Sodium Fluoride Gel 5 mg/g Gel, Dentifrice
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
This is a prescription dental gel containing sodium fluoride at a concentration of 5 mg/g. Sodium fluoride is a fluoride salt typically used in dental products to help strengthen tooth enamel and reduce tooth decay risk. The gel form is applied directly to the teeth. This product is marketed without an approved FDA application.
Patient education
Supplement & herbal interactions
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🧪 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 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 PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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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 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 OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
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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 C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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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.
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UNII VCQ006KQ1E
Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.
9 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
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💲 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 | $0.110 | $6.15 / 56 g |
| Medicaid paysCMS SDUD · 12 mo | $0.4363 | $24.43 / 56 g |
| 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 |
|---|---|---|---|---|---|---|
| Sodium Fluoride 5000 Plus 5 mg/g 69367-0309-51 | Westminster | 1 tube | $0.065 | — | Availability likely | save 41% |
| Sodium Fluoride 1.1% 5 mg/g 35573-0435-56 | Burel | 1 tube | $0.110 | — | Availability likely | — |
| Sodium Fluoride Gel 5 mg/gthis 50268-0733-56 | AvPAK | 1 tube | $0.110 | — | Availability likely | — |
| Sodium Fluoride 1.1% Gel 5 mg/g 69367-0310-56 | Westminster | 1 tube | $0.110 | — | Availability likely | — |
| Sf 11 mg/g 60258-0151-01 | Cypress | 1 tube | $0.125 | — | FDA listed | +14% |
| Pcxx Anticaries No Flavor Ne G 11.1 mg/mL 62007-0835-16 | Ross | 473 ml | — | — | FDA listed | — |
| Sodium Fluoride 1.1% Dental Gel MINT 1.1 g/100g 71085-0074-02 | IPG | 1 tube | — | — | Discontinued | — |
| Sodium Fluoride 1.1% Dental Gel BUBBLEGUM 1.1 g/100g 71085-0079-02 | IPG | 1 tube | — | — | Discontinued | — |
| 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 | — |
| PreviDent Fresh Mint 5 mg/g 00126-0088-02 | Colgate | 1 tube | — | — | FDA listed | — |
| PreviDent Very Berry 5 mg/g 00126-0288-02 | Colgate | 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?
🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 50268-0733-56 You're viewing this | 1 TUBE in 1 CARTON (50268-733-56) / 56 g in 1 TUBE | 2022-05-09 | 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) | ✓ Available |
| 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) | ✓ Available |
Questions about this listing
Is this NDC FDA-approved?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Do I need a prescription for this product?
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. Sodium Fluoride 1.1% 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. May be used whether or not drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Follow these instructions unless otherwise instructed by your dental professional: Directions for daily use: 1. 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.
2. After use, adults expectorate gel. For the 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. Precaution: DO NOT SWALLOW.
⛔ 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 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel which could cause dental fluorosis. Read directions carefully before using.
If using a mouthpiece application, prolonged exposure (longer than 1 minute) may result in oral irritation, such as burning.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported. You should call your doctor, or dental professional for medical advice about serious adverse events. To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 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 NET WT. 2 oz. (56g) tube containing light blue, mint flavored dental gel. NDC 50268-733-56 STORAGE Store at Controlled Room Temperature, 20° - 25° C (68° - 77° F). KEEP THIS PRODUCT OUT OF REACH OF CHILDREN TAMPER EVIDENT: Do not use if foil seal is missing or damaged. Rx Only
📦 Storage and Handling ▾
STORAGE Store at Controlled Room Temperature, 20° - 25° C (68° - 77° F). KEEP THIS PRODUCT OUT OF REACH OF CHILDREN TAMPER EVIDENT: Do not use if foil seal is missing or damaged. Rx Only
📋 Description ▾
DESCRIPTION Self-topical neutral fluoride gel containing 1.1% (w/v) 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 FD&C Blue No. 1, glycerin, hydroxyethylcellulose, mint flavor, purified water, sodium benzoate, sodium saccharin, Sorbitol, xylitol.