Over-the-counter drug · OTC MONOGRAPH NOT FINAL
Sensitive Tooth Polish (Potassium nitrate and sodium fluoride) NDC 54473-302
Sodium fluoride .26244 g/108g; Potassium nitrate 5.4 g/108g · Paste, Dentifrice · Topical · Melaleuca, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54473-302-04 | 5447303020454473030204 | 108 g in 1 TUBE (54473-302-04)Marketed from Jan 1, 2018 |
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)
- Sensitive Tooth PolishSuffix: Tooth Polish
- Generic name (nonproprietary)
- potassium nitrate and sodium fluoride
- Active ingredients
- Sodium fluoride — .26244 g/108gPotassium nitrate — 5.4 g/108g
- Dosage form
- Paste, Dentifrice
- Route
- Topical
- Labeler
- Melaleuca, Inc.NDC labeler code 54473
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (not final)Application part356
- Marketing start
- Listing expires
- Identifiers
- Product ID 54473-302_68933f55-0cd9-0074-e053-2991aa0adfb7SPL ID 68933f55-0cd9-0074-e053-2991aa0adfb7SPL set ID 689349e4-3980-a0e4-e053-2991aa0a9ef5RxCUI 1038800UNII 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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N454473030204followed by a unit qualifier and the quantityPackage 54473-0302-04. 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)
Uses when used regularly, builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact aids in the prevention of cavities
Excerpt only. Read the full label for complete information.
About NDC 54473-302
- What is NDC 54473-302?
- 54473-302 is the product NDC for Sensitive Tooth Polish, Sodium fluoride .26244 g/108g; Potassium nitrate 5.4 g/108g paste, dentifrice, listed with the FDA by Melaleuca, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sensitive Tooth Polish (Potassium Nitrate and Sodium Fluoride).
- What is the active ingredient?
- Sodium fluoride, Potassium nitrate.
- Who is the labeler?
- Melaleuca, Inc., NDC labeler code 54473. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sensitive Tooth Polish?
- 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.
Other NDCs under part356
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dental Reliefbenzocaine | Benzocaine 200 mg/g | LiquidTopical | Cintas First Aid & Safety | 68421-8100 |
| ENT Essentials Ear Wax Remvoercarbamide peroxide | Carbamide peroxide .065 g/g | LiquidAuricular (Otic) | Wisconsin Pharmacal Company | 68093-4503 |