular	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	852889b4-59ba-4592-b4fc-c0127a1ad075	2026-04-28	Warnings	Exact identifier application number: M021
Crest Complete Multi-Benefit Whitening plus Scope	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	0206710a-707f-4aa9-96b9-86240c1275dc	2026-04-28	Warnings	Exact identifier application number: M021
Alcohol Free Refreshing Mint	SODIUM FLUORIDE	H E B	cedf7c08-7412-4733-9b67-225b331cec8c	2026-04-27	Warnings, Adverse reactions	Exact identifier application number: M021
anzoon ANTIBACTERIAL MOUTH WASH	CETYLPYRIDINIUM CHLORIDE	Shandong AZC Biotechnology Co.,Ltd.	507c6896-2806-790c-e063-6394a90ac5ce	2026-04-27	Warnings	Exact identifier application number: M021
DELTA COMFORT PLUS AMENITY	SODIUM MONOFLUOROPHOSPHATE	Buzz Products Inc.	26434794-ae02-0f58-e063-6294a90ad85e	2026-04-24	Warnings	Exact identifier application number: M021
A and H Plus Therabreath Breath Freshners	SODIUM FLUORIDE	Church & Dwight Co., Inc.	18d6073e-b1ee-47d2-9758-2cf04f3cf3ca	2026-04-23	Warnings	Exact identifier application number: M021
Fluoride	SODIUM FLUORIDE	McKesson	5025e58e-e59c-07b6-e063-6394a90ac1e8	2026-04-23	Warnings	Exact identifier application number: M021

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
2590919	cetylpyridinium chloride 2.3 % Concentrated Mouthwash	PSN	3c0e1862-293f-4d23-e063-6294a90a33e1	1
2590919	cetylpyridinium chloride 23 MG/ML Mouthwash	SCD	3c0e1862-293f-4d23-e063-6294a90a33e1	1
2590919	cetylpyridinium chloride 2.296 % Mouthwash	SY	3c0e1862-293f-4d23-e063-6294a90a33e1	1
2590919	cetylpyridinium chloride 2.3 % Mouthwash	SY	3c0e1862-293f-4d23-e063-6294a90a33e1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84516-040-01	84516004001	50 mL in 1 BOTTLE	50 ml				Historical
84516-040-02	84516004002	1 BOTTLE in 1 CARTON (84516-040-02) / 50 mL in 1 BOTTLE (84516-040-01)	1 bottle	2025-08-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetylpyridinium Chloride - Acuseplanet Inc \| DONG IL PHARMS CO., LTD.	Acuseplanet Inc \| DONG IL PHARMS CO., LTD.	2025-08-10	HUMAN OTC DRUG LABEL	1