NDC codes

FDA NDC Directory
Product NDC (as listed)54473-334Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54473-0334Add 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
54473-334-03544730334035447303340385 g in 1 TUBE (54473-334-03)Marketed from Oct 1, 2021

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)
Ultra Pain-A-Trate Pain-Relieving CreamSuffix: Pain-Relieving Cream
Generic name (nonproprietary)
camphor and menthol and methyl salicylate
Active ingredients
Camphor (Synthetic) — 3.4 g/85gMenthol — 8.5 g/85gMethyl salicylate — 25.5 g/85g
Dosage form
Cream
Route
Topical
Labeler
Melaleuca, Inc.NDC labeler code 54473
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication 505G(a)(3)
Marketing start
Listing expires
Identifiers
Product ID 54473-334_4746dd93-6d18-ced6-e063-6394a90aea2cSPL ID 4746dd93-6d18-ced6-e063-6394a90aea2cSPL set ID cf48b8ca-651d-20d4-e053-2a95a90a4310RxCUI 283083UNII 5TJD82A1ET, L7T10EIP3A, LAV5U5022Y

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

N454473033403 followed by a unit qualifier and the quantity

Package 54473-0334-03. 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 For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Provides penetrating relief.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54473-334

What is NDC 54473-334?
54473-334 is the product NDC for Ultra Pain-A-Trate Pain-Relieving Cream, Camphor (Synthetic) 3.4 g/85g + 2 more ingredients cream, 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?
Ultra Pain-A-Trate Pain-Relieving Cream (Camphor and Menthol and Methyl Salicylate).
What is the active ingredient?
Camphor (Synthetic), Menthol, Methyl salicylate.
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 Ultra Pain-A-Trate Pain-Relieving Cream?
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 505G(a)(3)

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

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