Home NDC 35000-214 Colgate MaxFresh Knockout
Product NDC 35000-214
11-digit product format 350000214
Labeler code 35000
Product ID 35000-214_74d13300-bf75-4f8a-a1fa-a63c044a007c
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 2025-02-03
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 MaxFresh Knockout
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 35000-214-30 Colgate MaxFresh Knockout 3 in 1 CELLO PACK GEL, DENTIFRICE 3 1 35000-214-30 Colgate MaxFresh Knockout 1 in 1 CARTON GEL, DENTIFRICE 1 1 35000-214-95 Colgate MaxFresh Knockout 178 g in 1 TUBE GEL, DENTIFRICE 178 1 35000-214-95 Colgate MaxFresh Knockout 1 in 1 CARTON GEL, DENTIFRICE 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35000-214 COLGATE MAXFRESH KNOCKOUT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY] 1 Current NDC, 4 package rows 20250204_0ffbb3a9-7bfa-4f6a-aef3-fde327a410c9.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 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 35000-214-30 35000021430 3 CARTON in 1 CELLO PACK (35000-214-30) / 1 TUBE in 1 CARTON / 178 g in 1 TUBE 3 carton 2025-02-03 No No Current 35000-214-95 35000021495 1 TUBE in 1 CARTON (35000-214-95) / 178 g in 1 TUBE 1 tube 2025-02-03 No No Current