FDA.reportPublic FDA data

Colgate Total Active Prevention Spearmint

Product NDC
35000-280
11-digit product format
350000280
Labeler code
35000
Product ID
35000-280_dd421c43-2948-47c1-af6b-a32b68212635
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE15 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD9OM4SK49P
Rxcui1599135, 1599137

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-280-16Colgate Total Active Prevention Spearmint500 mL in 1 BOTTLERINSE5001
35000-280-31Colgate Total Active Prevention Spearmint1000 mL in 1 BOTTLERINSE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-280COLGATE TOTAL ACTIVE PREVENTION SPEARMINT (CETYLPYRIDINIUM CHLORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1Current NDC, 2 package rows20241101_5e562145-6fb2-4797-b111-5808afec7046.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599135cetylpyridinium chloride 0.075 % MouthwashPSN5e562145-6fb2-4797-b111-5808afec70461
1599137Colgate Total Advanced Pro-Shield 0.075 % MouthwashPSN5e562145-6fb2-4797-b111-5808afec70461
1599137cetylpyridinium chloride 0.75 MG/ML Mouthwash [Colgate Total Mouthwash]SBD5e562145-6fb2-4797-b111-5808afec70461
1599135cetylpyridinium chloride 0.75 MG/ML MouthwashSCD5e562145-6fb2-4797-b111-5808afec70461
1599135cetylpyridinium chloride 0.075 % MouthwashSY5e562145-6fb2-4797-b111-5808afec70461
1599137Colgate Total 0.75 MG/ML MouthwashSY5e562145-6fb2-4797-b111-5808afec70461
1599137Colgate Total Advanced Pro-Shield 0.075 % MouthwashSY5e562145-6fb2-4797-b111-5808afec70461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-280-1635000028016500 mL in 1 BOTTLE (35000-280-16) 500 ml2024-10-31NoNoCurrent
35000-280-31350000280311000 mL in 1 BOTTLE (35000-280-31) 1000 ml2024-10-31NoNoCurrent