FDA.reportPublic FDA data

Gyntima Probiotica Forte

Product NDC
85401-021
11-digit product format
854010021
Labeler code
85401
Product ID
85401-021_3c318c24-cc69-5589-e063-6394a90a8d80
Type
HUMAN OTC DRUG
Nonproprietary name
Sage, Tea Tree Oil, Folic Acid, Lactic Acid
Dosage form
SUPPOSITORY
Route
VAGINAL
Labeler
Fytofontana LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2025-08-24
Substance
FOLIC ACID; LACTIC ACID, DL-; SAGE; TEA TREE OIL
Active strength
4; 2; 3; 4 [hp_X]/1; [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

Additional Listing Data#

Finished product
Yes
Brand name base
Gyntima Probiotica Forte
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SAGE4 [hp_X]/1
LACTIC ACID, DL-2 [hp_X]/1
FOLIC ACID3 [hp_X]/1
TEA TREE OIL4 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
065C5D077JInternal UNII lookup
3B8D35Y7S4Internal UNII lookup
935E97BOY8Internal UNII lookup
VIF565UC2GInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c318c24-cc68-5589-e063-6394a90a8d80Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85401-021-24Gyntima Probiotica Forte2 in 1 BOXSUPPOSITORY21
85401-021-24Gyntima Probiotica Forte2 in 1 BLISTER PACKSUPPOSITORY21

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gyntima Probiotica ForteSAGE, TEA TREE OIL, FOLIC ACID, LACTIC ACIDFytofontana LLC3c318c24-cc68-5589-e063-6394a90a8d802025-08-12WarningsExact identifier
ndc (product): 85401-021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85401-021-24854010021242 BLISTER PACK in 1 BOX (85401-021-24) / 2 SUPPOSITORY in 1 BLISTER PACK2 blister pack2025-08-24NoNoCurrent