Home NDC 35000-998 Colgate Optic White Stain Fighter Sens Relief
Product NDC 35000-998
11-digit product format 350000998
Labeler code 35000
Product ID 35000-998_53744624-454a-4b7a-b87b-08ea33e238aa
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Colgate-Palmolive Company
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-11-01
Marketing end 2027-11-01
Substance SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength 1.5; 50 mg/g; mg/g
NDC exclude flag No
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 Stain Fighter Sens Relief Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.5 mg/g POTASSIUM NITRATE 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1038929 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 35000-998-60 Colgate Optic White Stain Fighter Sens Relief 1 in 1 CARTON PASTE, DENTIFRICE 1 8 35000-998-60 Colgate Optic White Stain Fighter Sens Relief 85 g in 1 TUBE PASTE, DENTIFRICE 85 8 35000-998-71 Colgate Optic White Stain Fighter Sens Relief 1 in 1 CARTON PASTE, DENTIFRICE 1 8 35000-998-71 Colgate Optic White Stain Fighter Sens Relief 119 g in 1 TUBE PASTE, DENTIFRICE 119 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35000-998 COLGATE OPTIC WHITE STAIN FIGHTER SENS RELIEF (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY] 8 Current NDC, 4 package rows 20240608_6ec2fff7-df44-4302-be2d-97946c6cd66a.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 28 of 40 · 786 matching rows.
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 35000-998-60 35000099860 1 TUBE in 1 CARTON (35000-998-60) / 85 g in 1 TUBE 1 tube 2022-11-01 2027-10-01 No No Historical 35000-998-71 35000099871 1 TUBE in 1 CARTON (35000-998-71) / 119 g in 1 TUBE 1 tube 2022-11-01 2027-11-01 No No Historical