miralax

Generic: polyethylene glycol 3350

Labeler: asclemed usa inc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name miralax
Generic Name polyethylene glycol 3350
Labeler asclemed usa inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 17 g/17g

Manufacturer
ASCLEMED USA INC.

Identifiers & Regulatory

Product NDC 76420-489
Product ID 76420-489_411a7a72-348c-4e5b-e063-6294a90a6c7e
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA022015
Listing Expiration 2026-12-31
Marketing Start 2007-02-01

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 76420489
Hyphenated Format 76420-489

Supplemental Identifiers

RxCUI
876193 876195
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
  • 10 PACKET in 1 CARTON (76420-489-10) / 17 g in 1 PACKET
  • 20 POUCH in 1 CARTON (76420-489-20) / 17 g in 1 POUCH
  • 24 PACKET in 1 CARTON (76420-489-24) / 17 g in 1 PACKET
  • 765 g in 1 BOTTLE, PLASTIC (76420-489-77)
  • 850 g in 1 BOTTLE, PLASTIC (76420-489-85)
source: ndc

Packages (5)

76420-489-10 10 PACKET in 1 CARTON (76420-489-10) / 17 g in 1 PACKET 76420-489-20 20 POUCH in 1 CARTON (76420-489-20) / 17 g in 1 POUCH 76420-489-24 24 PACKET in 1 CARTON (76420-489-24) / 17 g in 1 PACKET 76420-489-77 765 g in 1 BOTTLE, PLASTIC (76420-489-77) 76420-489-85 850 g in 1 BOTTLE, PLASTIC (76420-489-85)

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": "411a7a72-348c-4e5b-e063-6294a90a6c7e", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "unii": ["G2M7P15E5P"], "rxcui": ["876193", "876195"], "spl_set_id": ["e652042f-3707-4bf6-831d-d806638b7d85"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [{"sample": false, "description": "10 PACKET in 1 CARTON (76420-489-10)  / 17 g in 1 PACKET", "package_ndc": "76420-489-10", "marketing_start_date": "20251014"}, {"sample": false, "description": "20 POUCH in 1 CARTON (76420-489-20)  / 17 g in 1 POUCH", "package_ndc": "76420-489-20", "marketing_start_date": "20251014"}, {"sample": false, "description": "24 PACKET in 1 CARTON (76420-489-24)  / 17 g in 1 PACKET", "package_ndc": "76420-489-24", "marketing_start_date": "20251014"}, {"sample": false, "description": "765 g in 1 BOTTLE, PLASTIC (76420-489-77)", "package_ndc": "76420-489-77", "marketing_start_date": "20251014"}, {"sample": false, "description": "850 g in 1 BOTTLE, PLASTIC (76420-489-85)", "package_ndc": "76420-489-85", "marketing_start_date": "20251014"}], "brand_name": "MiraLAX", "product_id": "76420-489_411a7a72-348c-4e5b-e063-6294a90a6c7e", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "76420-489", "generic_name": "Polyethylene Glycol 3350", "labeler_name": "ASCLEMED USA INC.", "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": "20070201", "listing_expiration_date": "20261231"}