Comfortlax (polyethylene glycol 3350) NDC 55319-056

NDC codes

FDA NDC Directory

Product NDC (as listed)55319-056Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55319-0056Add 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
55319-056-24	55319005624	119 g in 1 BOTTLE, PLASTIC (55319-056-24)Marketed from Sep 4, 2024
55319-056-27	55319005627	510 g in 1 BOTTLE, PLASTIC (55319-056-27)Marketed from Sep 4, 2024
55319-056-33	55319005633	238 g in 1 BOTTLE, PLASTIC (55319-056-33)Marketed from Sep 4, 2024

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): Comfortlax
Generic name (nonproprietary): polyethylene glycol 3350
Active ingredients: Polyethylene glycol 3350 — 17 g/17g
Dosage form: Powder, For solution
Route: Oral
Labeler: Family Dollar Stores, LLC
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209017
Marketing start: Sep 4, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 55319-056_92049a0c-1ad7-4741-b82f-93995f3b96a3SPL ID 92049a0c-1ad7-4741-b82f-93995f3b96a3SPL set ID 02a44a41-0039-f6ec-e063-6394a90ae6f1RxCUI 876193, 2695451UNII G2M7P15E5PUPC 0032251948893
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

N455319005624 followed by a unit qualifier and the quantity

Package 55319-0056-24. 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 Apr 23, 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 ANDA 209017

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

FDA NDC Directory listings under ANDA 209017
Product	Strength	Form · route	Labeler	Product NDC
Polyethylene Glycol 3350	Polyethylene glycol 3350 17 g/17g	Powder, For solutionOral	Aurobindo Pharma Limited	84386-125
365 WHOLE FOODS MARKET Polyethylene Glycol 3350polyethylene glycol 3350	Polyethylene glycol 3350 17 g/17g	Powder, For solutionOral	Whole Foods Market, Inc.	42681-0059
Polyethylene Glycol 3350	Polyethylene glycol 3350 17 g/17g	Powder, For solutionOral	Aurohealth LLC	58602-805
Polyethylene Glycol 3350	Polyethylene glycol 3350 17 g/17g	Powder, For solutionOral	CARDINAL HEALTH 110, LLC. DBA LEADER	70000-0699