miralax

Generic: polyethylene glycol 3350

Labeler: bayer healthcare llc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name miralax
Generic Name polyethylene glycol 3350
Labeler bayer healthcare llc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 17 g/17g

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 11523-7268
Product ID 11523-7268_3ac22f1f-b34c-0c18-e063-6394a90a9742
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 115237268
Hyphenated Format 11523-7268

Supplemental Identifiers

RxCUI
876193 876195
UPC
0041100820716 0041100564542
UNII
G2M7P15E5P
NUI
N0000010288 N0000175811 N0000009871

Packaging Origin

Original Packager
true

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 (11523-7268-3) / 17 g in 1 PACKET
  • 765 g in 1 BOTTLE, PLASTIC (11523-7268-4)
  • 850 g in 1 BOTTLE, PLASTIC (11523-7268-5)
  • 24 PACKET in 1 CARTON (11523-7268-8) / 17 g in 1 PACKET
  • 20 POUCH in 1 CARTON (11523-7268-9) / 17 g in 1 POUCH
source: ndc

Packages (5)

11523-7268-3 10 PACKET in 1 CARTON (11523-7268-3) / 17 g in 1 PACKET 11523-7268-4 765 g in 1 BOTTLE, PLASTIC (11523-7268-4) 11523-7268-5 850 g in 1 BOTTLE, PLASTIC (11523-7268-5) 11523-7268-8 24 PACKET in 1 CARTON (11523-7268-8) / 17 g in 1 PACKET 11523-7268-9 20 POUCH in 1 CARTON (11523-7268-9) / 17 g in 1 POUCH

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": "3ac22f1f-b34c-0c18-e063-6394a90a9742", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "upc": ["0041100820716", "0041100564542"], "unii": ["G2M7P15E5P"], "rxcui": ["876193", "876195"], "spl_set_id": ["d69ce3d4-7ca4-4fe3-b49e-6655e48d6963"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 PACKET in 1 CARTON (11523-7268-3)  / 17 g in 1 PACKET", "package_ndc": "11523-7268-3", "marketing_start_date": "20070201"}, {"sample": false, "description": "765 g in 1 BOTTLE, PLASTIC (11523-7268-4)", "package_ndc": "11523-7268-4", "marketing_start_date": "20070201"}, {"sample": false, "description": "850 g in 1 BOTTLE, PLASTIC (11523-7268-5)", "package_ndc": "11523-7268-5", "marketing_start_date": "20250530"}, {"sample": false, "description": "24 PACKET in 1 CARTON (11523-7268-8)  / 17 g in 1 PACKET", "package_ndc": "11523-7268-8", "marketing_start_date": "20070201"}, {"sample": false, "description": "20 POUCH in 1 CARTON (11523-7268-9)  / 17 g in 1 POUCH", "package_ndc": "11523-7268-9", "marketing_start_date": "20070201"}], "brand_name": "MiraLAX", "product_id": "11523-7268_3ac22f1f-b34c-0c18-e063-6394a90a9742", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "11523-7268", "generic_name": "Polyethylene Glycol 3350", "labeler_name": "Bayer HealthCare 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": "20070201", "listing_expiration_date": "20261231"}