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

Additional Listing Data#

Finished product
Yes
Brand name base
Cloveden 100 times higher concentrated
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE2.29 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD9OM4SK49P
Rxcui2590919

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84516-040-01Cloveden 100 times higher concentrated50 mL in 1 BOTTLEMOUTHWASH501
84516-040-02Cloveden 100 times higher concentrated1 in 1 CARTONMOUTHWASH11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2590919cetylpyridinium chloride 2.3 % Concentrated MouthwashPSN3c0e1862-293f-4d23-e063-6294a90a33e11
2590919cetylpyridinium chloride 23 MG/ML MouthwashSCD3c0e1862-293f-4d23-e063-6294a90a33e11
2590919cetylpyridinium chloride 2.296 % MouthwashSY3c0e1862-293f-4d23-e063-6294a90a33e11
2590919cetylpyridinium chloride 2.3 % MouthwashSY3c0e1862-293f-4d23-e063-6294a90a33e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84516-040-018451600400150 mL in 1 BOTTLE50 mlHistorical
84516-040-02845160040021 BOTTLE in 1 CARTON (84516-040-02) / 50 mL in 1 BOTTLE (84516-040-01) 1 bottle2025-08-01NoNoHistorical