FDA.reportPublic FDA data

NDC 50989-101 - Double A 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
50989-101
Package NDCs from labels
50989-101-25, 50989-101-17
Manufacturer
Vedco, Inc.
Effective date
2017-01-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Double "A" SolutionVedco, Inc.2017-01-17OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50989-101-17Double AORAL1000 mL in 1 BOTTLESOLUTION10002
50989-101-25Double AORAL500 mL in 1 BOTTLESOLUTION5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50989-101DOUBLE A ORAL (AMINO ACID) SOLUTION [VEDCO, INC.]22 package rows20170117_765ccb6c-53d4-40ad-9a34-5e025fb79bf2.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 26 of 36 · 703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
magnesium sulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLC43d658b1-2b19-44be-a346-cac11fd600b32024-04-24Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Magnesium Sulfate in 5% DextroseMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCcea3f48b-375a-415a-a341-435c09719f7c2024-04-24Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Magnesium Sulfate in 5% DextroseMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCfdffb339-89d1-4495-97b7-d9422d68b3d52024-04-24Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
GlyregACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCADeseret Biologicals, Inc28e670ca-ed35-4256-af20-74c25dc180992024-04-23WarningsExact identifier
unii: SK47B8698T
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch Prepack65e30d1a-50e9-4b84-ad4d-daaea91eab4b2024-04-09Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Oral HealthANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, BORAX, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CHAMOMILLA, CINCHONA OFFICINALIS, DISCUS INTERVERTEBRALIS SUIS, STREPTOCOCCUS DYSGALACTIAE DNA, STREPTOCOCCUS MUTANS DNA, STREPTOCOCCUS PNEUMONIAE DNA, ECHINACEA PURPUREA, IGNATIA AMARA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NUX MOSCHATA, ORAL MUCOSA (SUIS), OXYGENIUM, SAMBUCUS NIGRA, SEPIA, STAPHYLOCOCCUS AUREUS,Deseret Biologicals, Inc.6f66ff40-6e0e-4a35-963c-965c65df76eb2024-04-01WarningsExact identifier
unii: 660YQ98I10
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEB. Braun Medical Inc.59ccc717-c374-41c0-be58-9647df8811602024-03-26Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POKONZAPOTASSIUM CHLORIDECarwin Pharmaceutical Associates, LLC7c5cc705-e5da-4487-86c9-9d545a95afb42024-03-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Balanced SaltSODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATEB. Braun Medical Inc.74ab8883-0a5f-46b4-8998-9358f6fd4ef42024-03-13Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEKesin Pharma Corporation25c2b417-eeea-4ba6-8eb9-a7d8a08c60932024-03-12Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
HerXECHINACEA (ANGUSTIFOLIA), ARNICA MONTANA, HYDRASTIS CANADENSIS, LEDUM PALUSTRE, MAGNESIA SULPHURICA, KALMIA LATIFOLIA, ARSENICUM ALBUM, COCCULUS INDICUS, PHOSPHORUSDeseret Biologicals, Incae270bbf-40c8-44e9-91ea-ee5ddbdd9f542024-03-11WarningsExact identifier
unii: SK47B8698T
Oral HealthBORAX, BRYONIA (ALBA), ECHINACEA PURPUREA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MURIATICUM ACIDUM, DISCUS INTERVERTEBRALIS SUIS, ORAL MUCOSA (SUIS), ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CHAMOMILLA, CINCHONA OFFICINALIS, NUX MOSCHATA, SAMBUCUS NIGRA, SEPIA, MERCURIUS SOLUBILIS, CALCAREA PHOSPHORICA, IGNATIA AMARA, OXYGENIUM, CANDIDA ALBICANS, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS MUTANSDeseret Biologicals, Inc.81ffb30f-5255-4e16-ba9d-b0de909aa5572024-03-05WarningsExact identifier
unii: 660YQ98I10
Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERAthenex Pharmaceutical Division, LLC.70776952-a340-4405-9cf0-f0988ff8097b2024-03-04Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Dextrose monohydrateDEXTROSE MONOHYDRATEHF Acquisition Co LLC, DBA HealthFirstd7c4f9eb-9b89-c5a3-e053-2a95a90a28a22024-02-22Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
50% DEXTROSE50% DEXTROSEHF Acquisition Co LLC, DBA HealthFirst763b1cb8-1151-5f59-e053-2991aa0a4e012024-02-22Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DEXTROSEDEXTROSEHF Acquisition Co LLC, DBA HealthFirst75c902e8-50e7-a337-e053-2991aa0a20932024-02-19Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Potassium ChloridePOTASSIUM CHLORIDEProficient Rx LP61daa681-05a0-4b2f-a6d0-c6fc1044f5212024-02-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Ear RingingACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATANewton Laboratories, Inc.1043debe-8787-a2f5-e063-6294a90a2a662024-01-31WarningsExact identifier
unii: 660YQ98I10
Ear RingingACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATANewton Laboratories, Inc.1045ab27-c4d5-fcbd-e063-6294a90a51762024-01-31WarningsExact identifier
unii: 660YQ98I10
TinnitusACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATANewton Laboratories, Inc.10462aaa-96d4-4ba3-e063-6294a90a79152024-01-31WarningsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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