FDA.reportPublic FDA data

NDC 0053-6243 - Mononine

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
0053-6243
Package NDCs from labels
0053-6243-01
Manufacturer
CSL Behring LLC
Effective date
2020-12-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mononine - CSL Behring LLCCSL Behring LLC2020-12-10PLASMA DERIVATIVE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
coagulation factor IX humanACTIVE INGREDIENT6U90Y1795TMONONINE (COAGULATION FACTOR IX HUMAN) KIT [CSL BEHRING LLC]10
coagulation factor IX humanACTIVE MOIETY6U90Y1795TMONONINE (COAGULATION FACTOR IX HUMAN) KIT [CSL BEHRING LLC]10
HistidineINACTIVE INGREDIENT4QD397987EMONONINE (COAGULATION FACTOR IX HUMAN) KIT [CSL BEHRING LLC]10
hydrochloric acidINACTIVE INGREDIENTQTT17582CBMONONINE (COAGULATION FACTOR IX HUMAN) KIT [CSL BEHRING LLC]10
MannitolINACTIVE INGREDIENT3OWL53L36AMONONINE (COAGULATION FACTOR IX HUMAN) KIT [CSL BEHRING LLC]10
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HMONONINE (COAGULATION FACTOR IX HUMAN) KIT [CSL BEHRING LLC]10
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XMONONINE (COAGULATION FACTOR IX HUMAN) KIT [CSL BEHRING LLC]10
sodium hydroxideINACTIVE INGREDIENT55X04QC32IMONONINE (COAGULATION FACTOR IX HUMAN) KIT [CSL BEHRING LLC]10

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 16 of 54 · 1,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDESOLA Pharmaceuticals, LLC4d0bfd28-460a-48ba-bd17-cf75e56d62f42025-12-09Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Vamousse Lice TreatmentPEDICULICIDEAlliance Pharma Inc.75db3fab-5523-4880-e053-2a91aa0a925e2025-12-05WarningsExact identifier
unii: 451W47IQ8X
V HPANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUREnergique, Inc.cba32ae8-45af-494c-ac1a-fea4b10f18602025-12-04WarningsExact identifier
unii: 451W47IQ8X
THE FLOWER REMEDY Happy HeartGENTIANELLA AMARELLA, ULEX EUROPAEUS, ILEX AQUIFOLIUM, LONICERA CAPRIFOLIUM, SINAPIS ARVENSIS, ORNITHOGALUM UMBELLATUM, CASTANEA SATIVA, SALIX VITELLINA, IGNATIA AMARA, NATRUM MURIATICUMThe Flower Remedy6decd8fe-7593-4421-926c-f924002400322025-12-03WarningsExact identifier
unii: 451W47IQ8X
BM BIO28 ICING SUGARCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited3e855f3b-c73d-a153-e063-6394a90ad63a2025-12-02WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro3e85a931-57f6-2a55-e063-6294a90ac1802025-12-02WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA: Bestmade Natural Products Micro3e46ee90-2c2c-0a70-e063-6294a90a576a2025-12-02WarningsExact identifier
unii: 451W47IQ8X
BM Nat MurNATRIUM MURIATICUMBM Private Limited37b12318-dff9-e32a-e063-6394a90a18e82025-12-02WarningsExact identifier
unii: 451W47IQ8X
BM Nat Mur Icing SugarNATRUM MURIATICUM ICING SUGARBM Private Limited37c27f80-7689-c5a1-e063-6294a90a619b2025-12-02WarningsExact identifier
unii: 451W47IQ8X
Walgreens SalineNASALWALGREEN COMPANY147e45c8-1e71-4c06-89f1-42e9f96833662025-12-01WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Mist MeijerSODIUM CHLORIDEMeijer, Inc.445c8f4f-0519-0764-e063-6294a90a8b392025-12-01WarningsExact identifier
unii: 451W47IQ8X
Walgreen SalineNASALWALGREENS CO.ee264d8b-0bb2-472a-907c-6a6291f154cd2025-11-26WarningsExact identifier
unii: 451W47IQ8X
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Natural Eyes Floaters ReliefCHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEATRP Company445dc831-195e-4b25-e063-6294a90a6efd2025-11-24WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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