Opal by Opalescence Sensitivity

Opal by Opalescence Sensitivity is an FDA-registered drug product whose active ingredient is POTASSIUM NITRATE AND SODIUM FLUORIDE. It is labelled by Ultradent Products, Inc. taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 51206-311, application M022, label effective 20260909. It is one of 6 FDA drug label records sharing the active ingredient POTASSIUM NITRATE AND SODIUM FLUORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing POTASSIUM NITRATE AND SODIUM FLUORIDE are most often described in connection with: helps reduce, painful sensitivity, teeth cold, heat acids, sweets contact, prevention dental. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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.

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. 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.

FDA lists 6 drug label records with POTASSIUM NITRATE AND SODIUM FLUORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Opal by Opalescence Sensitivity used for?
Uses Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. Aids in the prevention of dental cavities.

Who makes Opal by Opalescence Sensitivity?
Ultradent Products, Inc. is the labeler of record for Opal by Opalescence Sensitivity. 6 FDA label records share the active ingredient POTASSIUM NITRATE AND SODIUM FLUORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Opal by Opalescence Sensitivity come in?
administered by dental. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Opal by Opalescence Sensitivity prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing POTASSIUM NITRATE AND SODIUM FLUORIDE?
Yes. 6 FDA drug label records list POTASSIUM NITRATE AND SODIUM FLUORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Opal by Opalescence Sensitivity been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.