Home NDC 35000-015 Colgate Kids Cavity Protection
Product NDC 35000-015
11-digit product format 350000015
Labeler code 35000
Product ID 35000-015_797bdeba-41cd-4158-ab93-5e6470e1f85b
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 2016-11-11
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 Kids Cavity Protection
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 35000-015-32 Colgate Kids Cavity Protection 90 g in 1 TUBE GEL, DENTIFRICE 90 1 35000-015-46 Colgate Kids Cavity Protection 130 g in 1 TUBE GEL, DENTIFRICE 130 1
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 5 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 Sample Exclude flag Status 35000-015-20 35000001520 1 TUBE in 1 CARTON (35000-015-20) / 24 g in 1 TUBE 1 tube 2016-11-11 No No Current 35000-015-32 35000001532 90 g in 1 TUBE (35000-015-32) 90 g 2025-01-01 No No Current 35000-015-45 35000001545 2 TUBE in 1 CARTON (35000-015-45) / 130 g in 1 TUBE 2 tube 2024-01-01 No No Current 35000-015-46 35000001546 130 g in 1 TUBE (35000-015-46) 130 g 2020-05-05 No No Current 35000-015-47 35000001547 1 TUBE in 1 CARTON (35000-015-47) / 130 g in 1 TUBE 1 tube 2017-12-07 No No Current 35000-015-59 35000001559 1 TUBE in 1 CARTON (35000-015-59) / 76 g in 1 TUBE 1 tube 2016-11-11 No No Current