MiraLAX (polyethylene glycol 3350) NDC 11523-4357

NDC codes

FDA NDC Directory

Product NDC (as listed)11523-4357Labeler and product segments. Claims need a package NDC.

Product NDC at billing width11523-4357Add 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
11523-4357-2	11523435702	2 CARTON in 1 CARTON (11523-4357-2) / 20 PACKET in 1 CARTON / 17 g in 1 PACKETMarketed from Feb 1, 2007
11523-4357-3	11523435703	2 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (11523-4357-3) / 578 g in 1 BOTTLE, PLASTICMarketed from Feb 1, 2007
11523-4357-5	11523435705	24 PACKET in 1 CARTON (11523-4357-5) / 17 g in 1 PACKETMarketed from May 1, 2018 · Sample package

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): MiraLAX
Generic name (nonproprietary): polyethylene glycol 3350
Active ingredients: Polyethylene glycol 3350 — 17 g/17g
Dosage form: Powder, For solution
Route: Oral
Labeler: Bayer HealthCare LLC.
Product type: Over-the-counter drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022015
Marketing start: Feb 1, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 11523-4357_51040c1b-71bf-bb83-e063-6294a90aca4eSPL ID 51040c1b-71bf-bb83-e063-6294a90aca4eSPL set ID d69ce3d4-7ca4-4fe3-b49e-6655e48d6963RxCUI 876193, 876195UNII G2M7P15E5PUPC 0041100820716, 0041100564542
Pharmacologic class: 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

N411523435702 followed by a unit qualifier and the quantity

Package 11523-4357-02. 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 May 4, 2026.

Indications (excerpt from the label)

Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022015

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

FDA NDC Directory listings under NDA 022015
Product	Strength	Form · route	Labeler	Product NDC
MiraLAXpolyethylene glycol 3350	Polyethylene glycol 3350 17 g/17g	Powder, For solutionOral	Bayer HealthCare LLC.	11523-7268
MiraLAXpolyethylene glycol 3350	Polyethylene glycol 3350 17 g/17g	Powder, For solutionOral	ASCLEMED USA INC.	76420-489
MiraLAXpolyethylene glycol 3350	Polyethylene glycol 3350 17 g/17g	Powder, For solutionOral	Cardinal Health 107, LLC	55154-5035