Home FDA labels ceffded9-9ae7-45dc-8a60-3164c534be28 Sodium Fluoride Chewable openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
Brand name Sodium Fluoride Chewable
Generic name SODIUM FLUORIDE
Manufacturer Bryant Ranch Prepack
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 4ce32ee3-cd20-4663-a169-fa78ebd20477
SPL ID ceffded9-9ae7-45dc-8a60-3164c534be28
Version 106
Effective date 2024-08-05
Source export date 2026-09-28
Source partition 8
Source file https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:53:23 Harmonized routes table Harmonized routes ORAL
Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
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warnings WARNING Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using. This product, as all chewable tablets, is not recommended for children under age 3 due to risk of choking. Keep out of the reach of infants and children.
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adverse reactions ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.