FDA.reportPublic FDA data

Opalescence Sensitivity Relief

Manufacturer
Ultradent Products, Inc.
Effective date
2026-10-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-13 04:02:55

Label at a glance#

ProductOpalescence Sensitivity Relief Whitening
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure11 sections

Indications and uses

Aids in the prevention of dental cavities. Helps reduce painful sensitivity of the teeth to cold, heat, acides, sweets, or contact.

Dosage and administration

Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristly toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or doctor.

Storage and handling

Do not use if tamper-evident seal is broken Store at room temperature Contains FD&C Yellow No. 5 (tartrazine) as a color additive

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium Nitrate 5% w/w

Sodium Fluoride 0.24% w/w

Purpose

OTC - PURPOSE SECTION

Antihypersensitivity

Anticavity

Uses

INDICATIONS & USAGE SECTION

  • Aids in the prevention of dental cavities.
  • Helps reduce painful sensitivity of the teeth to cold, heat, acides, sweets, or contact.

Warnings

WARNINGS SECTION

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 doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristly toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth.
  • Children under 12 years of age: Consult a dentist or doctor.

Other Information

STORAGE AND HANDLING SECTION

  • Do not use if tamper-evident seal is broken
  • Store at room temperature
  • Contains FD&C Yellow No. 5 (tartrazine) as a color additive

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Silica, Xylitol, Glycerin, Sorbitol, Poloxamer 407, Methyl Salicylate, Sodium Lauryl Sulfate, Carbomer, FD&C Yellow No. 5 (CI 19140), Flavor (Aroma), Sodium Benzoate, Sodium Hydroxide, Sucralose, Xanthan Gum

Questions or comments

OTC - QUESTIONS SECTION

Call toll-free 1.800.552.5512

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Opalescence Whitening Toothpaste

Sensitivity Relief

Cool Mint

Fluoride Toothpaste CartonCarton

NET WT. 4.7oz

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
51206-45151206-451-01, 51206-451-02, 51206-451-03, 51206-451-04, 51206-451-05

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
GLYCERINPDC6A3C0OXIACT
METHYL SALICYLATELAV5U5022YIACT
XYLITOLVCQ006KQ1EIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM BENZOATEOJ245FE5EUIACT

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Opalescence Sensitivity Relief WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.b5176a84-76a3-4ad0-a2e2-4997a12da9a52026-09-09WarningsName fallback
brand name: Opalescence Sensitivity Relief Whitening
Sensitivity Relief Fluoride FreePOTASSIUM NITRATEHealth and Natural Beauty USA Corpc23b2a83-ebc3-4bcf-a216-7693944dcfa02026-05-22WarningsName fallback
generic name: POTASSIUM NITRATE
Spring Gene Oil Pulling SensitivityPOTASSIUM NITRATEHealth and Natural Beauty USA Corp294051e3-69ec-4190-8b03-fa34988376b72026-02-26WarningsName fallback
generic name: POTASSIUM NITRATE
GuruNanda SensitivePOTASSIUM NITRATEGURUNANDA, LLC3ef0d3d4-fd42-0181-e063-6394a90af09c2026-01-19WarningsName fallback
generic name: POTASSIUM NITRATE
Boka SensitivePOTASSIUM NITRATEKaraka LLC40be9fab-53db-c67a-e063-6394a90a48cb2025-10-23WarningsName fallback
generic name: POTASSIUM NITRATE
SprinJene Natural Sensitivity and GumPOTASSIUM NITRATEHealth and Natural Beauty USA Corp3cb23e36-0e8c-4172-b4ae-859b58a2739f2025-07-07WarningsName fallback
generic name: POTASSIUM NITRATE
SENSODYNE Advanced Whitening PlusPOTASSIUM NITRATEHaleon US Holdings LLCf757ccdd-b316-4799-a34a-10edbb73da6b2024-07-12WarningsName fallback
generic name: POTASSIUM NITRATE
Attitude Adult Fluoride-free - Sensitive - SpearmintPOTASSIUM NITRATE9055-7588 Qubec Inc. DBA Attitude46d5c908-f0e3-444c-9d96-461feef391372024-05-14WarningsName fallback
generic name: POTASSIUM NITRATE
SENSODYNE Advanced WhiteningPOTASSIUM NITRATEHaleon US Holdings LLCa06e2549-3c4e-4818-b53e-1dea6828219f2024-03-04WarningsName fallback
generic name: POTASSIUM NITRATE

Reported adverse events (FAERS/openFDA)#

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