Home NDC 35573-434-51 Sodium Fluoride 5000 ppm
Product NDC 35573-434
Requested package NDC 35573-434-51
11-digit product format 355730434
Labeler code 35573
Product ID 35573-434_70124866-ecd6-494c-90da-d1e2ad0c8100
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Burel Pharmaceuticals LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2020-02-28
Marketing end 0000-00-00
Substance SODIUM FLUORIDE
Active strength 5 mg/g
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 35573-434 35573-434-51 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35573-434 SODIUM FLUORIDE 5000 PPM (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUREL PHARMACEUTICALS LLC] 3 Legacy NDC 20221217_a7c63ceb-cd8a-4056-ae69-eb6b59248334.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 35573-434-51 35573043451 1 TUBE in 1 CARTON (35573-434-51) > 51 g in 1 TUBE 1 tube 2020-02-28 0000-00-00 No No Current