Home NDC 35000-280 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 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.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Additional Listing Data#
Finished product Yes
Brand name base Colgate Total Active Prevention Spearmint
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETYLPYRIDINIUM CHLORIDE 15 mg/20mL
Harmonized Identifiers# Field, Values table Field Values Unii D9OM4SK49P Rxcui 1599135, 1599137
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 35000-280-16 Colgate Total Active Prevention Spearmint 500 mL in 1 BOTTLE RINSE 500 1 35000-280-31 Colgate Total Active Prevention Spearmint 1000 mL in 1 BOTTLE RINSE 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35000-280 COLGATE TOTAL ACTIVE PREVENTION SPEARMINT (CETYLPYRIDINIUM CHLORIDE) RINSE [COLGATE-PALMOLIVE COMPANY] 1 Current NDC, 2 package rows 20241101_5e562145-6fb2-4797-b111-5808afec7046.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 35000-280-16 35000028016 500 mL in 1 BOTTLE (35000-280-16) 500 ml 2024-10-31 No No Current 35000-280-31 35000028031 1000 mL in 1 BOTTLE (35000-280-31) 1000 ml 2024-10-31 No No Current