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 11 of 36 · 703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.018fc687-1fba-202e-e063-6294a90a5c9a2025-11-17Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Natural Relief Diarrhea ReliefALOE, CITRULLUS COLOCYNTHIS, CROTON TIGLIUM, LYCOPODIUM CLAVATUM, MAGNESIUM SULFATE HEPTAHYDRATE, PHOSPHORIC ACID, THUJA OCCIDENTALISTRP Company436de0c5-acd6-e32b-e063-6394a90aa2752025-11-12WarningsExact identifier
unii: SK47B8698T
Potassium ChloridePOTASSIUM CHLORIDEBluePoint Laboratories3709ee9a-f885-4a75-ab51-36e9e1ef04272025-11-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEBluepoint Laboratoriesd605ca36-2bfa-42cb-a46c-8ecb3162994e2025-11-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
LUMOe SKIN1 Skin RemedyKALI MURIATICUM, PRUNUS SPINOSA, SILICEA, SARSAPARILLAApplied Bioenergetics, LLCd4d7fd2f-66bf-407d-ad36-2462e880b9f52025-11-10WarningsExact identifier
unii: 660YQ98I10
LUMO Heal Seasonal Flu CompanionARSENICUM ALBUM, EUPATORIUM PERFOLIATUM, KALI MURIATICUM, STICTA PULMONARIAApplied Bioenergetics, LLCda6b6258-f91e-4283-aeb2-54e7885a80b82025-11-10WarningsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEHenry Schein, Inc.8367a2ae-dfd9-4515-838c-529920291ca02025-11-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack2feda15e-f325-41fe-a442-41a8cc62b8552025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEA-S Medication Solutionsd486f982-a7d3-463d-a68d-89365ddaf5bb2025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium chloridePOTASSIUM CHLORIDEA-S Medication Solutions4a2173ba-556b-4ad7-be81-4da79b7394902025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEA-S Medication Solutionsde335131-bb8a-44e5-89fa-1478edbcdc0e2025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack6fc9eef0-3dfc-4344-85c7-9f11d9b99b652025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEA-S Medication Solutionsedb6c987-e2c3-421f-8a8d-849c9e17ace82025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack1b64b0c9-31a2-4ee7-8818-66de906ebeda2025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.d3d29c8f-c326-4097-814a-7f4e08c670682025-11-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDEB. Braun Medical Inc.01721071-af03-4894-95c1-10b8bc64b8882025-11-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.190da07e-a616-46e6-b4e5-1c0ba39306e52025-11-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
unii: LX22YL083G
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions0ac9b8dc-0c8e-4cdc-ab9d-bd8cab4f49582025-11-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.f6d82772-638c-4584-b9d3-8833669f59632025-11-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium chloridePOTASSIUM CHLORIDEA-S Medication Solutionseb6b608f-5e51-4bc9-8339-c5d5264cba982025-11-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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