Pro-Den Rx

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: Pro-Den Rx
Generic name: SODIUM FLUORIDE
Manufacturer: Den-Mat Holdings, Llc
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: ba020e07-ad41-4419-a503-f1245131b7d2
SPL ID: 6a0ff4f9-a7f9-1e75-e053-2991aa0a2782
Version: 2
Effective date: 2018-04-17
Source export date: 2026-09-28
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/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:13:06

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 · 9 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Pro-Den Rx	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		Den-Mat Holdings, Llc	openfda.manufacturer_name
ndc	package	59883-911-64	openfda.package_ndc
ndc	product	59883-911	openfda.product_ndc
ndc11	package	59883091164	derived:openfda.package_ndc
spl id		6a0ff4f9-a7f9-1e75-e053-2991aa0a2782	id
spl set id		ba020e07-ad41-4419-a503-f1245131b7d2	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 and cautions

Warnings and Precautions For Professional Office Use Only. This product is not intended for home or unsupervised consumer use. Do not swallow. Keep out of reach of children. Not recommended for children under the age of 6. Limited to topical use in the mouth only.

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 The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.

Reported adverse events (FAERS/openFDA)#

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