Home NDC 35000-340 COLGATE OPTIC WHITE RENEWAL REVITALIZING WHITE
Product NDC 35000-340
11-digit product format 350000340
Labeler code 35000
Product ID 35000-340_0989bf02-0835-4bee-8197-213f65740a3d
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 2026-10-13
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength 1 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 RENEWAL REVITALIZING WHITE
Brand name suffix GLISTENING MINT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM MONOFLUOROPHOSPHATE 1 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 545626 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 42 of 48 · 950 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 35000-340-63 35000034063 1 TUBE in 1 CARTON (35000-340-63) / 85 g in 1 TUBE 1 tube 2026-10-13 No No Current