Drugplain

Sensodyne Pronamel Strong and Bright Enamel Extra Fresh 50 mg/g

potassium nitrate and sodium fluoride · PASTE · Haleon US Holdings LLC

No Recall HistoryCurrently in Shortage
Plain English

Sensodyne Pronamel Strong and Bright is a toothpaste containing potassium nitrate and sodium fluoride that helps protect tooth enamel and reduce tooth sensitivity. This over-the-counter product is applied by brushing teeth as part of your daily oral hygiene routine.

Key Facts

Brand Name
Sensodyne Pronamel Strong and Bright Enamel Extra Fresh
Generic Name
potassium nitrate and sodium fluoride
NDC Code (Product)
0135-0603
Manufacturer
Haleon US Holdings LLC
Strength
50 mg/g
Dosage Form
PASTE
Route
ORAL
Marketing Status
Application #
M022
Marketing Start
12/19/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

oral discomfort9 reports
burn oral cavity6 reports
hyperaesthesia teeth6 reports
drug effective for unapproved indication5 reports
gingival pain4 reports
oral pain4 reports
product complaint4 reports
product use in unapproved indication4 reports
choking3 reports
cough3 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.

Dosage & Administration

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), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years Consult a dentist or doctor.

Warnings

Warnings When using this product, if irritation occurs discontinue use. Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use. Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Sensodyne Pronamel Strong and Bright Enamel Extra Fresh used for?

Sensodyne Pronamel Strong and Bright is a toothpaste containing potassium nitrate and sodium fluoride that helps protect tooth enamel and reduce tooth sensitivity. This over-the-counter product is applied by brushing teeth as part of your daily oral hygiene routine.

Is Sensodyne Pronamel Strong and Bright Enamel Extra Fresh a controlled substance?

Sensodyne Pronamel Strong and Bright Enamel Extra Fresh is not classified as a controlled substance by the DEA.

What is the generic name for Sensodyne Pronamel Strong and Bright Enamel Extra Fresh?

The generic name for Sensodyne Pronamel Strong and Bright Enamel Extra Fresh is potassium nitrate and sodium fluoride. There are 12 other brand versions of potassium nitrate and sodium fluoride.

What is the NDC code for Sensodyne Pronamel Strong and Bright Enamel Extra Fresh 50 mg/g?

The NDC (National Drug Code) for Sensodyne Pronamel Strong and Bright Enamel Extra Fresh 50 mg/g is 0135-0603, listed by Haleon US Holdings LLC.

Product NDC

0135-0603

Package NDC

0135-0603-01

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)