royal epsom salt

Generic: magnesium sulfate

Labeler: filo america
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name royal epsom salt
Generic Name magnesium sulfate
Labeler filo america
Dosage Form GRANULE, FOR SOLUTION
Routes
ORAL
Active Ingredients

magnesium sulfate, unspecified form 1 kg/kg

Manufacturer
Filo America

Identifiers & Regulatory

Product NDC 50438-001
Product ID 50438-001_48fdd749-9d9f-c41a-e063-6394a90a7158
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M007
Listing Expiration 2027-12-31
Marketing Start 2014-10-29

Pharmacologic Class

Classes
calculi dissolution agent [epc] increased large intestinal motility [pe] inhibition large intestine fluid/electrolyte absorption [pe] inhibition small intestine fluid/electrolyte absorption [pe] magnesium ion exchange activity [moa] osmotic activity [moa] osmotic laxative [epc] stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50438001
Hyphenated Format 50438-001

Supplemental Identifiers

RxCUI
1053346
UNII
DE08037SAB

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name royal epsom salt (source: ndc)
Generic Name magnesium sulfate (source: ndc)
Application Number M007 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 kg/kg
source: ndc
Packaging
  • 1.8 kg in 1 BAG (50438-001-00)
source: ndc

Packages (1)

50438-001-00 1.8 kg in 1 BAG (50438-001-00)

Ingredients (1)

magnesium sulfate, unspecified form (1 kg/kg)

Linked Drug Pages (1)

ROYAL Epsom Salt ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48fdd749-9d9f-c41a-e063-6394a90a7158", "openfda": {"unii": ["DE08037SAB"], "rxcui": ["1053346"], "spl_set_id": ["40eb04d2-fcc9-4ee2-8483-99699ea7e386"], "manufacturer_name": ["Filo America"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1.8 kg in 1 BAG (50438-001-00)", "package_ndc": "50438-001-00", "marketing_start_date": "20141029"}], "brand_name": "ROYAL Epsom Salt", "product_id": "50438-001_48fdd749-9d9f-c41a-e063-6394a90a7158", "dosage_form": "GRANULE, FOR SOLUTION", "pharm_class": ["Calculi Dissolution Agent [EPC]", "Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]", "Magnesium Ion Exchange Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "50438-001", "generic_name": "Magnesium Sulfate", "labeler_name": "Filo America", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ROYAL Epsom Salt", "active_ingredients": [{"name": "MAGNESIUM SULFATE, UNSPECIFIED FORM", "strength": "1 kg/kg"}], "application_number": "M007", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20141029", "listing_expiration_date": "20271231"}