Home NDC 35000-060 Colgate Cavity Protection Great Regular Flavor
Product NDC 35000-060
11-digit product format 350000060
Labeler code 35000
Product ID 35000-060_426e2d65-a591-476a-b6a4-83375d7a0307
Type HUMAN OTC DRUG
Nonproprietary name Anticavity Fluoride toothpaste
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Colgate-Palmolive Company
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-22
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 Cavity Protection Great Regular Flavor
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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 35000-060-48 Colgate Cavity Protection Great Regular Flavor 226 g in 1 TUBE PASTE, DENTIFRICE 226 5 35000-060-48 Colgate Cavity Protection Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 5
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 45 of 49 · 974 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 35000-060-48 35000006048 1 TUBE in 1 CARTON (35000-060-48) / 226 g in 1 TUBE 1 tube 2026-01-22 No No Current 35000-060-60 35000006060 1 TUBE in 1 CARTON (35000-060-60) / 170 g in 1 TUBE 1 tube 2026-06-22 No No Current