Antigingivitis/Antiplaque

Product NDC
76162-090
11-digit product format
761620090
Labeler code
76162
Product ID
76162-090_4aba08c6-5e07-e60a-e063-6394a90abde8
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
2024-04-05
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.7 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.7 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD9OM4SK49P
Rxcui1100924

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
76162-090-86Antigingivitis/Antiplaque1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-090ANTIGINGIVITIS/ANTIPLAQUE (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]2Current NDC, 1 package rows20250425_c20cbcca-1509-491b-9ec4-3d9611b31159.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSNc20cbcca-1509-491b-9ec4-3d9611b311593
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCDc20cbcca-1509-491b-9ec4-3d9611b311593
1100924cetylpyridinium chloride 0.07 % Oral RinseSYc20cbcca-1509-491b-9ec4-3d9611b311593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-090-86761620090861000 mL in 1 BOTTLE, PLASTIC (76162-090-86) 1000 ml2024-04-05NoNoHistorical