What is NDC 50438-001?

50438-001 is the product NDC for ROYAL Epsom Salt (magnesium sulfate), Magnesium sulfate, Unspecified form 1 kg/kg granule, for solution, listed with the FDA by Filo America. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

ROYAL Epsom Salt (Magnesium Sulfate).

What is the active ingredient?

Magnesium sulfate, Unspecified form.

Filo America, NDC labeler code 50438. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for ROYAL Epsom Salt?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

ROYAL Epsom Salt NDC 50438-001 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50438-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50438-0001Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50438-001-00	5043800010050438000100	1.8 kg in 1 BAG (50438-001-00)Marketed from Oct 29, 2014

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): ROYAL Epsom Salt
Generic name (nonproprietary): magnesium sulfate
Active ingredients: Magnesium sulfate, Unspecified form — 1 kg/kg
Dosage form: Granule, For solution
Route: Oral
Labeler: Filo AmericaNDC labeler code 50438
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 007
Marketing start: Oct 29, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 50438-001_48fdd749-9d9f-c41a-e063-6394a90a7158SPL ID 48fdd749-9d9f-c41a-e063-6394a90a7158SPL set ID 40eb04d2-fcc9-4ee2-8483-99699ea7e386RxCUI 1053346UNII DE08037SAB
Pharmacologic class: Calculi Dissolution Agent; Osmotic Laxative

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450438000100 followed by a unit qualifier and the quantity

Package 50438-0001-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 22, 2026.

Indications (excerpt from the label)

Uses for relief of occasional constipation (irregularity) this product generally produces a bowel movement in 1/2 to 6 hours

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50438-001

What is NDC 50438-001?: 50438-001 is the product NDC for ROYAL Epsom Salt (magnesium sulfate), Magnesium sulfate, Unspecified form 1 kg/kg granule, for solution, listed with the FDA by Filo America. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: ROYAL Epsom Salt (Magnesium Sulfate).
What is the active ingredient?: Magnesium sulfate, Unspecified form.
Who is the labeler?: Filo America, NDC labeler code 50438. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for ROYAL Epsom Salt?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under M 007

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 007
Product	Strength	Form · route	Labeler	Product NDC
Stool Softenerdocusate sodium	Docusate sodium 100 mg/1	Capsule, Liquid filledOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-938
Glycerin	Glycerin 1 g/1	SuppositoryRectal	Chain Drug Consortium LLC	68016-161
Bisacodyl	Bisacodyl 10 mg/1	SuppositoryRectal	CVS Pharmacy	69842-816
Mineral oil	Mineral oil 100 mg/100mL	OilOral	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	49035-035
Epsom Saltmagnesium sulfate	Magnesium sulfate, Unspecified 1 g/g	GranuleOral, Topical	Whole Foods Market	42681-6412
Stratuscare Glycerin Laxative Pediatricglycerin	Glycerin 1 g/1	SuppositoryRectal	Stratus Pharmaceuticals	58980-409
Senokotstandardized senna concentrate	Sennosides 8.6 mg/1	TabletOral	Atlantis Consumer Healthcare, Inc.	67618-300
Senna	Sennosides a and b 8.8 mg/5mL	SolutionOral	Rugby Laboratories	0536-1483
Milk Of Magnesia Cherrymagnesium hydroxide	Magnesium hydroxide 1200 mg/15mL	LiquidOral	TOP CARE (TOPCO ASSOCIATES LLC)	36800-684
Epsom Saltmagnesium sulfate	Magnesium sulfate, Unspecified 1 g/g	GranuleOral, Topical	Whole Foods Market	42681-6413
Stratuscare Adult Glyceringlycerin	Glycerin 2 g/1	SuppositoryRectal	Stratus Pharmaceuticals	58980-410
Phillips Fresh Mint Milk Of Magnesia	Magnesium hydroxide 1200 mg/15mL	LiquidOral	Bayer HealthCare LLC.	0280-0031
Senokot-Sstandardized senna concentrate and docusate sodium	Sennosides 8.6 mg/1; Docusate sodium 50 mg/1	TabletOral	Atlantis Consumer Healthcare, Inc.	67618-310
Senexon-Sdocusate sodium 50mg and sennosides 8.6mg	Sennosides 8.6 mg/1; Docusate sodium 50 mg/1	Tablet, Film coatedOral	RUGBY LABORATORIES	0536-1247
Equate Kids Gentle Laxative SCmagnesium hydroxide	Magnesium hydroxide 1200 mg/1	Tablet, ChewableOral	Walmart	79903-252
Stratuscare Bisacodylbisacodyl	Bisacodyl 10 mg/1	SuppositoryRectal	Stratus Pharmaceuticals	58980-415
Epsom Saltmagnesium sulfate	Magnesium sulfate heptahydrate 1 g/g	Granule, For solutionOral, Topical	Vi-Jon, LLC	0869-0602
Fleetbisacodyl	Bisacodyl 5 mg/1	Tablet, CoatedOral	C.B. Fleet Company, Inc.	0132-0401
Stool Softenerdocusate sodium	Docusate sodium 100 mg/1	TabletOral	Geri-Care Pharmaceuticals, Corp	57896-421
Stool Softener Extra Strengthdocusate sodium	Docusate sodium 250 mg/1	Capsule, Liquid filledOral	CVS Pharmacy	69842-740

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ROYAL Epsom Salt (Magnesium sulfate) NDC 50438-001