PreviDent Fresh Mint Sodium Fluoride 5 mg/g Gel, Dentifrice
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Caries prophylactic agents class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
PreviDent Fresh Mint is a prescription fluoride gel applied directly to the teeth. It contains sodium fluoride, a mineral compound commonly used in dental products to help strengthen tooth enamel and reduce cavity risk. This product is marketed without an approved FDA application.
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII D9OM4SK49P
Cetylpyridinium chloride is a chemical compound that acts as a preservative and antimicrobial agent in medicines. It helps prevent bacterial growth and extends the shelf life of liquid formulations.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII S38J6RZN16
Hydroxyethyl cellulose is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust product texture, and a film-former to create smooth coatings on tablets.
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UNII TUF2IVW3M2
Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
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UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Denta 5000 Plus 1.1 g/100g 16571-0814-50 | Rising | 51 g | $0.065 | — | Availability likely | — |
| Sodium Fluoride 5000 Plus 5 mg/g 69367-0309-51 | Westminster | 1 tube | $0.065 | — | Availability likely | — |
| SF 5000 Plus 5 mg/g 60258-0150-01 | Cypress | 1 tube | $0.093 | — | FDA listed | — |
| Sodium Fluoride 5000 ppm Fruit 6 mg/mL 11527-0730-44 | Sheffield | 1 tube | $0.097 | — | Availability likely | — |
| Sodium Fluoride 5000 ppm Spearmint 6 mg/mL 11527-0750-43 | Sheffield | 1 tube | $0.097 | — | Availability likely | — |
| Sodium Fluoride 5000 ppm Dry Mouth 6.1 mg/mL 11527-0755-34 | Sheffield | 1 tube | $0.097 | — | Availability likely | — |
| Sodium Fluoride 5000 PPM 6 mg/mL 69367-0311-01 | Westminster | 100 ml | $0.097 | — | Availability likely | — |
| Sodium Fluoride 5000 PPM 6 mg/mL 69367-0312-01 | Westminster | 100 ml | $0.097 | — | Availability likely | — |
| DentaGel 1.1 g/100g 16571-0815-60 | Rising | 56 g | $0.110 | — | Availability likely | — |
| Sodium Fluoride 1.1% Gel 5 mg/g 69367-0310-56 | Westminster | 1 tube | $0.110 | — | Availability likely | — |
| Sodium Fluoride Gel 5 mg/g 50268-0733-56 | AvPAK | 1 tube | $0.110 | — | Availability likely | — |
| Sodium Fluoride 1.1% 5 mg/g 35573-0435-56 | Burel | 1 tube | $0.110 | — | Availability likely | — |
| PreviDent 5000 Dry Mouth 6.1 mg/mL 00126-0016-61 | Colgate | 100 ml | — | — | FDA listed | — |
| PreviDent 5000 Booster Plus Fruitastic 6 mg/mL 00126-0072-92 | Colgate | 100 ml | — | — | FDA listed | — |
| PreviDent 5000 Booster Plus Spearmint 6 mg/mL 00126-0074-92 | Colgate | 100 ml | — | — | FDA listed | — |
| PreviDent Fresh Mint 5 mg/gthis 00126-0088-02 | Colgate | 1 tube | — | — | FDA listed | — |
| PreviDent 5000 Plus Fruitastic 11 mg/g 00126-0286-66 | Colgate | 1 tube | — | — | FDA listed | — |
| PreviDent 5000 Plus Spearmint 11 mg/g 00126-0287-66 | Colgate | 1 tube | — | — | FDA listed | — |
| PreviDent Very Berry 5 mg/g 00126-0288-02 | Colgate | 1 tube | — | — | FDA listed | — |
| PreviDent OrthoDefense 6 mg/mL 00126-0289-92 | Colgate | 100 ml | — | — | FDA listed | — |
| PreviDent 5000 Kids 6 mg/mL 00126-0311-92 | Colgate | 100 ml | — | — | FDA listed | — |
| Acclean Anti-Cavity 1.1 g/100g 00404-0173-04 | Henry | 1 tube | — | — | FDA listed | — |
| Sodium Flouride 5 mg/mL 42291-0741-51 | AvKARE | 1 tube | — | — | FDA listed | — |
| Clinpro 5000 5 mg/g 48878-3120-04 | Solventum | 1 tube | — | — | FDA listed | — |
| Clinpro 5000 5 mg/g 48878-3130-04 | Solventum | 1 tube | — | — | FDA listed | — |
| Clinpro 5000 5 mg/g 48878-3140-04 | Solventum | 1 tube | — | — | FDA listed | — |
| Just Right 5000 1.1 g/100g 57511-0001-01 | Elevate | 97 g | — | — | FDA listed | — |
| Just Right 5000 1.1 g/100g 57511-0002-01 | Elevate | 97 g | — | — | FDA listed | — |
| Just Right 5000 1.1 g/100g 57511-0003-01 | Elevate | 97 g | — | — | FDA listed | — |
| Allday 5000 1.1 g/100g 57511-0005-01 | Elevate | 2 tubes | — | — | FDA listed | — |
