FDA.reportPublic FDA data

Vortex

Manufacturer
DSC Laboratories, Div. of DSC Products Inc.
Effective date
2011-12-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:28

Label at a glance#

ProductVortex
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

Twist off cap and remove foil seal Adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or use as directed by dentist. Do not swallow To minimize swallowing use a pea-sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 yrs.: ask a dentist

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.20%

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in prevention of dental decay.

WARNINGS SECTION

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Twist off cap and remove foil seal
  • Adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or use as directed by dentist.
  • Do not swallow
  • To minimize swallowing use a pea-sized amount in children under 6.
  • Supervise children's brushing until good habits are established.
  • Children under 2 yrs.: ask a dentist

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, Glycerin, Xylitol, Hydrated Silica, Carbomer Homopolymer Type C, Natural Grape Flavor, Xanthan Gum, D and C Red #28, FD and C Blue #1, D and C Red #33.

Questions?

OTC - QUESTIONS SECTION

Call 1-314-436-3332

VORTEX TOOTHPASTE 120G TUBE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vortex Anti-Cavity Fluoride  Toothpaste

Net Wt. 4.2 oz (120g)

Distributed by: Wright Toothpaste Inc.

St. Louis, MO 63127

VORTEX TOOTHPASTE 120G TUBEVORTEX TOOTHPASTE 120G TUBE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1235783sodium fluoride 0.2 % ToothpastePSN1
1235783sodium fluoride 0.002 MG/MG ToothpasteSCD1
1235783sodium fluoride 0.2 % ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52316-028-422020-01-31C16284748780-19d75b9d1-082e-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52316-028-42Vortex120 g in 1 TUBEPASTE, DENTIFRICE1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52316-028VORTEX (TOOTHPASTE) PASTE, DENTIFRICE [DSC LABORATORIES, DIV. OF DSC PRODUCTS INC.]1Legacy NDC, 1 package rows20111230_47aef72b-2f09-4d08-b2d2-01b32e9e9faf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W71
FLUORIDE IONACTIVE MOIETYQ80VPU408O1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52316-02852316-028-42

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
XYLITOLVCQ006KQ1EIACT
HYDRATED SILICAY6O7T4G8P9IACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
XANTHAN GUMTTV12P4NEEIACT
D&C RED NO. 28767IP0Y5NHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8ecf77c1-f102-4992-a08e-6f3d42a6036b47aef72b-2f09-4d08-b2d2-01b32e9e9faf2011-12-06WarningsExact identifier
spl id: 8ecf77c1-f102-4992-a08e-6f3d42a6036b
spl set id: 47aef72b-2f09-4d08-b2d2-01b32e9e9faf

Reported adverse events (FAERS/openFDA)#

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