Sodium Fluoride 5000 ppm Dry Mouth

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 5000 ppm Dry Mouth
Generic name: SODIUM FLUORIDE
Manufacturer: Sheffield Pharmaceuticals LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: cbc67f03-55c4-4781-ba37-87c737b60282
SPL ID: 6bf92fe3-34f9-4d29-8312-3f65639c05ae
Version: 2
Effective date: 2021-03-02
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:03:32

Harmonized routes table
Harmonized routes
DENTAL

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 5000 ppm Dry Mouth	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		Sheffield Pharmaceuticals LLC	openfda.manufacturer_name
ndc	package	11527-755-34	openfda.package_ndc
ndc	product	11527-755	openfda.product_ndc
ndc11	package	11527075534	derived:openfda.package_ndc
rxcui		392038	openfda.rxcui
spl id		6bf92fe3-34f9-4d29-8312-3f65639c05ae	id
spl set id		cbc67f03-55c4-4781-ba37-87c737b60282	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 may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis. Pediatric patients under age 12 should be supervised in the use of this product. Read directions carefully before using. Keep out of 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 reactions and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Sheffield Pharmaceuticals, LLC at 1-800-222-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reported adverse events (FAERS/openFDA)#

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