| FluoriMax 5000 1.1 g/100g 57511-0504-01 | Elevate | 96 g | — | — | FDA listed | — |
| PRO Gel 5000 Mint 5000 ug/g 61578-0215-01 | DENTAL | 68 g | — | — | FDA listed | — |
| PRO Gel 5000 Citrus 5000 ug/g 61578-0216-01 | DENTAL | 68 g | — | — | FDA listed | — |
| Neutramaxx 5000 Plus Turbo 1.1 g/112g 63783-0500-04 | Massco | 112 g | — | — | FDA listed | — |
| Neutramaxx 5000 Tcp 1.1 g/112g 63783-0501-04 | Massco | 112 g | — | — | FDA listed | — |
| Neutra Maxx 5000 1.428 g/120g 63783-0504-06 | Massco | 120 g | — | — | FDA listed | — |
| Prosys .11 g/100g 66975-0782-01 | Benco | 113 g | — | — | FDA listed | — |
| Super Mint Prescription 1.1 g/100g 83729-0102-10 | SuperMouth, | 1 tube | — | — | FDA listed | — |
| Super Chocolate Prescription 1.1 g/100g 83729-0103-10 | SuperMouth, | 1 tube | — | — | FDA listed | — |
| Fluoridex 5 mg/g 59883-0016-04 | DEN-MAT | 1 tube | — | — | FDA listed | — |
| Fluoridex 5 mg/g 59883-0020-04 | DEN-MAT | 1 tube | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00126-0088-02 You're viewing this | 1 TUBE in 1 CARTON (0126-0088-02) / 56 g in 1 TUBE | 2016-07-15 | Active |
🧭 About this NDC listing & data coverage
Listed without an FDA application
This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Is this NDC FDA-approved?
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Is the NDC printed on the package the same as the 11-digit billing NDC?
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Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE A dental caries preventive, for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 PreviDent® Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray.
This prescription dental gel should be used once daily following use of a regular toothpaste unless otherwise instructed by your dental professional.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Follow these instructions unless otherwise instructed by your dental professional: After brushing thoroughly with toothpaste, rinse as usual. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of gel to the teeth with a toothbrush or mouth trays once daily for at least one minute, preferably at bedtime. After use, adults expectorate gel.
For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16 years, expectorate gel after use and rinse mouth thoroughly.
⛔ Contraindications ▾
CONTRAINDICATIONS Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
⚠️ Warnings ▾
WARNINGS Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially in the areas with high fluoride concentration in drinking water. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel. Read directions carefully before using. Keep out of reach of infants and children.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Pregnancy Category B It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations.
There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.
🧒 Pediatric Use ▾
Pediatric Use The use of PreviDent® Gel in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11-14 years conducted by Englander, et al. 2,3,4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.
🧓 Geriatric Use ▾
Geriatric Use Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
🆘 Overdosage ▾
OVERDOSAGE Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours.
If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.
A treatment dose (a thin ribbon) of PreviDent® Gel contains approximately 2 mg fluoride. A 2 oz. tube contains approximately 266 mg fluoride.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Fresh Mint Very Berry 2 oz. (56 g) net wt. plastic tubes. NDC 0126-0088-02 NDC 0126-0288-02 STORAGE Store at controlled room temperature, 68-77°F (20-25°C).
📦 Storage and Handling ▾
STORAGE Store at controlled room temperature, 68-77°F (20-25°C).
📋 Description ▾
DESCRIPTION Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in pediatric patients and adults. This prescription product is not a dentifrice. Active Ingredient Sodium Fluoride 1.1% (w/v). Inactive Ingredients Cetylpyridinium chloride, flavor, hydroxyethycellulose, poloxamer 407, sodium saccharin, sorbitol, titanium dioxide, water, FD&C blue no. 1 (FreshMint only), FD&C red no. 40 (Very Berry only)