What is NDC 85401-021?

85401-021 is the product NDC for Gyntima Probiotica Forte, Sage 3 [hp_X]/1 + 3 more ingredients suppository, listed with the FDA by Fytofontana LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Gyntima Probiotica Forte (Sage, Tea Tree Oil, Folic Acid, Lactic Acid).

What is the active ingredient?

Sage, Lactic acid, Dl-, Folic acid, Tea tree oil.

Fytofontana LLC, NDC labeler code 85401. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Gyntima Probiotica Forte?

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.

Gyntima Probiotica Forte NDC 85401-021

NDC codes

FDA NDC Directory

Product NDC (as listed)85401-021Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85401-0021Add 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
85401-021-24	8540100212485401002124	2 BLISTER PACK in 1 BOX (85401-021-24) / 2 SUPPOSITORY in 1 BLISTER PACKMarketed from Aug 24, 2025

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): Gyntima Probiotica Forte
Generic name (nonproprietary): sage, tea tree oil, folic acid, lactic acid
Active ingredients: Sage — 3 [hp_X]/1Lactic acid, Dl- — 2 [hp_X]/1Folic acid — 4 [hp_X]/1Tea tree oil — 4 [hp_X]/1
Dosage form: Suppository
Route: Vaginal
Labeler: Fytofontana LLCNDC labeler code 85401
Product type: Over-the-counter drug
Marketing category: Unapproved homeopathic
Marketing start: Aug 24, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Dietary Proteins (Chemical structure)Increased Histamine Release (Physiologic effect)Plant Proteins (Chemical structure)
Identifiers: Product ID 85401-021_3c318c24-cc69-5589-e063-6394a90a8d80SPL ID 3c318c24-cc69-5589-e063-6394a90a8d80SPL set ID 3c318c24-cc68-5589-e063-6394a90a8d80UNII 065C5D077J, 3B8D35Y7S4, 935E97BOY8, VIF565UC2G
Pharmacologic class: Non-Standardized Food Allergenic Extract; 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N485401002124 followed by a unit qualifier and the quantity

Package 85401-0021-24. 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 Aug 12, 2025.

Indications (excerpt from the label)

Lowers vaginal pH to create an unfavorable environment for harmful pathogens, while creating the ideal conditions for the body’s own beneficial bacteria, particularly Lactobacillus species, to thrive. Tea tree oil and sage extract provide additional antimicrobial effects, supporting balance and local comfort.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85401-021

What is NDC 85401-021?: 85401-021 is the product NDC for Gyntima Probiotica Forte, Sage 3 [hp_X]/1 + 3 more ingredients suppository, listed with the FDA by Fytofontana LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Gyntima Probiotica Forte (Sage, Tea Tree Oil, Folic Acid, Lactic Acid).
What is the active ingredient?: Sage, Lactic acid, Dl-, Folic acid, Tea tree oil.
Who is the labeler?: Fytofontana LLC, NDC labeler code 85401. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gyntima Probiotica Forte?: 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.