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
54473-302-0454473030204108 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
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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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

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