NDC codes

FDA NDC Directory
Product NDC (as listed)54473-302Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54473-0302Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
54473-302-045447303020454473030204108 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

N454473030204 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under part356
ProductStrengthForm · routeLabelerProduct NDC
Dental ReliefbenzocaineBenzocaine 200 mg/gLiquidTopicalCintas First Aid & Safety68421-8100
ENT Essentials Ear Wax Remvoercarbamide peroxideCarbamide peroxide .065 g/gLiquidAuricular (Otic)Wisconsin Pharmacal Company68093-4503

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in