PreviDent Alcohol Free

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 Alcohol Free
Generic name: SODIUM FLUORIDE
Manufacturer: Colgate Oral Pharmaceuticals, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 28e4f7cd-9fd8-4c7a-9e4b-d747fefc76c0
SPL ID: 36206573-587a-4512-9efe-cc75f8af46c9
Version: 7
Effective date: 2026-06-17
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 02:28:44

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 · 9 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		PreviDent Alcohol Free	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		Colgate Oral Pharmaceuticals, Inc.	openfda.manufacturer_name
ndc	package	0126-0033-16	openfda.package_ndc
ndc	product	0126-0033	openfda.product_ndc
ndc11	package	00126003316	derived:openfda.package_ndc
spl id		36206573-587a-4512-9efe-cc75f8af46c9	id
spl set id		28e4f7cd-9fd8-4c7a-9e4b-d747fefc76c0	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 Keep out of reach of infants and children. Pediatric patients under age 12 should be supervised in the use of this product. Patients under age 6 require special supervision to prevent repeated swallowing of rinse since they frequently swallow significant amounts while rinsing. Prolonged daily ingestion may result in dental fluorosis in patients under age 6, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using. DO NOT USE IF PRINTED NECK BAND IS BROKEN OR MISSING

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS In patients with mucositis, gingival tissues may be hypersensitive to flavor present in formulation. Allergic reactions and other idiosyncrasies are rarely reported.

Reported adverse events (FAERS/openFDA)#

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