FDA.reportPublic FDA data

Opalescence™ Whitening Toothpaste Sensitivity Relief

Manufacturer
Ultradent Products, Inc. | Ultradent Products, Inc
Effective date
2026-09-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-09-12 01:01:32

Label at a glance#

ProductOpalescence Whitening Sensitivity Relief
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure10 sections

Indications and uses

Aids in the prevention of dental cavities Helps reduce painful sensitivity of the teeth to cold, heat, acids, 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 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 yeasrs 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, acids, 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 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 yeasrs 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 Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140), Flavor (Aroma), Sodium Benzoate, Sodium Hydroxide, Sucralose, Xantham Gum

Questions or comments

OTC - QUESTIONS SECTION

Call toll-free 1.800.552.5512

Principal Display Panel - 4.7 oz Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Opalescence Whitening Toothpaste

Sensitivity Relief

Cool Mint

NET WT. 4.7 oz * 133 g 8 100 ml

FLUORIDE TOOTHPASTE

FOR SENSITIVE TEETH Opalescence Whitening Toothpaste Sensitivity Relief_4.7 oz Tube CartonOpalescence Whitening Toothpaste Sensitivity Relief_4.7 oz Tube Carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix1007645AR07Opalescence Whitening Toothpaste Sensitivity Relief_4.7 oz Tube Carton.jpg

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
51206-31551206-315-01, 51206-315-02, 51206-315-03, 51206-315-04, 51206-315-05

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
SODIUM FLUORIDE8ZYQ1474W7ACTIM
POTASSIUM NITRATERU45X2JN0ZACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
CARBOMER0A5MM307FCIACT
SODIUM LAURYL SULFATE368GB5141JIACT
POLOXAMER 407TUF2IVW3M2IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
SORBITOL506T60A25RIACT
METHYL SALICYLATELAV5U5022YIACT
XYLITOLVCQ006KQ1EIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM HYDROXIDE55X04QC32IIACT
AQUA059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-04-06full-release2026-06-01 01:52:44
12025-12-01monthly-update2026-06-03 17:45:35

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
Opalescence Whitening Sensitivity ReliefPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.44e94663-895b-67da-e063-6394a90a5fe62026-09-09WarningsExact identifier
ndc (package): 51206-315-02
ndc (package): 51206-315-01
ndc (package): 51206-315-05
ndc (package): 51206-315-04
ndc (package): 51206-315-03
ndc (product): 51206-315
ndc11 (package): 51206031505
ndc11 (package): 51206031504
ndc11 (package): 51206031501
ndc11 (package): 51206031503
ndc11 (package): 51206031502
spl id: 5b14ca86-96a0-7c20-e063-6394a90af5bd
spl set id: 44e94663-895b-67da-e063-6394a90a5fe6

Reported adverse events (FAERS/openFDA)#

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