What is NDC 58264-0016?

58264-0016 is the product NDC for D-16, Black cohosh 4 [hp_X]/mL + 4 more ingredients solution/ drops, 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-16 (Black cohosh, iris versicolor root, sanguinaria canadensis root, gelsemium sempervirens root, and spigelia anthelmia).

What is the active ingredient?

Black cohosh, Iris versicolor root, Sanguinaria canadensis root, Gelsemium sempervirens root, Spigelia anthelmia.

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-16?

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-16 NDC 58264-0016 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58264-0016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58264-0016Add 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
58264-0016-1	5826400160158264001601	29.57 mL in 1 BOTTLE, GLASS (58264-0016-1)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-16
Generic name (nonproprietary): black cohosh, iris versicolor root, sanguinaria canadensis root, gelsemium sempervirens root, and spigelia anthelmia
Active ingredients: Black cohosh — 4 [hp_X]/mLIris versicolor root — 2 [hp_X]/mLSanguinaria canadensis root — 2 [hp_X]/mLGelsemium sempervirens root — 3 [hp_X]/mLSpigelia anthelmia — 4 [hp_X]/mL
Dosage form: Solution/ drops
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 58264-0016_2b9ea65c-9dfc-ad89-e063-6394a90ab44cSPL ID 2b9ea65c-9dfc-ad89-e063-6394a90ab44cSPL set ID 4784ddc2-c308-4092-a01f-ea2b2954a888UNII K73E24S6X9, X43D4L3DQC, N9288CD508, 639KR60Q1Q, WYT05213GE

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

N458264001601 followed by a unit qualifier and the quantity

Package 58264-0016-01. 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 Migraine, nervous headaches.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58264-0016

What is NDC 58264-0016?: 58264-0016 is the product NDC for D-16, Black cohosh 4 [hp_X]/mL + 4 more ingredients solution/ drops, 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-16 (Black cohosh, iris versicolor root, sanguinaria canadensis root, gelsemium sempervirens root, and spigelia anthelmia).
What is the active ingredient?: Black cohosh, Iris versicolor root, Sanguinaria canadensis root, Gelsemium sempervirens root, Spigelia anthelmia.
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-16?: 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.