SF 5000 Plus

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: SF 5000 Plus
Generic name: 1.1% SODIUM FLUORIDE PRESCRIPTION DENTAL CREAM
Manufacturer: Cypress Pharmaceutical, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: fa625ece-d873-491a-8d45-2833b64e5425
SPL ID: ae70d9a8-5a8b-4a25-8357-0c475a100fef
Version: 2
Effective date: 2016-07-01
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:39:17

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		SF 5000 Plus	openfda.brand_name
generic name		1.1% SODIUM FLUORIDE PRESCRIPTION DENTAL CREAM	openfda.generic_name
manufacturer name		Cypress Pharmaceutical, Inc.	openfda.manufacturer_name
ndc	package	60258-150-01	openfda.package_ndc
ndc	product	60258-150	openfda.product_ndc
ndc11	package	60258015001	derived:openfda.package_ndc
rxcui		392038	openfda.rxcui
spl id		ae70d9a8-5a8b-4a25-8357-0c475a100fef	id
spl set id		fa625ece-d873-491a-8d45-2833b64e5425	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 the dental cream which could cause dental fluorosis. Read directions carefully before using. If using a mouthpiece application, prolonged exposure (longer than 1 minute) may result in oral irritation, such as burning. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSAGE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

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 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.