<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85401-021-24
</NDCCode>
<PackageDescription>
2 BLISTER PACK in 1 BOX (85401-021-24) / 2 SUPPOSITORY in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
85401-0021-24
</NDC11Code>
<ProductNDC>
85401-021
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Gyntima Probiotica Forte
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sage, Tea Tree Oil, Folic Acid, Lactic Acid
</NonProprietaryName>
<DosageFormName>
SUPPOSITORY
</DosageFormName>
<RouteName>
VAGINAL
</RouteName>
<StartMarketingDate>
20250824
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED HOMEOPATHIC
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Fytofontana LLC
</LabelerName>
<SubstanceName>
FOLIC ACID; LACTIC ACID, DL-; SAGE; TEA TREE OIL
</SubstanceName>
<StrengthNumber>
4; 2; 3; 4
</StrengthNumber>
<StrengthUnit>
[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
</StrengthUnit>
<Pharm_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]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-08-25
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250824
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>