Prescription drug · UNAPPROVED DRUG OTHER
Sodium Fluoride and Potassium Nitrate NDC 69367-318
Sodium fluoride 5.8 mg/mL; Potassium nitrate 57.5 mg/mL · Gel · Dental · Westminster Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69367-318-01 | 6936703180169367031801 | 1 TUBE in 1 CARTON (69367-318-01) / 100 mL in 1 TUBEMarketed from Jun 15, 2022 |
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)
- Sodium Fluoride and Potassium Nitrate
- Generic name (nonproprietary)
- sodium fluoride and potassium nitrate
- Active ingredients
- Sodium fluoride — 5.8 mg/mLPotassium nitrate — 57.5 mg/mL
- Dosage form
- Gel
- Route
- Dental
- Labeler
- Westminster Pharmaceuticals, LLCNDC labeler code 69367
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 69367-318_0c9c8462-f962-4615-8649-dea8e1ecb498SPL ID 0c9c8462-f962-4615-8649-dea8e1ecb498SPL set ID 7a051d80-879d-4995-96ef-77b60dad26b7RxCUI 637365UNII 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
N469367031801followed by a unit qualifier and the quantityPackage 69367-0318-01. 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, acid, 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 Sodium Fluoride 1.1% and Potassium Nitrate 5% Sensitive 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 otherwise instructed by your de…
Excerpt only. Read the full label for complete information.
About NDC 69367-318
- What is NDC 69367-318?
- 69367-318 is the product NDC for Sodium Fluoride and Potassium Nitrate, Sodium fluoride 5.8 mg/mL; Potassium nitrate 57.5 mg/mL gel, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium Fluoride and Potassium Nitrate.
- What is the active ingredient?
- Sodium fluoride, Potassium nitrate.
- Who is the labeler?
- Westminster Pharmaceuticals, LLC, NDC labeler code 69367. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sodium Fluoride and Potassium Nitrate?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.