UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE

Manufacturer
Universal Distribution Center LLC
Effective date
2023-11-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:32

Label at a glance#

ProductUNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Potassium Nitrate  5%

Sodium Fluoride- 0.32% (0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

Purpose

Antihypersensitivity

Anticavity

INDICATIONS & USAGE SECTION

Uses

  • builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact.
  • aids in the prevention of dental cavities.

WARNINGS SECTION

Warning

OTC - WHEN USING SECTION

When using this product

  • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.

OTC - STOP USE SECTION

Stop and ask a dentist

  • if the problem persists or worsens.

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

  • If accidentally swallowed more than used for brushing, seek professional help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years of age and older
  • apply at least a 1-inch strip of product onto soft bristle toothbrush
  • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times day, or as recommended by a dentist or doctor.
  • make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

Children under 12 years of age: Consult a dentist or doctor.

SPL UNCLASSIFIED SECTION

Other information

  • store in a cool, dry place.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Sorbitol, Water, Silica, Sodium lauryl sulfate, Xanthan gum, Sodium saccharin, Sodium benzoate, Sodium carboxy methyl cellulose, Titanium dioxide, Flavor, D&C yellow#10, FD&C blue#1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE TOOTHPASTE

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038841potassium nitrate 5 % / sodium fluoride 0.15 % ToothpastePSN2
1038841potassium nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG ToothpasteSCD2
1038841K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG ToothpasteSY2
1038841pot nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG gel ToothpasteSY2
1038841Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG ToothpasteSY2
1038841potassium nitrate 5 % / sodium fluoride 0.15 % ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-109-01UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE122 g in 1 TUBEPASTE1222

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-109UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [UNIVERSAL DISTRIBUTION CENTER LLC]2Current NDC, Legacy NDC, 1 package rows20231121_fcf59439-7e06-4129-a89f-cdeecdf8d488.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52000-10952000-109-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDEPOTASSIUM NITRATE AND SODIUM FLUORIDEUniversal Distribution Center LLCfcf59439-7e06-4129-a89f-cdeecdf8d4882023-11-17WarningsExact identifier
ndc (package): 52000-109-01
ndc (product): 52000-109
ndc11 (package): 52000010901
spl id: 1199f2f8-98e4-4b76-9be9-3b921495a3c3
spl set id: fcf59439-7e06-4129-a89f-cdeecdf8d488

Reported adverse events (FAERS/openFDA)#

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