Home NDC 35000-731 Colgate Total 12 Hr Pro-Shield Spearmint Surge
Product NDC 35000-731
11-digit product format 350000731
Labeler code 35000
Product ID 35000-731_50ba6069-a202-47de-8fd0-cf7605b30451
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 2015-09-01
Marketing end 2026-12-31
Substance CETYLPYRIDINIUM CHLORIDE
Active strength 15 mg/20mL
NDC exclude flag No
Current FDA listing Yes NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded package package 35000-731 35000-731-50 D Discontinued by firm 2026-07-31
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 12 Hr Pro-Shield Spearmint Surge 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 35000-731-02 Colgate Total 12 Hr Pro-Shield Spearmint Surge 60 mL in 1 BOTTLE RINSE 60 15 35000-731-16 Colgate Total 12 Hr Pro-Shield Spearmint Surge 500 mL in 1 BOTTLE RINSE 500 15 35000-731-33 Colgate Total 12 Hr Pro-Shield Spearmint Surge 1000 mL in 1 BOTTLE RINSE 1000 15 35000-731-50 Colgate Total 12 Hr Pro-Shield Spearmint Surge 1500 mL in 1 BOTTLE RINSE 1500 15 35000-731-84 Colgate Total 12 Hr Pro-Shield Spearmint Surge 250 mL in 1 BOTTLE RINSE 250 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35000-731 COLGATE TOTAL 12 HR PRO-SHIELD SPEARMINT SURGE (CETYLPYRIDINIUM CHLORIDE) RINSE [COLGATE-PALMOLIVE COMPANY] 11 Current NDC, Legacy NDC, 5 package rows 20250221_91fcccfe-aaef-45ee-a5d2-70a3939439ee.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 35000-731-02 35000073102 60 mL in 1 BOTTLE (35000-731-02) 60 ml 2015-09-01 2026-12-31 No No Current 35000-731-16 35000073116 500 mL in 1 BOTTLE (35000-731-16) 500 ml 2015-09-01 2026-12-31 No No Current 35000-731-33 35000073133 1000 mL in 1 BOTTLE (35000-731-33) 1000 ml 2015-09-01 2026-12-31 No No Current 35000-731-50 35000073150 1500 mL in 1 BOTTLE (35000-731-50) 1500 ml 2015-09-01 0000-00-00 No No Current 35000-731-84 35000073184 250 mL in 1 BOTTLE (35000-731-84) 250 ml 2015-09-01 2026-12-31 No No Current