Home NDC 35000-903-01 Colgate
Product NDC 35000-903
Requested package NDC 35000-903-01
11-digit product format 350000903
Labeler code 35000
Product ID 35000-903_14f9feea-6d53-476e-84c5-4a6cabd5c0ac
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Colgate-Palmolive Company
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-08-01
Substance SODIUM FLUORIDE
Active strength 1.1 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
Brand name suffix Max Fresh Cool Mint
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416783 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 35000-903-01 ColgateMax Fresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 6 35000-903-01 ColgateMax Fresh Cool Mint 28.3 g in 1 TUBE GEL, DENTIFRICE 28.3 6 35000-903-58 ColgateMax Fresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 6 35000-903-58 ColgateMax Fresh Cool Mint 70 g in 1 TUBE GEL, DENTIFRICE 70 6 35000-903-60 ColgateMax Fresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 6 35000-903-60 ColgateMax Fresh Cool Mint 170 g in 1 TUBE GEL, DENTIFRICE 170 6 35000-903-75 ColgateMax Fresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 6 35000-903-75 ColgateMax Fresh Cool Mint 79 g in 1 TUBE GEL, DENTIFRICE 79 6 35000-903-78 ColgateMax Fresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 6 35000-903-78 ColgateMax Fresh Cool Mint 221 g in 1 TUBE GEL, DENTIFRICE 221 6 35000-903-95 ColgateMax Fresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 6 35000-903-95 ColgateMax Fresh Cool Mint 178 g in 1 TUBE GEL, DENTIFRICE 178 6 35000-903-99 ColgateMax Fresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 6 35000-903-99 ColgateMax Fresh Cool Mint 53 g in 1 TUBE GEL, DENTIFRICE 53 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35000-903 COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY] 4 Current NDC, Legacy NDC, 14 package rows 20241127_00652bb2-090c-4eaa-8fc2-e0be6913a724.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 33 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 Marketing end Sample Exclude flag Status 35000-903-01 35000090301 1 TUBE in 1 CARTON (35000-903-01) / 28.3 g in 1 TUBE 1 tube 2020-05-18 0000-00-00 No No Current