Antigingivitis/Antiplaque

Product NDC
76162-953
11-digit product format
761620953
Labeler code
76162
Product ID
76162-953_4aba1791-ba47-f1f3-e063-6394a90a55f2
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium Chloride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Topco Associates LLC
Application
M505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-18
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.5 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Antigingivitis/Antiplaque
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD9OM4SK49P
Rxcui1251617

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-953-86Antigingivitis/Antiplaque1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-953ANTIGINGIVITIS/ANTIPLAQUE (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]2Current NDC, 1 package rows20250425_3fefe9b3-d61d-494d-bd85-5d2cf8321398.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN3fefe9b3-d61d-494d-bd85-5d2cf83213983
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD3fefe9b3-d61d-494d-bd85-5d2cf83213983
1251617cetylpyridinium chloride 0.05 % MouthwashSY3fefe9b3-d61d-494d-bd85-5d2cf83213983

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-953-86761620953861000 mL in 1 BOTTLE, PLASTIC (76162-953-86) 1000 ml2024-04-18NoNoHistorical