Home NDC 35000-899 Colgate Max Fresh
Product NDC 35000-899
11-digit product format 350000899
Labeler code 35000
Product ID 35000-899_61aad525-7efb-4404-bc6c-ab625e045332
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 2021-10-16
Substance SODIUM FLUORIDE
Active strength 2.4 mg/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 19 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Max Fresh
Brand name suffix Advanced Whitening
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 2.4 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 35000-899-34 Colgate Max FreshAdvanced Whitening 2 in 1 CARTON GEL, DENTIFRICE 2 7 35000-899-34 Colgate Max FreshAdvanced Whitening 170 g in 1 TUBE GEL, DENTIFRICE 170 7 35000-899-58 Colgate Max FreshAdvanced Whitening 70.87 g in 1 TUBE GEL, DENTIFRICE 70.87 7 35000-899-58 Colgate Max FreshAdvanced Whitening 1 in 1 CARTON GEL, DENTIFRICE 1 7 35000-899-60 Colgate Max FreshAdvanced Whitening 1 in 1 CARTON GEL, DENTIFRICE 1 7 35000-899-60 Colgate Max FreshAdvanced Whitening 170 g in 1 TUBE GEL, DENTIFRICE 170 7 35000-899-78 Colgate Max FreshAdvanced Whitening 1 in 1 CARTON GEL, DENTIFRICE 1 7 35000-899-78 Colgate Max FreshAdvanced Whitening 70.8 g in 1 TUBE GEL, DENTIFRICE 70.8 7 35000-899-95 Colgate Max FreshAdvanced Whitening 1 in 1 CARTON GEL, DENTIFRICE 1 7 35000-899-95 Colgate Max FreshAdvanced Whitening 178 g in 1 TUBE GEL, DENTIFRICE 178 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35000-899 COLGATE MAX FRESH ADVANCED WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY] 6 Current NDC, Legacy NDC, 10 package rows 20250110_01c07c25-2748-4d90-9505-094e2c977c9c.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 4 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 Marketing end Sample Exclude flag Status 35000-899-34 35000089934 2 TUBE in 1 CARTON (35000-899-34) > 170 g in 1 TUBE 2 tube 2021-10-16 0000-00-00 No No Current 35000-899-58 35000089958 70.87 g in 1 TUBE 70.87 g Historical 35000-899-60 35000089960 1 TUBE in 1 CARTON (35000-899-60) > 170 g in 1 TUBE 1 tube 2021-10-16 0000-00-00 No No Current 35000-899-78 35000089978 1 TUBE in 1 CARTON (35000-899-78) / 70.8 g in 1 TUBE 1 tube 2024-01-01 No No Current 35000-899-95 35000089995 1 TUBE in 1 CARTON (35000-899-95) / 178 g in 1 TUBE 1 tube 2021-10-16 2027-09-01 No No Current