miralax

Generic: polyethylene glycol 3350

Labeler: cardinal health 107, llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name miralax
Generic Name polyethylene glycol 3350
Labeler cardinal health 107, llc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 17 g/17g

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-5035
Product ID 55154-5035_a30d3776-09c8-41aa-9282-ba2486632e07
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA022015
Listing Expiration 2026-12-31
Marketing Start 2009-02-23

Pharmacologic Class

Established (EPC)
osmotic laxative [epc]
Mechanism of Action
osmotic activity [moa]
Physiologic Effect
stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551545035
Hyphenated Format 55154-5035

Supplemental Identifiers

RxCUI
876193 876195
UPC
0055154503563
UNII
G2M7P15E5P
NUI
N0000010288 N0000175811 N0000009871

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 miralax (source: ndc)
Generic Name polyethylene glycol 3350 (source: ndc)
Application Number NDA022015 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 17 g/17g
source: ndc
Packaging
  • 6 PACKET in 1 BAG (55154-5035-6) / 17 g in 1 PACKET
source: ndc

Packages (1)

55154-5035-6 6 PACKET in 1 BAG (55154-5035-6) / 17 g in 1 PACKET

Ingredients (1)

polyethylene glycol 3350 (17 g/17g)

Linked Drug Pages (1)

MiraLAX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a30d3776-09c8-41aa-9282-ba2486632e07", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "upc": ["0055154503563"], "unii": ["G2M7P15E5P"], "rxcui": ["876193", "876195"], "spl_set_id": ["1771d3bf-954d-49ea-b260-3d356e5dcfa5"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "6 PACKET in 1 BAG (55154-5035-6)  / 17 g in 1 PACKET", "package_ndc": "55154-5035-6", "marketing_start_date": "20090223"}], "brand_name": "MiraLAX", "product_id": "55154-5035_a30d3776-09c8-41aa-9282-ba2486632e07", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "55154-5035", "generic_name": "Polyethylene Glycol 3350", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "MiraLAX", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "17 g/17g"}], "application_number": "NDA022015", "marketing_category": "NDA", "marketing_start_date": "20090223", "listing_expiration_date": "20261231"}