Topco Associates LLC Maximum Strength Fluoride .15 g/100g; 5 g/100g Paste, Dentifrice — NDC 36800-364-10 (Billing 36800-0364-10)
This is a package of Topco Associates LLC Maximum Strength Fluoride .15 g/100g; 5 g/100g Paste, Dentifrice from Topco Associates LLC, marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 36800-364-10 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 36800 labeler · 364 product · 10 package
- Package marketed since
- Jun 26, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 3680036410 4
- FDA record last changed
- Aug 27, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1038929
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
- Mostly it helps prevent cavities. Some toothpastes are also labeled for tooth sensitivity (H E B) or for bleeding gums and plaque linked to gingivitis (CVS Pharmacy). Check your pr...
- For the 365 Whole Foods Market and Equate rinses, use it twice a day after brushing, if you're 6 or older. Swish 10 mL (2 teaspoonfuls) for 1 minute, then spit it out. Don't eat or...
- Yes, with care. Children under 6 should be taught to spit and be supervised, and many toothpastes call for a pea-sized amount. Check the age directions on your product. Under 2 yea...
- If more than a normal brushing amount is swallowed, get medical help or call Poison Control right away. Don't wait for symptoms.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 36800-0364-10 You're viewing this Main listing | 1 TUBE in 1 CARTON / 113 g in 1 TUBE | 2025-06-26 | — | Active |
Therapeutic equivalents
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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?
- FDA Orange Book · refreshed Oct 3, 2026
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 5OCF3O11KX
A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
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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 Y6O7T4G8P9
Hydrated silica is a fine powder form of silicon dioxide with absorbed water. It works as an anti-caking agent and absorbent in medicines, helping powders stay free-flowing and preventing clumping.
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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 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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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 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
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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 TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
12 inactive ingredients listed in the exact product block matched to this NDC.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Topco Associates LLC labeler code 36800
- TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50 OCTISALATE, ZINC OXIDE 145 mg/mL; 50 mg/mL Lotion NDC 36800-347-11
- Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30 ZINC OXIDE 150 mg/g Spray NDC 36800-351-50
- Body Wash Salicylic Acid 20 mg/mL Gel NDC 36800-354-23
- Topcare Everyday Sport Continuous Broad Spectrum SPF 100 Avobenzone, Homosalate, Octisalate, Octocrylene 30 mg/g; 150 mg/g; 50 mg/g; 100 mg/g Spray NDC 36800-356-37
- Intensive Enamel Repair Whitening TP 5 g/100g; .15 g/100g Paste, Dentifrice NDC 36800-362-10
- topcare childrens allergy relief loratadine 5 mg Tablet, Chewable NDC 36800-363-39
- TopCare Allergy Relief diphenhydramine hydrochloride 25 mg Capsule, Liquid Filled NDC 36800-367-24
- TopCare All Day Pain Relief Naproxen Sodium 220 mg Tablet, Film Coated NDC 36800-368-62
- Topcare 8 Hour Pain Relief Acetaminophen 650 mg Tablet, Film Coated, Extended Release NDC 36800-369-78
- Advanced Ethyl Alcohol 70 mL/100mL Gel NDC 36800-370-16
- Salicylic acid Medicated Callus Removers Extra Thick 40 mg/41 Patch NDC 36800-373-04
- topcare nicotine polacrilex 2 mg Lozenge NDC 36800-375-05
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
Directions Adults and children 12 years of age and older: apply at least a 1-inch strip of product onto a soft bristle toothbrush brush teeth thoroughly for at least one minute twice a day (morning and evening), and not more than 3 tims a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimiza swallowing. Spit out after brushing. children under 12 years of age: Consult a dentist or doctor.
⏱️ Dosage and Administration ▾
adults and children 12 years of age and older: a pply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.
⚠️ Warnings ▾
When using this product, if irritation occurs discontinue use. Stop use and ask a dentist if the problem persists or worsen Sensitive teeth may indicate a resious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use Keep out of reach of children. If more than used for burshing is accidentally swallowed, get medical help or contact a Poison Center right away.
🧪 Active Ingredient ▾
Active ingredients / Purpose Potassium nitrate 5%....................................................Antihypersensitivity Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity
🧪 Inactive Ingredients ▾
Inactive ingredients water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, xanthan gum, flavor, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1
🎯 Purpose ▾
Uses builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact aids in the prevention of dental cavities
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a dentist if the problem persists or worsen Sensitive teeth may indicate a resious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If more than used for burshing is accidentally swallowed, get medical help or contact a Poison Center right away.
📄 Package Label / Principal Display Panel ▾
5280184 Topcare Sensitive Mint fresh 2821184R4-OL
About this NDC listing & data coverage
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. |