Antiseptic

Product NDC
11344-299
11-digit product format
113440299
Labeler code
11344
Product ID
11344-299_4cea05a3-8aea-57c5-e063-6394a90a7235
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium Chloride
Dosage form
RINSE
Route
ORAL
Labeler
Nice-Pak Products, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-29
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
Antiseptic
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
11344-299-77Antiseptic500 mL in 1 BOTTLE, PLASTICRINSE5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-299ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [CONSUMER PRODUCT PARTNERS, LLC]3Current NDC, 1 package rows20250515_98c0dadd-c8f9-4955-bd0d-70b14dcf00c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN98c0dadd-c8f9-4955-bd0d-70b14dcf00c24
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD98c0dadd-c8f9-4955-bd0d-70b14dcf00c24
1100924cetylpyridinium chloride 0.07 % Oral RinseSY98c0dadd-c8f9-4955-bd0d-70b14dcf00c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-299-7711344029977500 mL in 1 BOTTLE, PLASTIC (11344-299-77) 500 ml2024-04-29NoNoCurrent