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Gyntima Probiotica Forte Sage, Tea Tree Oil, Folic Acid, Lactic Acid 3 [hp_X]/1; 2 [hp_X]/1; 4 [hp_X]/1; 4 [hp_X]/1 Suppository, 4 suppositories

by Fytofontana LLC · 2 BLISTER PACK in 1 BOX (85401-021-24) / 2 SUPPOSITORY in 1 BLISTER PACK
NDC 85401-0021-24
🏷️ FDA NDC (as labeled) 85401-021-24 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 85401-021-24
Product NDC 85401-021
11-digit billing NDC 85401002124
UNII 065C5D077J, 3B8D35Y7S4, 935E97BOY8, VIF565UC2G
SPL Set ID 3c318c24-cc68-5589-e063-6394a90a8d80
Established class (EPC) Non-Standardized Plant Allergenic Extract; Non-Standardized Food Allergenic Extract
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens; Dietary Proteins; Plant Proteins
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-24
Route VAGINAL
Dosage form SUPPOSITORY
Substance SAGE; LACTIC ACID, DL-; FOLIC ACID; TEA TREE OIL
Why two NDCs? The FDA registers this code as 85401-021-24 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 85401-0021-24. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerFytofontana LLC
Labeler code85401
First marketedAug 2025
Product typeHuman Otc Drug
Portfolio3 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

Gyntima Probiotica Forte is a vaginal suppository containing folic acid, lactic acid, sage, and tea tree oil. This is a homeopathic product marketed based on homeopathic tradition and has not been evaluated by the FDA for effectiveness. In homeopathic practice, these ingredients are traditionally used for vaginal health and comfort, though homeopathic products are diluted according to homeopathic methods rather than containing standard drug amounts.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M93H91U80R
    Hydrolyzed casein is a protein derived from milk that has been broken down into smaller fragments. It functions as a binding agent and nutrient source in formulations, helping hold ingredients together and improve texture.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII U076Q6Q621
    Polyethylene glycol 1000 is a synthetic compound made from ethylene oxide. It serves as a solvent, lubricant, and humectant in medicines, helping dissolve active ingredients and improve how the product flows and feels.
  • UNII 1212Z7S33A
    PEG-32 is a synthetic polymer derived from ethylene oxide. It acts as a humectant and solvent in medications, helping to dissolve or suspend active ingredients and maintain moisture in solid dosage forms.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.

7 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesPEG 32, Lactosum, Polysorbatum 20, PEG 20, Natrii chloridum, Proteose pepton, Benzalkonii chloridum

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gyntima Probiotica Forte 3 [hp_X]/1; 2 [hp_X]/1; 4 [hp_X]/1; 4 [hp_X]this 85401-0021-24 Fytofontana 4 suppositories — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
On the market since
Aug 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85401-0021-24 You're viewing this 2 BLISTER PACK in 1 BOX (85401-021-24) / 2 SUPPOSITORY in 1 BLISTER PACK 2025-08-24 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Gyntima Probiotica Forte Sage, Tea Tree Oil, Folic Acid, Lactic Acid 3 [hp_X]/1; 2 [hp_X]/1; 4 [hp_X]/1; 4 [hp_X]/1 SUPPOSITORY is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Homeopathic". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 85401-021-24, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 85401-0021-24, written without dashes as 85401002124. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 85401-0021-24, the first segment (85401) is the labeler code FDA assigned to Fytofontana LLC; the middle segment (0021) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (24) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Fytofontana LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fytofontana LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 42 words ▾

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.

⏱️ Dosage and Administration 15 words ▾

Treatment: 1 suppository daily for 10 consecutive days Prevention: 1–2 suppositories per week, long-term maintenance

⚠️ Warnings 161 words ▾

Warnings: Do not use during menstruation. Do not use during pregnancy. The vaginal suppository is intended for vaginal use only.

Do not use if the packaging appears damaged. Do not use after the expiration date indicated on the package. Keep out of the reach of small children.

Precautions: Consult your gynecologist when using vaginal preparations along with vaginal contraceptives. If problems still persist after several days of use, consult your gynecologist. After gynecological procedures, use only with a physician’s approval.

Any possible discoloration is due to natural plant substances in the product and is not a sign that the preparation is defective. Regulatory Compliance: The active ingredients in this product are prepared in accordance with the Homeopathic Pharmacopoeia of the United States (HPUS). These uses are based on traditional homeopathic practice.

They have not been reviewed by the Food and Drug Administration. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 22 words ▾

Store in a cool, dry place away from heat sources and direct sunlight. Shelf life: 36 months from the date of manufacture.

🧪 Active Ingredient 70 words ▾

Acidum folicum 4X HPUS – Contributes to the regeneration and repair of vaginal tissues. Acidum lacticum 2X HPUS – Helps regulate vaginal pH and supports microbiome balance. Extractum Salviae officinalis 3X HPUS – Helps reduce irritation and supports hydration.

Oleum Melaleucae alternifolia (Tea Tree Oil) 4X HPUS – Traditionally used in homeopathy to support the body’s natural defenses against external imbalances, helping to protect and maintain a healthy vaginal microbiome.

🧪 Inactive Ingredients 13 words ▾

PEG 32, Lactosum, Polysorbatum 20, PEG 20, Natrii chloridum, Proteose pepton, Benzalkonii chloridum

🎯 Purpose 89 words ▾

Supports Vaginal Health Helps maintain the natural balance of the vaginal microbiome Supports hydration and elasticity of vaginal tissues Helps relieve discomfort, irritation, and pH imbalance while providing natural antimicrobial support to help maintain a healthy vaginal environment and support the body's natural defense against vaginal infections. 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85401-0020-23 · Fytofontana 85401-0022-26 · Fytofontana →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.