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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOLIC ACID4 [hp_X]/1
LACTIC ACID, DL-2 [hp_X]/1
SAGE3 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii935E97BOY8, 3B8D35Y7S4, 065C5D077J

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
85401-020-23GYNTIMA Probiotica2 in 1 BOXSUPPOSITORY21
85401-020-23GYNTIMA Probiotica2 in 1 BLISTER PACKSUPPOSITORY21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85401-020-23854010020232 BLISTER PACK in 1 BOX (85401-020-23) / 2 SUPPOSITORY in 1 BLISTER PACK2 blister pack2025-08-24NoNoCurrent