NDC 50438-001

ROYAL Epsom Salt

Magnesium Sulfate

ROYAL Epsom Salt is a Oral Granule, For Solution in the Human Otc Drug category. It is labeled and distributed by Filo America. The primary component is Magnesium Sulfate.

Product ID50438-001_61c73a37-7089-4062-8a0b-cf4647dc1765
NDC50438-001
Product TypeHuman Otc Drug
Proprietary NameROYAL Epsom Salt
Generic NameMagnesium Sulfate
Dosage FormGranule, For Solution
Route of AdministrationORAL
Marketing Start Date2014-10-29
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart334
Labeler NameFilo America
Substance NameMAGNESIUM SULFATE
Active Ingredient Strength1 kg/kg
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50438-001-00

1.8 kg in 1 BAG (50438-001-00)
Marketing Start Date2014-10-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50438-001-00 [50438000100]

ROYAL Epsom Salt GRANULE, FOR SOLUTION
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-10-29

Drug Details

Active Ingredients

IngredientStrength
MAGNESIUM SULFATE1 kg/kg

OpenFDA Data

SPL SET ID:40eb04d2-fcc9-4ee2-8483-99699ea7e386
Manufacturer
RxNorm Concept Unique ID - RxCUI
  • 1053346
  • NDC Crossover Matching brand name "ROYAL Epsom Salt" or generic name "Magnesium Sulfate"

    NDCBrand NameGeneric Name
    50438-001ROYAL Epsom SaltROYAL Epsom Salt
    0363-0395Epsom SaltMagnesium sulfate
    0363-0942Epsom SaltMagnesium Sulfate
    0869-0602Epsom SaltMagnesium Sulfate
    11673-200Epsom SaltMagnesium Sulfate
    11673-602Epsom SaltMagnesium Sulfate
    21130-602Epsom SaltMagnesium Sulfate
    30142-602Epsom SaltMagnesium Sulfate
    11673-095Epsom Salt Magnesium SulfateMagnesium sulfate
    0395-0807Humco Epson SaltMagnesium Sulfate
    20276-330Lucky Epsom Saltmagnesium sulfate
    0404-9902Magnesium SulfateMagnesium Sulfate
    0409-1754Magnesium Sulfatemagnesium sulfate
    0409-2168Magnesium SulfateMAGNESIUM SULFATE

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