What is NDC 58264-0061?

58264-0061 is the product NDC for D-61, Tobacco leaf 12 [hp_X]/mL + 8 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-61 (Tobacco leaf, salix nigra bark, camphor (natural), turpentine oil, berberis vulgaris root bark, solanum dulcamara whole, strychnos nux-vomica seed, rhododendron aureum leaf, and toxicodendron pubescens leaf).

What is the active ingredient?

Tobacco leaf, Salix nigra bark, Camphor (Natural), Turpentine oil, Berberis vulgaris root bark, Solanum dulcamara whole, Strychnos nux-vomica seed, Rhododendron aureum leaf, Toxicodendron pubescens leaf.

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-61?

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-61 NDC 58264-0061 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58264-0061Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58264-0061Add 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
58264-0061-1	5826400610158264006101	29.57 mL in 1 BOTTLE, GLASS (58264-0061-1)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-61
Generic name (nonproprietary): tobacco leaf, salix nigra bark, camphor (natural), turpentine oil, berberis vulgaris root bark, solanum dulcamara whole, strychnos nux-vomica seed, rhododendron aureum leaf, and toxicodendron pubescens leaf
Active ingredients: Tobacco leaf — 12 [hp_X]/mLSalix nigra bark — 3 [hp_X]/mLCamphor (Natural) — 6 [hp_X]/mLTurpentine oil — 6 [hp_X]/mLBerberis vulgaris root bark — 2 [hp_X]/mLSolanum dulcamara whole — 2 [hp_X]/mLStrychnos nux-vomica seed — 2 [hp_X]/mLRhododendron aureum leaf — 3 [hp_X]/mLToxicodendron pubescens leaf — 3 [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)Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Plant Proteins (Chemical structure)Plant Proteins (Chemical structure)Seed Storage Proteins (Chemical structure)
Identifiers: Product ID 58264-0061_2b9eda10-4e91-e31e-e063-6394a90a53c6SPL ID 2b9eda10-4e91-e31e-e063-6394a90a53c6SPL set ID 5582d3d0-cf33-45d8-b3fb-5bf85e15bdfaUNII 6YR2608RSU, QU52J3A5B3, N20HL7Q941, C5H0QJ6V7F, 1TH8Q20J0U, G72JA9DHK5, 269XH13919, IV92NQJ73U, 6IO182RP7A
Pharmacologic class: Non-Standardized Plant Allergenic Extract

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

N458264006101 followed by a unit qualifier and the quantity

Package 58264-0061-01. 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 Pain down back of legs, low back pain.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58264-0061

What is NDC 58264-0061?: 58264-0061 is the product NDC for D-61, Tobacco leaf 12 [hp_X]/mL + 8 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-61 (Tobacco leaf, salix nigra bark, camphor (natural), turpentine oil, berberis vulgaris root bark, solanum dulcamara whole, strychnos nux-vomica seed, rhododendron aureum leaf, and toxicodendron pubescens leaf).
What is the active ingredient?: Tobacco leaf, Salix nigra bark, Camphor (Natural), Turpentine oil, Berberis vulgaris root bark, Solanum dulcamara whole, Strychnos nux-vomica seed, Rhododendron aureum leaf, Toxicodendron pubescens leaf.
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-61?: 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.