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 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
1100924Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c20cbcca-1509-491b-9ec4-3d9611b31159Available on FDA.report

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

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 CHLORIDETopco Associates LLCc20cbcca-1509-491b-9ec4-3d9611b311592026-02-13Warnings, Adverse reactionsExact identifier
ndc (product): 76162-090

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 ml2024-04-05NoNoCurrent