FDA.reportPublic FDA data

NDC 13533-200 - FESILTY

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
13533-200
Package NDCs from labels
13533-200-50, 13533-200-10, 13533-200-05, 13533-200-20
Manufacturer
Grifols USA LLC | Biotest AG | Grifols Therapeutics LLC | Laboratorios Grifols, S.A. | Instituto Grifols, S.A. | Prothya Biosolutions Belgium | TechPharm GmbH | GBA Pharma GmbH
Effective date
2026-08-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FESILTYGrifols USA LLC | Biotest AG | Grifols Therapeutics LLC | Laboratorios Grifols, S.A. | Instituto Grifols, S.A. | Prothya Biosolutions Belgium | TechPharm GmbH | GBA Pharma GmbH2026-08-20PLASMA DERIVATIVE
Alanine - GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SAGRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA2025-08-21PLASMA DERIVATIVE
Koate - KEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SAKEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA2023-12-13PLASMA DERIVATIVE
Koate - KEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SAKEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA2023-12-12PLASMA DERIVATIVE
PROLASTIN-C - GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SAGRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA2022-02-25PLASMA DERIVATIVE

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-200THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT [GRIFOLS USA, LLC]29Unmatched20231222_b2a9f856-3ef7-8da4-920c-f738e4f1f7d7.zip
13533-200PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT [GRIFOLS USA, LLC]25Unmatched20220308_91edab72-c889-470e-8315-1798b5548dca.zip
13533-200KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.]23Unmatched20231228_2f77d685-e382-b2e7-2414-0d3a3448688a.zip
13533-200KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.]10Unmatched20231228_865df1e2-b4d1-dbf5-2899-a9c02df4d122.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Alpha-1-proteinase Inhibitor HumanACTIVE INGREDIENTF43I396OISPROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]13
Alpha-1-proteinase Inhibitor HumanACTIVE MOIETYF43I396OISPROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]13
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XPROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]13
Sodium PhosphateINACTIVE INGREDIENTSE337SVY37PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]13
Antihemophilic Factor HumanACTIVE INGREDIENT839MOZ74GKKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Antithrombin Iii HumanACTIVE INGREDIENTT0LTO7L82XTHROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]11
Antihemophilic Factor HumanACTIVE MOIETY839MOZ74GKKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Antithrombin Iii HumanACTIVE MOIETYT0LTO7L82XTHROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]11
Albumin (human)INACTIVE INGREDIENTZIF514RVZRKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
AluminumINACTIVE INGREDIENTCPD4NFA903KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Calcium ChlorideINACTIVE INGREDIENTM4I0D6VV5MKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
GlycineINACTIVE INGREDIENTTE7660XO1CKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
HistidineINACTIVE INGREDIENT4QD397987EKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Tri-n-butyl PhosphateINACTIVE INGREDIENT95UAS8YAF5KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11

