epsom salt

Generic: magnesium sulfate

Labeler: top care (topco associates llc)
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name epsom salt
Generic Name magnesium sulfate
Labeler top care (topco associates llc)
Dosage Form GRANULE
Routes
ORAL TOPICAL
Active Ingredients

magnesium sulfate, unspecified 1 g/g

Manufacturer
TOP CARE (Topco Associates LLC)

Identifiers & Regulatory

Product NDC 36800-395
Product ID 36800-395_a34b111e-721e-46c0-a4de-90b8df1868a0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M007
Listing Expiration 2026-12-31
Marketing Start 2014-04-30

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 36800395
Hyphenated Format 36800-395

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

Resolved Composition

Strengths
  • 1 g/g
source: ndc
Packaging
  • 454 g in 1 CARTON (36800-395-01)
  • 1810 g in 1 CARTON (36800-395-04)
  • 454 g in 1 POUCH (36800-395-10)
  • 1814 g in 1 POUCH (36800-395-40)
source: ndc

Packages (4)

36800-395-01 454 g in 1 CARTON (36800-395-01) 36800-395-04 1810 g in 1 CARTON (36800-395-04) 36800-395-10 454 g in 1 POUCH (36800-395-10) 36800-395-40 1814 g in 1 POUCH (36800-395-40)

Ingredients (1)

magnesium sulfate, unspecified (1 g/g)

Linked Drug Pages (1)

Epsom Salt ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL", "TOPICAL"], "spl_id": "a34b111e-721e-46c0-a4de-90b8df1868a0", "openfda": {"unii": ["DE08037SAB"], "rxcui": ["1053346"], "spl_set_id": ["b1222ba6-390d-478d-905b-994fff4d6d58"], "manufacturer_name": ["TOP CARE (Topco Associates LLC)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "454 g in 1 CARTON (36800-395-01)", "package_ndc": "36800-395-01", "marketing_start_date": "20140430"}, {"sample": false, "description": "1810 g in 1 CARTON (36800-395-04)", "package_ndc": "36800-395-04", "marketing_start_date": "20140430"}, {"sample": false, "description": "454 g in 1 POUCH (36800-395-10)", "package_ndc": "36800-395-10", "marketing_start_date": "20140430"}, {"sample": false, "description": "1814 g in 1 POUCH (36800-395-40)", "package_ndc": "36800-395-40", "marketing_start_date": "20140430"}], "brand_name": "Epsom Salt", "product_id": "36800-395_a34b111e-721e-46c0-a4de-90b8df1868a0", "dosage_form": "GRANULE", "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": "36800-395", "generic_name": "Magnesium sulfate", "labeler_name": "TOP CARE (Topco Associates LLC)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Epsom Salt", "active_ingredients": [{"name": "MAGNESIUM SULFATE, UNSPECIFIED", "strength": "1 g/g"}], "application_number": "M007", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140430", "listing_expiration_date": "20261231"}