Prescription drug · UNAPPROVED DRUG OTHER
Denta 5000 Plus Sensitive NDC 16571-823
sodium fluoride and potassium nitrate · Sodium fluoride 5.8 mg/mL; Potassium nitrate 57.5 mg/mL · Gel, Dentifrice · Dental · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-823-10 | 16571082310 | 100 mL in 1 TUBE (16571-823-10)Marketed from Feb 14, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Denta 5000 Plus Sensitive
- Generic name (nonproprietary)
- sodium fluoride and potassium nitrate
- Active ingredients
- Sodium fluoride — 5.8 mg/mLPotassium nitrate — 57.5 mg/mL
- Dosage form
- Gel, Dentifrice
- Route
- Dental
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 16571-823_3d38b4ec-9283-448f-8fc5-d51cca9de7a6SPL ID 3d38b4ec-9283-448f-8fc5-d51cca9de7a6SPL set ID 585fb1f5-8c08-43bd-8be4-64adc065d9a2UNII 8ZYQ1474W7, RU45X2JN0Z
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N416571082310followed by a unit qualifier and the quantityPackage 16571-0823-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE: A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult patients and children 12 years of age and older. 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 Denta 5000 Plus Sensitive 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze tube is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless ot…
Excerpt only. Read the full label for complete information.