Acclean Anti-Cavity Sensitivity Relief POTASSIUM NITRATE, SODIUM FLUORIDE 5 g/100g; 1.1 g/100g Paste, Dentifrice, 1 tube
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Acclean Anti-Cavity Sensitivity Relief is a toothpaste containing potassium nitrate and sodium fluoride. Potassium nitrate is typically included in sensitivity relief toothpastes to help reduce tooth sensitivity, while sodium fluoride is commonly used in dentifrices to help prevent tooth decay and strengthen tooth enamel. This product is an unapproved drug and has not received FDA approval.
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Supplement & herbal interactions
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💊 What it looks like
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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 K679OBS311
Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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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 V8A1AW0880
Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
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UNII JP0CK963E0
A synthetic polymer made from polyethylene glycol and polypropylene glycol chains. It acts as a solubilizer and emulsifier to help dissolve and blend oil and water components in medicines.
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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 ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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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.
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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.
13 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 | 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/100gthis 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/g 59883-0031-04 | DENT-MAT | 1 tube | — | — | 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?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00404-0174-04 You're viewing this | 1 TUBE in 1 CARTON (0404-0174-04) / 113.4 g in 1 TUBE | 2025-01-30 | 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 | ✓ Available |
| 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
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Acclean Prescription Strength Anti-Cavity Toothpaste for Sensitivity Relief 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 12 or older, apply a thin ribbon or pea-sized amount of Acclean Prescription Strength Anti-Cavity Toothpaste for Sensitivity Relief 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 12 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 Acclean Prescription Strength Anti-Cavity Toothpaste for Sensitivity Relief: Green toothpaste containing 1.1% Sodium Fluoride, 5% Potassium Nitrate (Mint). ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Do not use in children under 12 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 12 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 Acclean Prescription Strength Anti-Cavity Toothpaste for Sensitivity Relief 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.
🤰 Pregnancy ▾
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.
🧒 Pediatric Use ▾
8.4Pediatric Use The use of Acclean Prescription Strength Anti-Cavity Toothpaste for Sensitivity Relief 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.
🧓 Geriatric Use ▾
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 Acclean Prescription Strength Anti-Cavity Toothpaste for Sensitivity Relief 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. (113.4g) net wt. tube Acclean Prescription Strength Anti-Cavity Toothpaste for Sensitivity Relief NDC 0404 0174 04 Store at controlled room temperature 15°-30° C (59°-86° F) Rx Only Distributed by: Henry Schein Inc. 135 Duryea Road Melville, NY 11747 USA 753212700 R:0 01/24SN
📋 Description ▾
11 DESCRIPTION Acclean Prescription Strength Anti-Cavity Toothpaste for Sensitivity Relief is a self-applied topical fluoride dentifrice containing 1.1% (w/w) sodium fluoride for the prevention and control of dental caries, and 5% (w/w) P otassium Nitrate for relief of tooth sensitivity. Sensitivity Relief: 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, PEG/PPG-116/66 Copolymer, Potassium Nitrate, Silica, Sodium Lauryl Sulfate, Sodium Saccharin, Sorbitol, Water, Xylitol.