Home NDC 63404-2210 Sensitivity and Gum with Cavity Protection
Product NDC 63404-2210
11-digit product format 634042210
Labeler code 63404
Product ID 63404-2210_8bccdcbd-ce36-40b0-a3e9-6c5d3c004242
Type HUMAN OTC DRUG
Nonproprietary name Potassium Nitrate and Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Health and Natural Beauty USA Corp
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-01-01
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 50; 7.6 mg/g; 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 Sensitivity and Gum with Cavity Protection
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 50 mg/g SODIUM FLUORIDE 7.6 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RU45X2JN0Z Internal UNII lookup 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 1426152 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 63404-2210-1 Sensitivity and Gum with Cavity Protection 142 g in 1 TUBE PASTE, DENTIFRICE 142 1 63404-2210-1 Sensitivity and Gum with Cavity Protection 1 in 1 CARTON PASTE, DENTIFRICE 1 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 32 of 40 · 786 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 63404-2210-1 63404221001 1 TUBE in 1 CARTON (63404-2210-1) / 142 g in 1 TUBE 1 tube 2020-01-01 No No Current