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 8 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Premium Plus Scope Active Foam plus Whitening Dualblast Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5500f9ab-b0c4-51d6-e063-6394a90acd38	2026-06-24	Warnings	Exact identifier application number: M021
Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5504ec96-aae1-f5f9-e063-6294a90ad8bb	2026-06-24	Warnings	Exact identifier application number: M021
COLGATE SPARKLING WHITE CINNAMINT	SODIUM FLUORIDE	Colgate-Palmolive Company	f2ff18d2-4ef0-454e-a6f1-6f3bf361c7d1	2026-06-24	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	54ed8e02-3c2f-750c-e063-6394a90a4d33	2026-06-23	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	H E B	c68b0644-685d-4c62-bf5d-3a5bbea3b052	2026-06-22	Warnings, Adverse reactions	Exact identifier application number: M021
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	fdbadaae-eab7-4d9a-acf7-815ca93f877c	2026-06-16	Warnings	Exact identifier application number: M021
Natural Fluoride Fresh Mint cavity protection whitening fresh breath	SODIUM FLUORIDE	Tom's of Maine, Inc.	fce5e8b5-34f8-4a45-a662-82c903419809	2026-06-16	Warnings	Exact identifier application number: M021
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	ebb62015-0027-459a-a9cf-56b640f9f456	2026-06-16	Warnings	Exact identifier application number: M021
Toms Wicked Fresh Spearmint Ice fresh breath / cavity protection	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	b9962eac-186e-4da2-929d-393f18ed0234	2026-06-16	Warnings	Exact identifier application number: M021
Toms Wicked Fresh Cool Peppermint fresh breath / cavity protection	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	1c029b10-29b0-4131-9134-cebfca4328a3	2026-06-16	Warnings	Exact identifier application number: M021
Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	3e7ab39a-989c-4924-af3e-689404912bee	2026-06-16	Warnings	Exact identifier application number: M021
Crest Plus Cinnamon plus Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	53fb780d-3e8b-6747-e063-6294a90a8211	2026-06-11	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening	STANNOUS FLUORIDE	COLGATE PALMOLIVE COMPANY	7f6b6aa8-50da-151b-c448-9e427d37398f	2026-06-11	Warnings	Exact identifier application number: M021
Colgate MaxClean with Whitening Smartfoam	SODIUM FLUORIDE	Colgate-Palmolive Company	c712ae6b-eff3-4c54-b1fc-37304758d059	2026-06-11	Warnings	Exact identifier application number: M021
Colgate Total Sensitivity Mineral Shield	STANNOUS FLUORIDE	Colgate-Palmolive Company	f065318c-1e2a-c04d-f254-f8127b05a88f	2026-06-10	Warnings	Exact identifier application number: M021
Toms Whole Care Mouthwash Fresh Mint	SODIUM FLUORIDE	Tom's of Maine, Inc.	6875f5c1-853c-43da-8226-c09a5518f9bb	2026-06-10	Warnings	Exact identifier application number: M021
Colgate Total SF Fresh Mint Stripe	STANNOUS FLUORIDE	COLGATE PALMOLIVE COMPANY	657020c7-e85c-4c61-9f62-b50351e4b4e5	2026-06-10	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Bubblegum	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	1adc752b-2ba8-4d8f-b4f1-5741f864255b	2026-06-09	Warnings	Exact identifier application number: M021
Kids Crest Cavity Protection Sparkle Fun	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	df182c22-bbf1-448d-81e8-35cb431d2afc	2026-06-08	Warnings	Exact identifier application number: M021
PEROXICARE	SODIUM FLUORIDE	Church & Dwight Co., Inc.	55262538-15ce-455c-93b1-bb02b5f81d6b	2026-06-07	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