FDA.reportPublic FDA data

Application 020698

Type
NDA
Sponsor
BRAINTREE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIRALAXPOLYETHYLENE GLYCOL 3350FOR SOLUTION; ORAL17GM/SCOOPFULNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 5 · 93 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MiraLAX Orange FlavorPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.0a5b2121-928f-8f49-e063-6394a90a8aaf2025-12-04WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
WalgreensPOLYETHYLENE GLYCOL 3350WALGREEN COMPANY97489a02-db59-4529-a091-abc737e44a962025-12-01WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
MiraLAXPOLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC1771d3bf-954d-49ea-b260-3d356e5dcfa52025-11-07WarningsName fallback
brand name: MiraLAX
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350A-S Medication Solutions4f31a33e-1f60-4aa7-b1dc-a3c011c03a702025-10-29WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLCe26457c4-03e8-430e-bfad-38ae105dbf6f2025-10-23WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC2f5c975f-0d35-4f68-a27c-28af9a8987332025-10-23WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
MiraLAXPOLYETHYLENE GLYCOL 3350ASCLEMED USA INC.e652042f-3707-4bf6-831d-d806638b7d852025-10-14WarningsName fallback
brand name: MiraLAX
generic name: POLYETHYLENE GLYCOL 3350
LaxativePOLYETHYLENE GLYCOL 3350Rite Aid Corporation457f5d2d-4595-482a-9ffa-659fb5d5b1342025-10-09WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Bryant Ranch Prepack5df518fb-ad58-4f17-af34-f66066f1313a2025-09-30WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
DulcolaxPOLYETHYLENE GLYCOL 3350Chattem, Inc.ed16d0f4-74e7-4fa3-989d-c6840a5d3e712025-09-30WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
kirkland signature laxaclear original prescription strengthPOLYETHYLENE GLYCOL 3350Costco Wholesale Companyf58fa5c0-8ab7-4427-aea0-d536b47acbb52025-09-18WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
up and up powderlaxPOLYETHYLENE GLYCOL 3350Target Corporation1bceb457-b24f-485d-bfe2-af4b7d38a5c22025-09-18WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
clearlaxPOLYETHYLENE GLYCOL 3350Meijer, Inc.8cca18a8-94f6-43f6-bdb7-2d44a6cdf1512025-08-08WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
GAVILAXPOLYETHYLENE GLYCOL 3350ATLANTIC BIOLOGICALS CORP.c9688f06-b6db-4afb-b8ff-ef5fb8bf99462025-07-22WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Kesin Pharma Corporation3729a1d2-4c98-dfdf-e063-6394a90a5a872025-06-12WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
CLEARLAXPOLYETHYLENE GLYCOL 3350STRATEGIC SOURCING SERVICES LLC041157b8-476c-e7d2-e063-6394a90ac3a02025-06-11WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350SKY Packaging173a62cb-9b20-4b50-e063-6294a90ac36b2025-05-14WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Camber Consumer Care Incb321a7f5-f80b-4a51-9fd9-2c21fc1cae9b2025-04-23WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
good neighbor pharmacy clearlaxPOLYETHYLENE GLYCOL 3350Amerisource Bergene0b419b6-6ce0-4aaa-948f-dee5b2ec20822025-04-17WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
WincoPOLYETHYLENE GLYCOL 3350WINCO FOODSd649f758-a46f-4864-8718-878ee5a74bfc2025-04-10WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
25533SUPPL2004-08-10
25532SUPPL2004-06-09
20831ORIG1999-08-17
35152ORIG1999-02-18
25531ORIG1999-02-18