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 13 of 56 · 1,113 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spleen Stim Liquescence 3028SPLEEN STIM LIQUESCENCEProfessional Complementary Health Formulas463b62a5-4d4f-445f-ba24-859195730cab2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Melancholy Drops 2002MELANCHOLY DROPSProfessional Complementary Health Formulas96d7f202-c19b-4914-96bb-9906ad781ad02026-01-08WarningsExact identifier
unii: 451W47IQ8X
Natrum Muriaticum 8009NATRUM MURIATICUMProfessional Complementary Health Formulasb4a48b58-28c0-4368-83e8-40ce52ae5f2b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Aletris Combination 9203ALETRIS COMBINATIONProfessional Complementary Health Formulas87ae7310-927b-48fe-b659-6f93dad623632026-01-08WarningsExact identifier
unii: 451W47IQ8X
Fertility Drops 2174FERTILITY DROPSProfessional Complementary Health Formulas78985992-bb47-4045-82f3-a6094e48d50a2026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Liver 7008RET LIVERProfessional Complementary Health Formulasd81bdbbd-5cfa-40e3-99f5-fd5368239fbe2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Herbal Diuretic Liquescence 3011HERBAL DIURETIC LIQUESCENCEProfessional Complementary Health Formulas5eee7f21-a3c4-46e0-a642-a4ca635734e32026-01-08WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEBECTON DICKINSON AND COMPANYd39b7307-df67-4e68-acb0-2eda5dc612152026-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
Immune BoostCHERRY PLUM, FERR PHOS, HORNBEAM, KALI SULPH, NAT MUR, OAK, OLIVE, THYMUS (CALF), ZINC MURSiddha Flower Essences LLCe8d44b65-47ef-ebc7-e053-2995a90a85832025-12-31WarningsExact identifier
unii: 451W47IQ8X
emotional detoxCALC PHOS, CALC SULPH, CASTANEA SATIVA, FLOS, ILEX AQUIFOLIUM, FLOS, KALI PHOS, NAT MUR, NAT PHOS, NAT SULPH, OLEA EUROPAEA, FLOS, ORNITHOGALUM UMBELLATUM, FLOSSiddha Flower Essences LLC385fb878-dd8f-40ae-82a3-874d6a6cceb22025-12-31WarningsExact identifier
unii: 451W47IQ8X
happy heartBROMUS RAMOSUS, FLOS, CALC FLUOR, CENTAURIUM UMBELLATUM, FLOS, FER PHOS, ILEX AQUIFOLIUM, FLOS, KALI PHOS, MAG PHOS, NAT MURSiddha Flower Essences LLCadb25966-b49a-48a9-a4ce-3ad7a2d7a7122025-12-31WarningsExact identifier
unii: 451W47IQ8X
digestAESCULUS HIPPOCASTANUM, BUD, CAL PHOS, CARPINUS BETULUS, FLOS, KALI PHOS, MAG PHOS, NAT MUR, NAT SULPH, ULMUS PROCERA, FLOSSiddha Flower Essences LLC99886d33-d8e0-4f58-89fa-e5071b30a98e2025-12-31WarningsExact identifier
unii: 451W47IQ8X
blood sugarCALC PHOS, CARPINUS BETULUS, FLOS, FERRUM PHOS, KALI PHOS, NAT MUR, NAT SULPH, OLEA EUROPAEA, FLOS, SILICEA, SINAPIS ARVENSIS, FLOSSiddha Flower Essences, LLC90ecd62b-c4bc-4bc4-a409-219929a49edb2025-12-31WarningsExact identifier
unii: 451W47IQ8X
mood and patienceCALC PHOS, CALC SULPH, CARPINUS BETULUS FLOS, FER PHOS, ILEX AQUIFOLIUM FLOS, IMPATIENS GLANDULIFERA FLOS, KALI PHOS, MAG PHOS, NAT MUR, NAT SULPHSiddha Flower Essences LLC03f55295-94f9-44f6-9386-ea2741a0f8be2025-12-31WarningsExact identifier
unii: 451W47IQ8X
sleepAESCULUS HIPPOCASTANUM, FLOS, FERRUM PHOS, KALI CARB, KALI PHOS, MAG PHOS, NAT MUR, POPULUS TERMULA, FLOS, PRUNUS CERASIFERA, FLOSSiddha Flower Essences LLCdc353895-3a58-475c-8afd-ab08b27b96c32025-12-31WarningsExact identifier
unii: 451W47IQ8X
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
throat and voiceCERATOSTIGMA WILLMOTTIANUM, FLOS, FERRUM PHOS, HOTTONIA PALUSTRIS, FLOS, KALI MUR, KALI PHOS, MAG PHOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT SULPH, SILICEASiddha Flower Essences LLC375ef37c-d5de-4762-a569-7304d98825202025-12-31WarningsExact identifier
unii: 451W47IQ8X
healthy hairCERTOSTIGMA WILLMOTTIANUM, FLOS, KALI SULPH, LARIX DECIDUA, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, SILICEASiddha Flower Essences LLC2b49fb7a-8d8b-4cef-8f8d-515c54451bfd2025-12-31WarningsExact identifier
unii: 451W47IQ8X
grief and lossCALC PHOS, CALC SULPH, CASTANEA SATIVA FLOS, IGNATIA AMARA, JUGLANS REGIA FLOS, KALI PHOS, NAT MUR, NAT SULPH, ORNITHOLAGUM UMBELLATUM FLOS, PHOS ACIDSiddha Flower Essences LLC1bb78196-303e-4c19-8bd9-d2add41ec52b2025-12-31WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.