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: Fluoride
Generic name: SODIUM FLUORIDE
Manufacturer: WINDER LABORATORIES, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 0df8f1aa-f3ef-9f59-e063-6294a90a0666
SPL ID: 47a68277-53e0-538f-e063-6394a90aa82c
Version: 2
Effective date: 2026-01-05
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:17:14

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 · 18 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Fluoride	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		WINDER LABORATORIES, LLC	openfda.manufacturer_name
ndc	package	75826-164-20	openfda.package_ndc
ndc	package	75826-163-20	openfda.package_ndc
ndc	package	75826-165-20	openfda.package_ndc
ndc	product	75826-164	openfda.product_ndc
ndc	product	75826-165	openfda.product_ndc
ndc	product	75826-163	openfda.product_ndc
ndc11	package	75826016320	derived:openfda.package_ndc
ndc11	package	75826016420	derived:openfda.package_ndc
ndc11	package	75826016520	derived:openfda.package_ndc
rxcui		198215	openfda.rxcui
rxcui		313036	openfda.rxcui
rxcui		315213	openfda.rxcui
spl id		47a68277-53e0-538f-e063-6394a90aa82c	id
spl set id		0df8f1aa-f3ef-9f59-e063-6294a90a0666	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#

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

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

adverse reactions

ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1(800) FDA-1088.

Reported adverse events (FAERS/openFDA)#

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