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Over-the-counter medicine · no prescription needed

Potassium nitrite and sodium fluoride

Purpose on the label: Antihypersensitivity Anticavity

Mouth and teeth

Official FDA data, not advice

The label text is quoted exactly as the company filed it with the U.S. Food and Drug Administration (FDA), with a link to the official copy. The list of brands comes from the FDA NDC Directory.

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

If someone may have taken too much, call Poison Help: 1‑800‑222‑1222. In an emergency, call 911.

Quick answers

What is Potassium nitrite and sodium fluoride used for?
The Drug Facts label of CVS Pharmacy Enamel Guard (CVS Pharmacy) lists these uses: Directions Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbruch. brush teeth thorughly for at least one minute for at least twice a day (morning and evening), and not more than 3 times a day, or as directed 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 of age: Consult a dentist or doctor..
Do I need a prescription for Potassium nitrite and sodium fluoride?
No. The products on this page are sold without a prescription (over the counter).
Is a store brand the same as the name brand?
Products listed together below have the same active ingredients, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
Has Potassium nitrite and sodium fluoride been recalled?
No recall linked to these products appears in the FDA enforcement reports we use.

Drug Facts label

Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.

CVS Pharmacy Enamel Guard · CVS Pharmacy

Potassium nitrite 5% · Sodium fluoride 0.15%, paste, dentifrice (dental)

Active ingredient

Potassium Nitrate 5%......................................................................Antihypersensitivity Sodium Fluoride 0.24% (0.15% w/v fluoride ion)...........................................Anticavity

Purpose

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

Uses

Directions Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbruch. brush teeth thorughly for at least one minute for at least twice a day (morning and evening), and not more than 3 times a day, or as directed 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 of age: Consult a dentist or doctor.

Warnings

When using this product

if irritaiton occurs discontinue use.

Keep out of reach of children

If more than used for brushing is accidentally swallowed, get medical help of contact a Posion Control Center right away. 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.

Directions

Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbruch.

Other information

Store in a cool dry place. Keep tube capped when not in use.

Inactive ingredients

water, hydrated silica, sorbitol, glycerin, PEG-8, cocamidpropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

— FDA label of CVS Pharmacy Enamel Guard, CVS Pharmacy, effective November 21, 2025. See the official label on DailyMed →

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

Same medicine, other brands

Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.

Potassium nitrite 5% · Sodium fluoride 0.15% · paste, dentifrice (dental) · 2 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
CVS Pharmacy Enamel Guard CVS Pharmacy DailyMed
Rite Aid Enamel Guard Rite Aid DailyMed

Companies that sell this medicine

The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.

  • CVS Pharmacy1 product
  • Rite Aid1 product

Recalls

No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. FDA rule for the Drug Facts label (21 CFR 201.66)

Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.

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