FLUORIDEX Sodium Fluoride 50 mg/g; 5 mg/g Paste, Dentifrice, 24 g
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Fluoridex is a prescription toothpaste containing sodium fluoride and potassium nitrate. Sodium fluoride is commonly used in dental products to help strengthen tooth enamel and reduce cavities. Potassium nitrate is typically included in toothpastes designed to address tooth sensitivity. This product is marketed as an unapproved drug and has not received FDA approval.
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 |
|---|---|---|---|---|---|---|
| Sodium Fluoride 5000 ppm Sensitive 5.8 mg/mL; 57.5 mg/mL 11527-0704-42 | Sheffield | 1 tube | $0.118 | — | Availability likely | — |
| Sodium Fluoride 5000 ppm Enamel Protect 57.5 mg/mL; 5.8 mg/mL 11527-0745-34 | Sheffield | 1 tube | $0.118 | — | Availability likely | — |
| Denta 5000 Plus Sensitive 5.8 mg/mL; 57.5 mg/mL 16571-0823-10 | Rising | 100 ml | $0.118 | — | Availability likely | — |
| Sodium Fluoride and Potassium Nitrate 5.8 mg/mL; 57.5 mg/mL 69367-0318-01 | Westminster | 1 tube | $0.118 | — | Availability likely | — |
| PreviDent 5000 Enamel Protect 5.8 mg/mL; 57.5 mg/mL 00126-0022-92 | Colgate | 100 ml | — | — | FDA listed | — |
| PreviDent 5000 Sensitive 5.8 mg/mL; 57.5 mg/mL 00126-0070-61 | Colgate | 100 ml | — | — | FDA listed | — |
| Acclean Anti-Cavity Sensitivity Relief 5 g/100g; 1.1 g/100g 00404-0174-04 | Henry | 1 tube | — | — | FDA listed | — |
| Ionite H 1.1 mg/100g; 5 mg/100g 53045-0280-04 | Dharma | 122 g | — | — | FDA listed | — |
| Ionite H 1.1 mg/100g; 5 mg/100g 53045-0281-04 | Dharma | 122 g | — | — | FDA listed | — |
| FluoriMax 5000 Sensitive 1.1 g/100g; 5 g/100g 57511-0503-01 | Elevate | 96 g | — | — | FDA listed | — |
| Fluoridex 5 mg/g; 50 mg/g 59883-0030-04 | DENT-MAT | 1 tube | — | — | FDA listed | — |
| Fluoridex 50 mg/g; 5 mg/gthis 59883-0031-05 | DENT-MAT | 24 g | — | — | FDA listed | — |
| Pro-Sys 5 g/100g; 1.1 g/100g 66975-0778-01 | Benco | 113 g | — | — | FDA listed | — |
| Pro-Sys 1.1 g/100g; 5 g/100g 66975-0779-01 | Benco | 113 g | — | — | 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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 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 |
|---|---|---|---|
| 59883-0031-04 | 1 TUBE in 1 BOX (59883-031-04) / 112 g in 1 TUBE | 2016-12-21 | Active |
| 59883-0031-05 You're viewing this | 24 g in 1 TUBE (59883-031-05) | 2018-08-22 | Active |
Pack size FAQ
What quantity is in NDC 59883-0031-05?
What NDC number is used to bill for this package of FLUORIDEX Sodium Fluoride 50 mg/g; 5 mg/g Paste, Dentifrice?
🧭 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 | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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?
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Fluoridex toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Follow these instructions or use as instructed by a dental professional.• Adults and children age 6 or older, apply a thin ribbon or pea-sized amount of Fluoridex toothpaste to a toothbrush and brush thoroughly on all tooth surfaces for at least one minute. After use: • Adults should expectorate. For best results, do not eat, drink, or rinse for 30 minutes. • Children, age 6 to 16, should expectorate after use and rinse mouth thoroughly. • Use twice daily as your normal dentifrice or as directed by your dental professional.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 3 DOSAGE FORMS AND STRENGTHS • Daily Defense Mint: Green toothpaste containing 1.1% Sodium Fluoride (Mint). (3) • Daily Defense Fruit: Pink toothpaste containing 1.1% Sodium Fluoride (Fruit). (3) • Enhanced Whitening Mint: Green toothpaste containing 1.1% Sodium Fluoride (Mint). (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Do not use in children under 6 years of age unless recommended by a dentist or physician.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS DO NOT SWALLOW. • 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. • Prolonged daily ingestion may result in various degrees of dental fluorosis in children with developing dentition, especially if the water fluoridation exceeds 0.6 ppm, since younger children frequently cannot perform the brushing process without significant swallowing. • Use in children under age 6 years requires special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis. • Read directions carefully before using. • Keep out of reach of infants and children. • 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 physician.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have rarely been reported.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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 tissues. 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 or well controlled clinical 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.
8.3Nursing Mothers It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight).
No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.
8.4Pediatric Use The use of Fluoridex toothpaste in children age 6-16 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.2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Prescribing physicians and dentists should consider total fluoride exposure (dental care plus food, water, and other sources) when prescribing the product for use in children. Please refer to the CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS sections.
8.5Geriatric Use Subjects referenced in clinical studies of 1.1% (w/v) sodium fluoride, included 15 percent age 65 and over, with 1 percent age 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger clients, 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 clients with impaired renal function. Because elderly clients 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 ▾
10 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY A treatment dose (a thin ribbon) of Fluoridex 5000 ppm sodium fluoride toothpaste contains 2.5 mg fluoride. A 4 oz. tube contains 566 mg fluoride. 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 ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 4 oz. (112 g) net wt. tube • Daily Defense Mint NDC 59883-016-04 • Daily Defense Fruit NDC 59883-015-04 • Enhanced Whitening Mint NDC 59883-020-04 Store at controlled room temperature 15°-30° C (59°-86° F)
📋 Description ▾
11 DESCRIPTION Fluoridex toothpaste is a self-applied topical fluoride dentifrice containing 1.1% (w/w) sodium fluoride for the prevention and control of dental caries. Daily Defense Mint: Each gram contains 5 mg of fluoride ion in a neutral pH base, consisting of Cellulose Gum, D&C Yellow No. 10, FD&C Blue No.
1, Flavor, Glycerin, Mica (and) Titanium Dioxide, Poloxamer 234, Silica, Sodium Laurel Sulfate, Sodium Saccharin, Sorbitol, Water, Xylitol. Daily Defense Fruit: Each gram contains 5 mg of fluoride ion in a neutral pH base, consisting of Cellulose Gum, D&C Red No. 33, Flavor, Glycerin, Mica (and) Titanium Dioxide, Poloxamer 234, Silica, Sodium Laurel Sulfate, Sodium Saccharin, Sorbitol, Water, Xylitol.
Enhanced Whitening Mint: Each gram contains 5 mg of fluoride ion in a neutral pH base, consisting of Cellulose Gum, D&C Yellow No. 10, FD&C Blue No. 1, Flavor, Glycerin, Mica (and) Titanium Dioxide, Poloxamer 234, Silica, Sodium Laurel Sulfate, Sodium Saccharin, Sorbitol, Water, Xylitol.