Home NDC 85401-020 GYNTIMA Probiotica
Product NDC 85401-020
11-digit product format 854010020
Labeler code 85401
Product ID 85401-020_31b83e91-bdd2-bdd1-e063-6394a90a16d7
Type HUMAN OTC DRUG
Nonproprietary name Lactic Acid, Folic Acid, Sage
Dosage form SUPPOSITORY
Route VAGINAL
Labeler Fytofontana LLC
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2025-08-24
Substance FOLIC ACID; LACTIC ACID, DL-; SAGE
Active strength 4; 2; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base GYNTIMA Probiotica
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LACTIC ACID, DL- 2 [hp_X]/1 SAGE 3 [hp_X]/1 FOLIC ACID 4 [hp_X]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3B8D35Y7S4 Internal UNII lookup 065C5D077J Internal UNII lookup 935E97BOY8 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85401-020-23 GYNTIMA Probiotica 2 in 1 BOX SUPPOSITORY 2 1 85401-020-23 GYNTIMA Probiotica 2 in 1 BLISTER PACK SUPPOSITORY 2 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85401-020-23 85401002023 2 BLISTER PACK in 1 BOX (85401-020-23) / 2 SUPPOSITORY in 1 BLISTER PACK 2 blister pack 2025-08-24 No No Current