What is NDC 85401-022?

85401-022 is the product NDC for Gyntima Menopausa, Lactic acid, Dl- 2 [hp_X]/1 + 2 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 Menopausa (Sage, Lactic Acid, Folic Acid).

What is the active ingredient?

Lactic acid, Dl-, Sage, Folic acid.

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 Menopausa?

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 Menopausa NDC 85401-022 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)85401-022Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85401-0022Add 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
85401-022-26	8540100222685401002226	2 BLISTER PACK in 1 BOX (85401-022-26) / 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 Menopausa
Generic name (nonproprietary): sage, lactic acid, folic acid
Active ingredients: Lactic acid, Dl- — 2 [hp_X]/1Sage — 3 [hp_X]/1Folic acid — 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 85401-022_3c57cd26-bdd9-a26f-e063-6294a90a2c45SPL ID 3c57cd26-bdd9-a26f-e063-6294a90a2c45SPL set ID 3c57cd26-bdd8-a26f-e063-6294a90a2c45UNII 3B8D35Y7S4, 065C5D077J, 935E97BOY8
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

N485401002226 followed by a unit qualifier and the quantity

Package 85401-0022-26. 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 14, 2025.

Indications (excerpt from the label)

Helps restore and maintain natural vaginal moisture levels, supporting comfort during menopause. Supports natural hydration and helps maintain the elasticity of vaginal tissues. Assists in relieving vaginal dryness, discomfort, itching, and sensitivity caused by hormonal changes. Designed to support the natural balance of the vaginal microbiome and mucosa.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85401-022

What is NDC 85401-022?: 85401-022 is the product NDC for Gyntima Menopausa, Lactic acid, Dl- 2 [hp_X]/1 + 2 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 Menopausa (Sage, Lactic Acid, Folic Acid).
What is the active ingredient?: Lactic acid, Dl-, Sage, Folic acid.
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 Menopausa?: 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.

Gyntima Menopausa (Sage, lactic acid, folic acid) NDC 85401-022