Antigingivitis/Antiplaque

Product NDC
59450-997
11-digit product format
594500997
Labeler code
59450
Product ID
59450-997_4bd21344-e34f-9f71-e063-6294a90aec5b
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium Chloride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
The Kroger Co.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-22
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
59450-997-86Antigingivitis/Antiplaque1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59450-997ANTIGINGIVITIS/ANTIPLAQUE (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [THE KROGER CO]3Current NDC, Legacy NDC, 1 package rows20240913_922bff32-7536-4a6d-b04b-0b02f14fbecc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN922bff32-7536-4a6d-b04b-0b02f14fbecc5
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD922bff32-7536-4a6d-b04b-0b02f14fbecc5
1100924cetylpyridinium chloride 0.07 % Oral RinseSY922bff32-7536-4a6d-b04b-0b02f14fbecc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59450-997-86594500997861000 mL in 1 BOTTLE, PLASTIC (59450-997-86) 1000 ml2022-09-220000-00-00NoNoCurrent