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: 2026-08-01
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/2026-08-01/206e0852f7011b53c21719ec5c68ac6752381d0fcd1d348f7428adad64429e89/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run: 20260801T225920Z
Imported at: 2026-08-01 23:18:01

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.

Harmonized identifiers page 1 of 1 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Sodium Fluoride Chewable	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		Bryant Ranch Prepack	openfda.manufacturer_name
ndc	package	63629-1133-1	openfda.package_ndc
ndc	product	63629-1133	openfda.product_ndc
ndc11	package	63629113301	derived:openfda.package_ndc
rxcui		315213	openfda.rxcui
spl id		ceffded9-9ae7-45dc-8a60-3164c534be28	id
spl set id		4ce32ee3-cd20-4663-a169-fa78ebd20477	set_id
unii		8ZYQ1474W7	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

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.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported.