gyntima probiotica

Generic: lactic acid, folic acid, sage

Labeler: fytofontana llc
NDC Directory HUMAN OTC DRUG UNAPPROVED HOMEOPATHIC Inactive Finished

Drug Facts

Product Profile

Brand Name gyntima probiotica
Generic Name lactic acid, folic acid, sage
Labeler fytofontana llc
Dosage Form SUPPOSITORY
Routes
VAGINAL
Active Ingredients

folic acid 4 [hp_X]/1, lactic acid, dl- 2 [hp_X]/1, sage 3 [hp_X]/1

Manufacturer
Fytofontana LLC

Identifiers & Regulatory

Product NDC 85401-020
Product ID 85401-020_31b83e91-bdd2-bdd1-e063-6394a90a16d7
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED HOMEOPATHIC
Listing Expiration 2026-12-31
Marketing Start 2025-08-24

Pharmacologic Class

Established (EPC)
non-standardized plant allergenic extract [epc] non-standardized food allergenic extract [epc]
Chemical Structure
allergens [cs] dietary proteins [cs] plant proteins [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85401020
Hyphenated Format 85401-020

Supplemental Identifiers

UNII
935E97BOY8 3B8D35Y7S4 065C5D077J
NUI
N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name gyntima probiotica (source: ndc)
Generic Name lactic acid, folic acid, sage (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 4 [hp_X]/1
  • 2 [hp_X]/1
  • 3 [hp_X]/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 BOX (85401-020-23) / 2 SUPPOSITORY in 1 BLISTER PACK
source: ndc

Packages (1)

85401-020-23 2 BLISTER PACK in 1 BOX (85401-020-23) / 2 SUPPOSITORY in 1 BLISTER PACK

Ingredients (3)

folic acid (4 [hp_X]/1) lactic acid, dl- (2 [hp_X]/1) sage (3 [hp_X]/1)

Linked Drug Pages (1)

GYNTIMA Probiotica ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "31b83e91-bdd2-bdd1-e063-6394a90a16d7", "openfda": {"nui": ["N0000185375", "N0000185371", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962"], "unii": ["935E97BOY8", "3B8D35Y7S4", "065C5D077J"], "spl_set_id": ["31b83e91-bdd1-bdd1-e063-6394a90a16d7"], "pharm_class_cs": ["Allergens [CS]", "Dietary Proteins [CS]", "Plant Proteins [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Non-Standardized Plant Allergenic Extract [EPC]", "Non-Standardized Food Allergenic Extract [EPC]"], "manufacturer_name": ["Fytofontana LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 BOX (85401-020-23)  / 2 SUPPOSITORY in 1 BLISTER PACK", "package_ndc": "85401-020-23", "marketing_start_date": "20250824"}], "brand_name": "GYNTIMA Probiotica", "product_id": "85401-020_31b83e91-bdd2-bdd1-e063-6394a90a16d7", "dosage_form": "SUPPOSITORY", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Dietary Proteins [CS]", "Increased Histamine Release [PE]", "Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]", "Plant Proteins [CS]"], "product_ndc": "85401-020", "generic_name": "Lactic Acid, Folic Acid, Sage", "labeler_name": "Fytofontana LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "GYNTIMA Probiotica", "active_ingredients": [{"name": "FOLIC ACID", "strength": "4 [hp_X]/1"}, {"name": "LACTIC ACID, DL-", "strength": "2 [hp_X]/1"}, {"name": "SAGE", "strength": "3 [hp_X]/1"}], "marketing_category": "UNAPPROVED HOMEOPATHIC", "marketing_start_date": "20250824", "listing_expiration_date": "20261231"}