Home NDC 35000-792 COLGATE OPTIC WHITE PRO SERIES HIGH IMPACT WHITE
Product NDC 35000-792
11-digit product format 350000792
Labeler code 35000
Product ID 35000-792_a68e4876-1443-41b5-9b5c-a84c21579233
Type HUMAN OTC DRUG
Nonproprietary name SODIUM MONOFLUOROPHOSPHATE
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Colgate-Palmolive Company
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-21
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength 1.5 mg/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base COLGATE OPTIC WHITE PRO SERIES HIGH IMPACT WHITE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C810JCZ56Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1038995 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 35000-792-63 COLGATE OPTIC WHITE PRO SERIES HI WHITE 85 g in 1 TUBE PASTE, DENTIFRICE 85 1 35000-792-63 COLGATE OPTIC WHITE PRO SERIES HI WHITE 1 in 1 CARTON PASTE, DENTIFRICE 1 1
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 22 of 50 · 995 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 35000-792-63 35000079263 1 TUBE in 1 CARTON (35000-792-63) / 85 g in 1 TUBE 1 tube 2025-10-21 No No Current