PreviDent 5000 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: PreviDent 5000 Enamel Protect
Generic name: SODIUM FLUORIDE AND POTASSIUM NITRATE
Manufacturer: Colgate Oral Pharmaceuticals, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: bbc66b1b-e05c-4e14-bef3-b8bae419fc89
SPL ID: 3b6e8b51-0682-4bce-9df3-bf3c62f132c2
Version: 9
Effective date: 2026-06-12
Source export date: 2026-10-12
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:29:06

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		PreviDent 5000 Enamel Protect	openfda.brand_name
generic name		SODIUM FLUORIDE AND POTASSIUM NITRATE	openfda.generic_name
manufacturer name		Colgate Oral Pharmaceuticals, Inc.	openfda.manufacturer_name
ndc	package	0126-0022-92	openfda.package_ndc
ndc	product	0126-0022	openfda.product_ndc
ndc11	package	00126002292	derived:openfda.package_ndc
spl id		3b6e8b51-0682-4bce-9df3-bf3c62f132c2	id
spl set id		bbc66b1b-e05c-4e14-bef3-b8bae419fc89	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 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.

Reported adverse events (FAERS/openFDA)#

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