Home NDC 35573-435 Sodium Fluoride 1.1%
Product NDC 35573-435
11-digit product format 355730435
Labeler code 35573
Product ID 35573-435_43929099-b98f-86b0-e063-6394a90a83e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Fluoride
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Burel Pharmaceuticals LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2020-02-28
Substance SODIUM FLUORIDE
Active strength 5 mg/g
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 Sodium Fluoride 1.1%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 5 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 1486566 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 35573-435-56 Sodium Fluoride 1.1% 56 g in 1 TUBE GEL, DENTIFRICE 56 5 35573-435-56 Sodium Fluoride 1.1% 1 in 1 CARTON GEL, DENTIFRICE 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35573-435 SODIUM FLUORIDE 1.1% (SODIUM FLUORIDE) GEL, DENTIFRICE [BUREL PHARMACEUTICALS LLC] 3 Current NDC, Legacy NDC, 2 package rows 20221217_6e021467-08b3-40b3-9a39-2e9d9830085d.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 1 of 1 · 1 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 35573-435-56 35573043556 1 TUBE in 1 CARTON (35573-435-56) / 56 g in 1 TUBE 1 tube 2020-02-28 0000-00-00 No No Current