FDA.reportPublic FDA data

Opal™ by Opalescence

Manufacturer
Ultradent Products, Inc.
Effective date
2026-09-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-09-12 01:01:27

Label at a glance#

ProductOpal by Opalescence Sensitivity
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure9 sections

Indications and uses

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

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Potassium Nitrate 5% w/wAntihypersensitivity
Sodium Fluoride 0.25% w/wAnticavity

Uses

INDICATIONS & USAGE SECTION

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

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 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

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

Water (Aqua), Silica, Xylitol, Glycerin, Sorbitol, Poloxamer 407, Methyl Salicylate (flavor), Sodium Lauryl Sulfate, Carbomer, Cool Mint Flavor, FD&C Blue #1 (CI 42090), FD&C Yellow #5 (CI 19140), Wintermint Flavor, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xantham Gum

Questions or comments

OTC - QUESTIONS SECTION

Call toll-free 1.800.496.8330

PRINCIPAL DISPLAY PANEL - 4.7 OZ Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

opal™
by Opalescence ®

Whitening
Toothpaste

SENSITIVITY
RELIEF

COOL MINT

FLUORIDE TOOTHPASTE
NET WT. 4.7 OZ

PRINCIPAL DISPLAY PANEL - 4.7 OZ Tube Carton
PRINCIPAL DISPLAY PANEL - 4.7 OZ Tube Carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix1011643AR02opal-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51206-311-012024-01-30C16284748780-11030e365-63b5-111a-e063-dadaa90a10e2Opal™ by Opalescence ® Sensitivity
51206-311-012024-01-30C16284748780-11030e365-63b5-111a-e063-dadaa90a10e2Opal™ by Opalescence ® Sensitivity
51206-311-022024-01-30C16284748780-11030e365-63b5-111a-e063-dadaa90a10e2Opal™ by Opalescence ® Sensitivity
51206-311-022024-01-30C16284748780-11030e365-63b5-111a-e063-dadaa90a10e2Opal™ by Opalescence ® Sensitivity

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51206-31151206-311-02, 51206-311-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SILICON DIOXIDEETJ7Z6XBU4IACT
XYLITOLVCQ006KQ1EIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
POLOXAMER 407TUF2IVW3M2IACT
METHYL SALICYLATELAV5U5022YIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM HYDROXIDE55X04QC32IIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-06-17full-release2026-06-01 01:03:21

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
Opal by Opalescence SensitivityPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.5ffc0d14-0290-47bb-90e5-90a25a5acc282026-09-09WarningsExact identifier
ndc (package): 51206-311-02
ndc (package): 51206-311-01
ndc (product): 51206-311
ndc11 (package): 51206031101
ndc11 (package): 51206031102
spl id: 5b14ee76-2fcb-639e-e063-6294a90a9211
spl set id: 5ffc0d14-0290-47bb-90e5-90a25a5acc28

Reported adverse events (FAERS/openFDA)#

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