Sodium Fluoride 5000 ppm Enamel Protect

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 Enamel Protect
Generic name: SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%
Manufacturer: Sheffield Pharmaceuticals LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 83dfdead-4f71-404e-90ae-dbd6849c7cf1
SPL ID: 3fa71e96-0c84-4ce6-8aa8-6689b876c480
Version: 1
Effective date: 2021-01-04
Source export date: 2026-10-12
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:26:03

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 Enamel Protect	openfda.brand_name
generic name		SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%	openfda.generic_name
manufacturer name		Sheffield Pharmaceuticals LLC	openfda.manufacturer_name
ndc	package	11527-745-34	openfda.package_ndc
ndc	product	11527-745	openfda.product_ndc
ndc11	package	11527074534	derived:openfda.package_ndc
spl id		3fa71e96-0c84-4ce6-8aa8-6689b876c480	id
spl set id		83dfdead-4f71-404e-90ae-dbd6849c7cf1	set_id
unii		8ZYQ1474W7	openfda.unii
unii		RU45X2JN0Z	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: Not for systemic treatment- DO NOT SWALLOW. Keep out of the reach of infants and children. Children under 12 years of age, consult a dentist or physician. Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

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.