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: Method Pharmaceuticals, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: e2061541-bf1c-4ee3-afde-36894394dbea
SPL ID: 41b579ba-642e-b6d6-e063-6394a90a8e24
Version: 7
Effective date: 2025-10-21
Source export date: 2026-11-06
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/824fe785252d7061429a95ddb6de517ee399ef628d34e8fdcc3591ded286ae33/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:25:47

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 · 20 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		Method Pharmaceuticals, LLC	openfda.manufacturer_name
ndc	package	58657-162-12	openfda.package_ndc
ndc	package	58657-161-12	openfda.package_ndc
ndc	package	58657-161-10	openfda.package_ndc
ndc	package	58657-160-12	openfda.package_ndc
ndc	product	58657-161	openfda.product_ndc
ndc	product	58657-162	openfda.product_ndc
ndc	product	58657-160	openfda.product_ndc
ndc11	package	58657016012	derived:openfda.package_ndc
ndc11	package	58657016212	derived:openfda.package_ndc
ndc11	package	58657016112	derived:openfda.package_ndc
ndc11	package	58657016110	derived:openfda.package_ndc
rxcui		198215	openfda.rxcui
rxcui		313036	openfda.rxcui
rxcui		315213	openfda.rxcui
spl id		41b579ba-642e-b6d6-e063-6394a90a8e24	id
spl set id		e2061541-bf1c-4ee3-afde-36894394dbea	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.

Reported adverse events (FAERS/openFDA)#

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