What is NDC 58264-0035?

58264-0035 is the product NDC for D-35, Aconitum napellus 6 [hp_X]/mL + 6 more ingredients solution, listed with the FDA by DNA Labs, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

D-35 (Aconitum napellus, Oyster shell calcium carbonate, crude, Matricaria chamomilla, Citrullus colocynthis fruit pulp, Strychnos ignatii seed, Delphinium staphisagria seed, and Bryonia alba Root).

What is the active ingredient?

Aconitum napellus, Oyster shell calcium carbonate, Crude, Matricaria chamomilla, Citrullus colocynthis fruit pulp, Strychnos ignatii seed, Delphinium staphisagria seed, Bryonia alba root.

DNA Labs, Inc., NDC labeler code 58264. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for D-35?

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.

D-35 NDC 58264-0035 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58264-0035Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58264-0035Add 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 NDC	11-digit (billing)	Package	Copy
58264-0035-1	5826400350158264003501	29.57 mL in 1 BOTTLE, GLASS (58264-0035-1)Marketed from Jan 1, 1990

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): D-35
Generic name (nonproprietary): aconitum napellus, oyster shell calcium carbonate, crude, matricaria chamomilla, citrullus colocynthis fruit pulp, strychnos ignatii seed, delphinium staphisagria seed, and bryonia alba root
Active ingredients: Aconitum napellus — 6 [hp_X]/mLOyster shell calcium carbonate, Crude — 30 [hp_X]/mLMatricaria chamomilla — 4 [hp_X]/mLCitrullus colocynthis fruit pulp — 12 [hp_X]/mLStrychnos ignatii seed — 30 [hp_X]/mLDelphinium staphisagria seed — 8 [hp_X]/mLBryonia alba root — 30 [hp_X]/mL
Dosage form: Solution
Route: Sublingual
Labeler: DNA Labs, Inc.NDC labeler code 58264
Product type: Over-the-counter drug
Marketing category: Unapproved homeopathic
Marketing start: Jan 1, 1990
Listing expires: Dec 31, 2026
Identifiers: Product ID 58264-0035_2b9ecbda-7105-d64a-e063-6294a90aac9eSPL ID 2b9ecbda-7105-d64a-e063-6294a90aac9eSPL set ID 275cc8ec-30ed-4dd9-815c-d082ee5b3a99UNII U0NQ8555JD, 2E32821G6I, G0R4UBI2ZZ, 23H32AOH17, 1NM3M2487K, 00543AP1JV, T7J046YI2B

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. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N458264003501 followed by a unit qualifier and the quantity

Package 58264-0035-01. 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 Jan 13, 2025.

Indications (excerpt from the label)

INDICATIONS Teething aches and cramps, toothaches.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58264-0035

What is NDC 58264-0035?: 58264-0035 is the product NDC for D-35, Aconitum napellus 6 [hp_X]/mL + 6 more ingredients solution, listed with the FDA by DNA Labs, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: D-35 (Aconitum napellus, Oyster shell calcium carbonate, crude, Matricaria chamomilla, Citrullus colocynthis fruit pulp, Strychnos ignatii seed, Delphinium staphisagria seed, and Bryonia alba Root).
What is the active ingredient?: Aconitum napellus, Oyster shell calcium carbonate, Crude, Matricaria chamomilla, Citrullus colocynthis fruit pulp, Strychnos ignatii seed, Delphinium staphisagria seed, Bryonia alba root.
Who is the labeler?: DNA Labs, Inc., NDC labeler code 58264. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for D-35?: 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.