Home NDC 63404-2105 Sensitivity Relief Fluoride Free
Product NDC 63404-2105
11-digit product format 634042105
Labeler code 63404
Product ID 63404-2105_8b7a44b8-4906-41dd-a8ec-a56eb779c899
Type HUMAN OTC DRUG
Nonproprietary name Potassium Nitrate
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Health and Natural Beauty USA Corp
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-01-01
Substance POTASSIUM NITRATE
Active strength 50 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 Relief Fluoride Free
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RU45X2JN0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312544 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 27 of 40 · 786 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 63404-2105-1 63404210501 1 TUBE in 1 CARTON (63404-2105-1) / 100 g in 1 TUBE 1 tube 2018-01-01 No No Current