FDA.reportPublic FDA data

Colgate Total Active Prevention Gum Health

Product NDC
35000-281
11-digit product format
350000281
Labeler code
35000
Product ID
35000-281_1fd3db84-50ed-40bd-b913-8dea8203c96e
Type
HUMAN OTC DRUG
Nonproprietary name
CETYLPYRIDINIUM CHLORIDE
Dosage form
RINSE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-31
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
15 mg/20mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total Active Prevention Gum HealthCETYLPYRIDINIUM CHLORIDEColgate-Palmolive Companyfb63b8bb-826a-42e6-a429-b8d86c5c92232024-10-04WarningsExact identifier
ndc (product): 35000-281

Additional Listing Data#

Finished product
Yes
Brand name base
Colgate Total Active Prevention Gum Health
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE15 mg/20mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1599135Internal RxNorm lookup
1599137Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb63b8bb-826a-42e6-a429-b8d86c5c9223Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-281-16Colgate Total Active Prevention Gum Health500 mL in 1 BOTTLERINSE5001
35000-281-31Colgate Total Active Prevention Gum Health1000 mL in 1 BOTTLERINSE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-281COLGATE TOTAL ACTIVE PREVENTION GUM HEALTH (CETYLPYRIDINIUM CHLORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1Current NDC, 2 package rows20241101_fb63b8bb-826a-42e6-a429-b8d86c5c9223.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599135cetylpyridinium chloride 0.075 % MouthwashPSNfb63b8bb-826a-42e6-a429-b8d86c5c92231
1599137Colgate Total Advanced Pro-Shield 0.075 % MouthwashPSNfb63b8bb-826a-42e6-a429-b8d86c5c92231
1599137cetylpyridinium chloride 0.75 MG/ML Mouthwash [Colgate Total Mouthwash]SBDfb63b8bb-826a-42e6-a429-b8d86c5c92231
1599135cetylpyridinium chloride 0.75 MG/ML MouthwashSCDfb63b8bb-826a-42e6-a429-b8d86c5c92231
1599135cetylpyridinium chloride 0.075 % MouthwashSYfb63b8bb-826a-42e6-a429-b8d86c5c92231
1599137Colgate Total 0.75 MG/ML MouthwashSYfb63b8bb-826a-42e6-a429-b8d86c5c92231
1599137Colgate Total Advanced Pro-Shield 0.075 % MouthwashSYfb63b8bb-826a-42e6-a429-b8d86c5c92231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-281-1635000028116500 mL in 1 BOTTLE (35000-281-16) 500 ml2024-10-31NoNoCurrent
35000-281-31350000281311000 mL in 1 BOTTLE (35000-281-31) 1000 ml2024-10-31NoNoCurrent