NDC codes

FDA NDC Directory
Product NDC (as listed)80004-400Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80004-0400Add 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
80004-400-4080004040040800040400401 TUBE in 1 CARTON (80004-400-40) / 85 g in 1 TUBEMarketed from Mar 1, 2024

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)
Arnica Gel 15 Arnica Montana 1X HPUSSuffix: Arnica Montana 1X HPUS
Generic name (nonproprietary)
arnica gel
Active ingredients
Hypericum perforatum — 1 [hp_X]/gSymphytum officinale whole — 6 [hp_X]/gArnica montana whole — 30 [hp_C]/gRhus typhina whole — 30 [hp_X]/gHamamelis virginiana bark — 1 [hp_X]/gCalendula officinalis flowering top — 1 [hp_X]/gArnica montana flower — 1 [hp_X]/gLedum palustre whole — 12 [hp_X]/gAchillea millefolium flower — 12 [hp_X]/gBelladonna leaf — 30 [hp_X]/gBellis perennis flower — 12 [hp_X]/gRuta graveolens whole — 30 [hp_X]/g
Dosage form
Gel
Route
Topical
Labeler
VITAMEDICA, INC.NDC labeler code 80004
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Identifiers
Product ID 80004-400_4e5703a4-8d42-cd94-e063-6294a90a5a89SPL ID 4e5703a4-8d42-cd94-e063-6294a90a5a89SPL set ID 4e56ff37-e260-be18-e063-6294a90aacedUNII XK4IUX8MNB, H8FJJ6KX5Y, O80TY208ZW, Y465D8AABT, IH3063S9MY, 18E7415PXQ, OZ0E5Y15PZ, 1N8KG72C5M, YQR8R0SQEA, 6GZW20TIOI, 26I94X9A1K, 181JI0338P

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

N480004040040 followed by a unit qualifier and the quantity

Package 80004-0400-40. 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: *Temporarily relieves these symptoms: • Bruising • Swelling • Pain • Stiff • Muscle Soreness *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80004-400

What is NDC 80004-400?
80004-400 is the product NDC for Arnica Gel 15 Arnica Montana 1X HPUS, Hypericum perforatum 1 [hp_X]/g + 11 more ingredients gel, listed with the FDA by VITAMEDICA, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Arnica Gel 15 Arnica Montana 1X HPUS (Arnica Gel).
What is the active ingredient?
Hypericum perforatum, Symphytum officinale whole, Arnica montana whole, Rhus typhina whole, Hamamelis virginiana bark, Calendula officinalis flowering top, Arnica montana flower, Ledum palustre whole, Achillea millefolium flower, Belladonna leaf, Bellis perennis flower, Ruta graveolens whole.
Who is the labeler?
VITAMEDICA, INC., NDC labeler code 80004. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Arnica Gel 15 Arnica Montana 1X HPUS?
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.

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