Cepacol

Product NDC
63824-790
11-digit product format
638240790
Labeler code
63824
Product ID
63824-790_51b5db79-cd73-82f1-e063-6294a90ad768
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium chloride
Dosage form
LIQUID
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-06-22
Marketing end
2027-09-03
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.05 g/100mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cepacol
Brand name suffix
Antibacterial

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.05 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD9OM4SK49P
Rxcui1251617, 1251619

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-790-80CepacolAntibacterial710 mL in 1 BOTTLELIQUID7109
63824-790-80CepacolAntibacterial1 in 1 CARTONLIQUID19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-790-80ML - Milliliter63824-7900e050fc7-6f10-44dc-8ff9-076da5954e9c12013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetylpyridinium chlorideACTIVE INGREDIENTD9OM4SK49PCEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RECKITT BENCKISER LLC]3
CetylpyridiniumACTIVE MOIETYCUB7JI0JV3CEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RECKITT BENCKISER LLC]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MCEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RECKITT BENCKISER LLC]3
CINNAMON OILINACTIVE INGREDIENTE5GY4I6YCZCEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RECKITT BENCKISER LLC]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RECKITT BENCKISER LLC]3
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662CEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RECKITT BENCKISER LLC]3
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MCEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RECKITT BENCKISER LLC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RECKITT BENCKISER LLC]3
MENTHOLINACTIVE INGREDIENTL7T10EIP3ACEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RECKITT BENCKISER LLC]3
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YCEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RECKITT BENCKISER LLC]3
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHCEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RECKITT BENCKISER LLC]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RECKITT BENCKISER LLC]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RECKITT BENCKISER LLC]3
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74CEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RECKITT BENCKISER LLC]3
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSINACTIVE INGREDIENTKH7I04HPUUCEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RECKITT BENCKISER LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RCEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RECKITT BENCKISER LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-790CEPACOL ANTIBACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [RB HEALTH (US) LLC]7Current NDC, Legacy NDC, 2 package rows20241220_7c19eba6-3ebd-497f-9066-6152b72eafdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251619Cepacol Antibacterial 0.05 % MouthwashPSN7c19eba6-3ebd-497f-9066-6152b72eafdd9
1251617cetylpyridinium chloride 0.05 % MouthwashPSN7c19eba6-3ebd-497f-9066-6152b72eafdd9
1251619cetylpyridinium chloride 0.5 MG/ML Mouthwash [Cepacol Antibacterial Mouthwash]SBD7c19eba6-3ebd-497f-9066-6152b72eafdd9
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD7c19eba6-3ebd-497f-9066-6152b72eafdd9
1251619Cepacol Antibacterial Mouthwash 0.5 MG/ML MouthwashSY7c19eba6-3ebd-497f-9066-6152b72eafdd9
1251619Cepacol Antibacterial Multi-Protection Mouthwash 0.5 MG/ML MouthwashSY7c19eba6-3ebd-497f-9066-6152b72eafdd9
1251617cetylpyridinium chloride 0.05 % MouthwashSY7c19eba6-3ebd-497f-9066-6152b72eafdd9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-790-80638240790801 BOTTLE in 1 CARTON (63824-790-80) / 710 mL in 1 BOTTLE1 bottle2011-06-222027-09-03NoNoCurrent