Home NDC 83324-291 Quality Choice
Product NDC 83324-291
11-digit product format 833240291
Labeler code 83324
Product ID 83324-291_561a75c2-a40d-ba7c-e063-6294a90aa119
Type HUMAN OTC DRUG
Nonproprietary name Fluoride
Dosage form PASTE
Route DENTAL
Labeler CHAIN DRUG MARKETING ASSOCIATION INC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-01
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 5; .15 g/100g; g/100g
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 Quality Choice
Brand name suffix Natural White
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 5 g/100g SODIUM FLUORIDE .15 g/100g
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 1038929 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 28 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 83324-291-34 83324029134 1 TUBE in 1 CARTON (83324-291-34) / 96.4 g in 1 TUBE 1 tube 2026-07-01 No No Current