MiraLAX
MiraLAX
Approved
Approval ID
1771d3bf-954d-49ea-b260-3d356e5dcfa5
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Feb 28, 2025
Manufacturers
FDA
Cardinal Health 107, LLC
DUNS: 118546603
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Polyethylene Glycol 3350
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55154-5035
Application NumberNDA022015
Product Classification
M
Marketing Category
C73594
G
Generic Name
Polyethylene Glycol 3350
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2025
FDA Product Classification
INGREDIENTS (1)
POLYETHYLENE GLYCOL 3350Active
Quantity: 17 g in 17 g
Code: G2M7P15E5P
Classification: ACTIB