Antigingivitis/Antiplaque

Product NDC
59450-953
11-digit product format
594500953
Labeler code
59450
Product ID
59450-953_4bd25cd6-b966-f67a-e063-6394a90addfc
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
2023-11-13
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D9OM4SK49PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1251617Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0e61d4a1-0b81-4bca-bdb3-b9927278b769Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59450-953-86Antigingivitis/Antiplaque1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59450-953ANTIGINGIVITIS/ANTIPLAQUE (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [KROGER]2Current NDC, 1 package rows20240913_0e61d4a1-0b81-4bca-bdb3-b9927278b769.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antigingivitis/AntiplaqueCETYLPYRIDINIUM CHLORIDEThe Kroger Co.0e61d4a1-0b81-4bca-bdb3-b9927278b7692026-02-27Warnings, Adverse reactionsExact identifier
ndc (product): 59450-953

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN0e61d4a1-0b81-4bca-bdb3-b9927278b7694
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD0e61d4a1-0b81-4bca-bdb3-b9927278b7694
1251617cetylpyridinium chloride 0.05 % MouthwashSY0e61d4a1-0b81-4bca-bdb3-b9927278b7694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59450-953-86594500953861000 mL in 1 BOTTLE, PLASTIC (59450-953-86) 1000 ml2023-11-13NoNoCurrent