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 1 of 37 · 722 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEREMEDYREPACK INC.ace1eb11-b925-405a-b772-58c60b3ca7d42026-09-09Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.8cf6943f-16e8-4521-863c-09bb0b55e2a92026-09-09Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Epsom SaltMAGNESIUM SULFATETarget Corporation87f98e6c-a3a1-4ca5-bd56-977e38f489142026-09-04Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
BMNP Kali MurKALIUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a546950-3f03-7abf-e063-6294a90a19682026-08-31WarningsExact identifier
unii: 660YQ98I10
DextroseDEXTROSE MONOHYDRATEREMEDYREPACK INC.b8b77421-d687-45aa-82f6-d49bce644c102026-08-31Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEREMEDYREPACK INC.2c407aaf-5d95-49ff-a5db-f1d7b51903342026-08-27Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEMedical Purchasing Solutions, LLC5a0f9db9-b8be-c923-e063-6394a90a7dd72026-08-27Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Epsom SaltMAGNESIUM SULFATECardinal Health, 110 dba Leaderd27dc1cc-5e17-40d3-84fe-c1792552cfd52026-08-25Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Electrolyte PlusKALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUMDeseret Biologicals, Inc.e3564733-8b88-4753-9077-9d74004d8ec92026-08-25WarningsExact identifier
unii: HG18B9YRS7
unii: 660YQ98I10
Magnesium Sulfate in WaterMAGNESIUM SULFATEWG Critical Care, LLC752f55bb-c4ca-4545-94b3-3deea66888d42026-08-25Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.22ca78b4-f5a3-4144-cf89-5f633acf1e6d2026-08-24Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEREMEDYREPACK INC.8c6b8b3d-9c04-4ed7-86b8-89065b6bf50d2026-08-24Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Potassium ChloridePOTASSIUM CHLORIDECardinal Health 107, LLCea55ded1-e076-43de-ad3c-c75e7d0a4ebc2026-08-24Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Magnesium Sulfate in DextroseMAGNESIUM SULFATE IN DEXTROSEHospira, Inc.03ebeabb-8386-4af4-3086-bdf3c3fc4a5a2026-08-24Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE ORALCardinal Health 107, LLCfea3ae21-3395-437e-b773-b180e1c988012026-08-24Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sodium AcetateSODIUM ACETATEAmneal Pharmaceuticals Private Limited0c0b11da-d7fc-4b4c-b0ef-d97af8e88abf2026-08-21Warnings, Adverse reactionsExact identifier
unii: NVG71ZZ7P0
Potassium ChloridePOTASSIUM CHLORIDECoupler LLC598f61d7-a665-5d02-e063-6394a90a89052026-08-21Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: 660YQ98I10
TrophAmineISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINEB. Braun Medical Inc.cb6d23ff-3ec5-445a-acbe-f88fd57949bf2026-08-19Warnings, Adverse reactionsExact identifier
unii: HG18B9YRS7
Epsom SaltEPSOM SALTAmerisourceBergen (Good Neighbor Pharmacy) 46122d22fb02f-09c4-476a-b6d6-d3a2fd30049d2026-08-18WarningsExact identifier
unii: SK47B8698T

Reported adverse events (FAERS/openFDA)#

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