Indications and uses
Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. Aids in the prevention of dental cavities.
Opalescence™ Sensitivity Relief Whitening Toothpaste
- Manufacturer
- Ultradent Products, Inc.
- Effective date
- 2026-09-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 12
- Source
- daily-update
- Hydrated at
- 2026-09-12 01:01:39
Label at a glance#
ProductOpalescence Sensitivity Relief Whitening
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure10 sections
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 bristle 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
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active Ingredients | Purpose |
|---|---|
| Potassium Nitrate 5% w/w | Antihypersensitivity |
| Sodium Fluoride 0.25% w/w | Anticavity |
Uses
- Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
- Aids in the prevention of dental cavities.
Warnings
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
- Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle 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
- 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
Water (Aqua), Silica, Xylitol, Glycerin, Sorbitol, Flavor (Aroma), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xanthan Gum, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140)
Questions or comments
Call toll-free 1.800.552.5512
SPL UNCLASSIFIED SECTION
Manufactured by:Ultradent Products, Inc., South Jordan, UT 84095, USA
PRINCIPAL DISPLAY PANEL - 133 g Tube Carton
Opalescence™
whitening toothpaste
Cool Mint
Sensitivity
Relief
NET WT. 4.7 oz • 133 g • 100 ml
FLUORIDE TOOTHPASTE
FOR SENSITIVE TEETH
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Data Matrix | 1009125AR01 | opalescence-01.jpg |
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Potassium Nitrate | ACTIVE INGREDIENT | RU45X2JN0Z | 1 | |
| Sodium Fluoride | ACTIVE INGREDIENT | 8ZYQ1474W7 | 1 | |
| Fluoride Ion | ACTIVE MOIETY | Q80VPU408O | 1 | |
| Nitrate Ion | ACTIVE MOIETY | T93E9Y2844 | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Methyl Salicylate | INACTIVE INGREDIENT | LAV5U5022Y | 1 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Sodium Benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| Sodium Lauryl Sulfate | INACTIVE INGREDIENT | 368GB5141J | 1 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| Sucralose | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| Xanthan Gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 | |
| Xylitol | INACTIVE INGREDIENT | VCQ006KQ1E | 1 |
Products#
Every source-derived product name is available through these pages.
- Opalescence Sensitivity Relief Whitening
- Potassium Nitrate and Sodium Fluoride
- POTASSIUM NITRATE
- NITRATE ION
- SODIUM FLUORIDE
- FLUORIDE ION
- GLYCERIN
- XANTHAN GUM
- WATER
- SORBITOL
- SODIUM HYDROXIDE
- XYLITOL
- SODIUM BENZOATE
- SUCRALOSE
- SILICON DIOXIDE
- METHYL SALICYLATE
- SODIUM LAURYL SULFATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51206-308 | 51206-308-01, 51206-308-05, 51206-308-02, 51206-308-03, 51206-308-04, 51206-308-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POTASSIUM NITRATE | RU45X2JN0Z | ACTIB |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| GLYCERIN | PDC6A3C0OX | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 11 | 2025-11-17 | full-release | 2026-06-01 01:16:48 |
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | GRANULE / ORAL | 5.4 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | TABLET, ORALLY DISINTEGRATING / ORAL | 60 mg | ||
| Methyl Salicylate | METHYL SALICYLATE | LAV5U5022Y | PASTE, DENTIFRICE / DENTAL | 1.1 %w/w | ||
| Xylitol | XYLITOL | VCQ006KQ1E | SOLUTION / ORAL | 21600 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | TABLET / ORAL | 15.04 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | LOZENGE / ORAL | 1264 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | FILM, SOLUBLE / ORAL | 29 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SUSPENSION / ORAL | 400 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | SOLUTION / ORAL | 21600 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / RECTAL | 452 mg | ||
| Sodium Lauryl Sulfate | SODIUM LAURYL SULFATE | 368GB5141J | GEL / DENTAL | 1.47 %w/w | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION/ DROPS / ORAL | 22 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| Xylitol | XYLITOL | VCQ006KQ1E | TABLET, EXTENDED RELEASE / ORAL | 2752 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET / ORAL | 56 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | FILM, SOLUBLE / ORAL | 33 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | SOLUTION / ORAL | 21600 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | PASTE / ORAL | 1050 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | TABLET / SUBLINGUAL | 12 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | SPRAY / NASAL | 2 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | GEL / TOPICAL | 58 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | TABLET / ORAL | 15.04 mg | ||
| Sodium Lauryl Sulfate | SODIUM LAURYL SULFATE | 368GB5141J | PASTE / DENTAL | 1.5 %w/w | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 6 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | LOZENGE / ORAL | 1264 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | GEL / TOPICAL | 58 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | GRANULE, FOR SUSPENSION / ORAL | 23 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | TABLET, ORALLY DISINTEGRATING / ORAL | 360 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION / ORAL | 383 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / RECTAL | 452 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, FILM COATED / ORAL | 0.08 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | TABLET, FOR SUSPENSION / ORAL | 65 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | TABLET, ORALLY DISINTEGRATING / ORAL | 360 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | ENEMA / RECTAL | 150 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SOLUTION / ORAL | 84 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION, EXTENDED RELEASE / ORAL | 16 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 2350 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | POWDER, FOR SUSPENSION / ORAL | 4223 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | TROCHE / ORAL | 60 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| Sodium Lauryl Sulfate | SODIUM LAURYL SULFATE | 368GB5141J | PASTE, DENTIFRICE / DENTAL | 1.4 %w/w | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SOLUTION / ORAL | 10 mg/5ml | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.6 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, EXTENDED RELEASE / ORAL | 528 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | TABLET / ORAL | 15.04 mg | ||
| Sodium Lauryl Sulfate | SODIUM LAURYL SULFATE | 368GB5141J | PASTE / DENTAL | 1.5 %w/w | ||
| Methyl Salicylate | METHYL SALICYLATE | LAV5U5022Y | POWDER, DENTIFRICE / DENTAL | NA | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 36 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | LOZENGE / ORAL | 1264 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Opalescence Sensitivity Relief Whitening | POTASSIUM NITRATE AND SODIUM FLUORIDE | Ultradent Products, Inc. | b5176a84-76a3-4ad0-a2e2-4997a12da9a5 | 2026-09-09 | Warnings | 51206-308-03 51206-308-05 51206-308-06 51206-308-02 51206-308-01 51206-308-04 51206-308 51206030806 51206030801 51206030803 51206030804 51206030802 51206030805 5b14ddfe-ec8e-3a25-e063-6294a90afe5b b5176a84-76a3-4ad0-a2e2-4997a12da9a5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.