Home NDC 52000-109 UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE
Product NDC 52000-109
11-digit product format 520000109
Labeler code 52000
Product ID 52000-109_1199f2f8-98e4-4b76-9be9-3b921495a3c3
Type HUMAN OTC DRUG
Nonproprietary name potassium nitrate and sodium fluoride
Dosage form PASTE
Route DENTAL
Labeler Universal Distribution Center LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-05-20
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 5; .15 g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
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 UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE
Listing expiration 2026-12-31 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 1038841 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 52000-109-01 UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE 122 g in 1 TUBE PASTE 122 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52000-109 UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [UNIVERSAL DISTRIBUTION CENTER LLC] 2 Current NDC, Legacy NDC, 1 package rows 20231121_fcf59439-7e06-4129-a89f-cdeecdf8d488.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 27 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 Marketing end Sample Exclude flag Status 52000-109-01 52000010901 122 g in 1 TUBE (52000-109-01) 122 g 2020-05-20 0000-00-00 No No Current