What is NDC 58264-0115?

58264-0115 is the product NDC for D-109, Atropa belladonna 6 [hp_X]/mL + 9 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-109 (ATROPA BELLADONNA, VIROLA SEBIFERA RESIN, SILICON DIOXIDE, CALCIUM FLUORIDE, SODIUM BORATE, GOLD, BAPTISIA TINCTORIA ROOT, MERCURIC CYANIDE, CALOMEL, and CORNUS RUGOSA WHOLE).

What is the active ingredient?

Atropa belladonna, Virola sebifera resin, Silicon dioxide, Calcium fluoride, Sodium borate, Gold, Baptisia tinctoria root, Mercuric cyanide, Calomel, Cornus rugosa whole.

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-109?

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-109 NDC 58264-0115 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58264-0115Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58264-0115Add 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
58264-0115-1	5826401150158264011501	29.57 mL in 1 BOTTLE, GLASS (58264-0115-1)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-109
Generic name (nonproprietary): atropa belladonna, virola sebifera resin, silicon dioxide, calcium fluoride, sodium borate, gold, baptisia tinctoria root, mercuric cyanide, calomel, and cornus rugosa whole
Active ingredients: Atropa belladonna — 6 [hp_X]/mLVirola sebifera resin — 4 [hp_X]/mLSilicon dioxide — 8 [hp_X]/mLCalcium fluoride — 8 [hp_X]/mLSodium borate — 4 [hp_X]/mLGold — 8 [hp_X]/mLBaptisia tinctoria root — 4 [hp_X]/mLMercuric cyanide — 8 [hp_X]/mLCalomel — 8 [hp_X]/mLCornus rugosa whole — 9 [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
Other FDA classes: Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)
Identifiers: Product ID 58264-0115_2b9ef9ce-f829-5195-e063-6294a90a28c2SPL ID 2b9ef9ce-f829-5195-e063-6294a90a28c2SPL set ID 7758341d-e0be-487a-ba47-8847551231e1UNII WQZ3G9PF0H, GHJ5XX5SGS, ETJ7Z6XBU4, O3B55K4YKI, 91MBZ8H3QO, 79Y1949PYO, 5EF0HWI5WU, RWG7BD1032, J2D46N657D, 7N444M3926
Pharmacologic class: Standardized Chemical Allergen

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

N458264011501 followed by a unit qualifier and the quantity

Package 58264-0115-01. 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 Abscess at root of teeth.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58264-0115

What is NDC 58264-0115?: 58264-0115 is the product NDC for D-109, Atropa belladonna 6 [hp_X]/mL + 9 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-109 (ATROPA BELLADONNA, VIROLA SEBIFERA RESIN, SILICON DIOXIDE, CALCIUM FLUORIDE, SODIUM BORATE, GOLD, BAPTISIA TINCTORIA ROOT, MERCURIC CYANIDE, CALOMEL, and CORNUS RUGOSA WHOLE).
What is the active ingredient?: Atropa belladonna, Virola sebifera resin, Silicon dioxide, Calcium fluoride, Sodium borate, Gold, Baptisia tinctoria root, Mercuric cyanide, Calomel, Cornus rugosa whole.
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-109?: 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.