Home NDC 35000-281 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 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 Ingredient Strength CETYLPYRIDINIUM CHLORIDE 15 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D9OM4SK49P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1599135 Internal RxNorm lookup 1599137 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 35000-281-16 Colgate Total Active Prevention Gum Health 500 mL in 1 BOTTLE RINSE 500 1 35000-281-31 Colgate Total Active Prevention Gum Health 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 35000-281 COLGATE TOTAL ACTIVE PREVENTION GUM HEALTH (CETYLPYRIDINIUM CHLORIDE) RINSE [COLGATE-PALMOLIVE COMPANY] 1 Current NDC, 2 package rows 20241101_fb63b8bb-826a-42e6-a429-b8d86c5c9223.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 35000-281-16 35000028116 500 mL in 1 BOTTLE (35000-281-16) 500 ml 2024-10-31 No No Current 35000-281-31 35000028131 1000 mL in 1 BOTTLE (35000-281-31) 1000 ml 2024-10-31 No No Current