Sodium Fluoride

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
Generic name: SODIUM FLUORIDE
Manufacturer: Method Pharmaceuticals, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 35dcc144-130d-4ec7-a266-c084008ac70c
SPL ID: 41b6cf2b-2810-7774-e063-6394a90ac1fb
Version: 6
Effective date: 2025-10-21
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 05:54:38

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	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		Method Pharmaceuticals, LLC	openfda.manufacturer_name
ndc	package	58657-322-50	openfda.package_ndc
ndc	product	58657-322	openfda.product_ndc
ndc11	package	58657032250	derived:openfda.package_ndc
rxcui		315102	openfda.rxcui
spl id		41b6cf2b-2810-7774-e063-6394a90ac1fb	id
spl set id		35dcc144-130d-4ec7-a266-c084008ac70c	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

Warnings 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. 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. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or Method Pharmaceuticals, LLC at 877-250-3427. Store at controlled room temperature 15° to 30°C (59° to 86°F).

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.