FDA.reportPublic FDA data

NDC 57319-528 - AMINO ACID ORAL

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
57319-528
Package NDCs from labels
57319-528-04
Manufacturer
Clipper Distributing Company, LLC | Sparhawk Laboratories, Inc.
Effective date
2024-06-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMINO ACID ORAL SOLUTIONClipper Distributing Company, LLC | Sparhawk Laboratories, Inc.2024-06-05OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57319-528-04AMINO ACID ORAL500 mL in 1 BOTTLESOLUTION5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57319-528AMINO ACID ORAL (AMINO ACID) SOLUTION [CLIPPER DISTRIBUTING COMPANY, LLC]11 package rows20240606_9f2f4fa6-8725-4c70-bab0-b520fd5c8f5e.zip

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 27 of 36 · 703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDELupin Pharmaceuticals,Inc.fe08221d-74d5-490a-8db4-eaf3ed20b2892024-01-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirst7d94995b-9e2a-0345-e053-2991aa0a62d02024-01-28Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta14ca7d9-de30-a303-e053-2a95a90a53042024-01-27Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea2024-01-25Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEAmerican Health Packaginga67f5ba7-ac23-4bdc-9563-cb7fd049a9512024-01-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Lung DrainageKALI MURIATICUM, CARBO VEGETABILIS, LUNG (SUIS), MYCOPLASMA PNEUMONIAE, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HAEMOPHILUS INFLUENZAE B, PNEUMOCOCCINUM, OXYGENIUM, ANTIMONIUM ARSENICICUM, CAMPHORA, CHELIDONIUM MAJUS, CHININUM MURIATICUM, CUPRUM METALLICUM, IPECACUANHA, LOBELIA PURPURESCENS, PHOSPHORUS, SENEGA OFFICINALIS, STANNUM METALLICUM, VERATRUM VIRIDEDeseret Biologicals, Inc.8fdb37fb-f3df-4dae-abb4-1f3a71c1c6832024-01-15WarningsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDESun Pharmaceutical Industries, Inc.4d90d03d-7f0e-4d49-9e80-628dbc7165c02024-01-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDESun Pharmaceutical Industries, Inc.8ed8ea55-8b15-f718-e053-2a95a90a587a2024-01-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: SK47B8698T
D09 SNS-DRNAMBROSIA ARTEMISIAEFOLIA, ARALIA RACEMOSA, ARNICA MONTANA, CALENDULA OFFICINALIS, CHROMICUM ACIDUM, ECHINACEA PURPUREA, EUCALYPTOL, KALI BICHROMICUM, KALI MURIATICUM, KALI SULPHURICUM, LAC VACCINUM, MERCURIUS IODATUS FLAVUS, MERCURIUS SULPHURATUS RUBER, NATRUM ARSENICICUM, ROSA DAMASCENA, SABADILLA, SANGUINARINUM NITRICUM, SYMPHYTUM OFFICINALEApex Energetics Inc.bc7efab4-7791-9759-e053-2a95a90a31092024-01-08WarningsExact identifier
unii: 660YQ98I10
N02 PETROCHEMACETONE, ANILINUM, BENZINUM, BENZOPYRENE, CARBO VEGETABILIS, CARBOLICUM ACIDUM, CARBON TETRACHLORIDE, ETHER, MAGNESIA SULPHURICA, METHYL ALCOHOL, PETROLEUM, PHENOLPHTHALEIN, PHOSPHORUS, PICRICUM ACIDUM, PINE TAR, PLUMBOUS CHLORIDE, PLUMBUM METALLICUM, SULPHONALUM, SULPHURICUM ACIDUM, TEREBINTHINA, TRICHLOROETHYLENE, VANADIUM METALLICUMApex Energetics Inc.ba5e7801-667b-ab7c-e053-2995a90a788c2024-01-08WarningsExact identifier
unii: SK47B8698T
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEProficient Rx LPd0ce0bdf-5f24-4093-813f-881c61d7fcc72024-01-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDE EXTENDED RELEASEPOTASSIUM CHLORIDEAdare Pharmaceuticals Inc22edb0e6-4e45-4e91-aead-3581cca293a02023-12-20Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Humco Epson SaltMAGNESIUM SULFATEHumco Holding Group, Inc.7a9d1b77-6c39-46f1-86f2-4059dde20f852023-12-15WarningsExact identifier
unii: SK47B8698T
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions5aa0adf8-7b84-4cb0-be31-5c3333a6cc442023-12-11Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions5c4b0be5-625e-435f-9d2c-9d8fb407a8ea2023-12-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutionsd033c3b3-3ed6-4f23-a555-bae40cf0c48f2023-12-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
RenotoxTRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,BioActive Nutritional, Inc.b501f7bc-fa3a-494e-bf95-6779a3169a492023-11-17WarningsExact identifier
unii: 660YQ98I10
Magnesia sulphuricaMAGNESIUM SULFATE HEPTAHYDRATEBoiron7d77a15c-c9ef-7778-e053-2991aa0aa0b62023-11-14Exact identifier
unii: SK47B8698T

Reported adverse events (FAERS/openFDA)#

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