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 4 of 5 · 93 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350NorthStar Rx LLC2e7e72eb-b759-5b59-e063-6394a90aa7ff2025-02-19WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
GAVILAXPOLYETHYLENE GLYCOL 3350A-S Medication Solutions581baa4b-7331-47a3-81c6-680286f03aca2025-01-09WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
clear laxPOLYETHYLENE GLYCOL 3350H E Bbd16827b-5e6a-4fa7-bc2e-c9a05e1e2dab2024-12-02WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Leader ClearLaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader9b759bd9-3818-4b71-a99c-aa7e202bf22e2024-10-01WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
rugby PEG 3350POLYETHYLENE GLYCOL 3350Bryant Ranch Prepackfb3f889c-7f88-4850-9994-d436f90109902024-09-06WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Members Mark clearlaxPOLYETHYLENE GLYCOL 3350Sam's West Inc5bc34a90-adc2-4031-b8a6-7258298815502024-09-05WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
GENTLELAXPOLYETHYLENE GLYCOL 3350Kroger Company2390b507-93d5-43a0-aa51-31ca4edd6b7f2024-07-03WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
careone clearlaxPOLYETHYLENE GLYCOL 3350Retail Business Services, LLC2378b76d-dc5a-4ff1-ad48-9f3e0c31c6cd2024-05-19WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350CHAIN DRUG MARKETING ASSOCIATION, INC.901a1918-87bb-47c2-a465-8c468c3a1ee52024-03-26WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
smoothlaxPOLYETHYLENE GLYCOL 3350Walgreen Companyaeb5c32c-443e-4ea3-8e96-fed38225fdf32024-03-12WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Topcare ClearLaxPOLYETHYLENE GLYCOL 3350Topco Associates LLC02f81a86-bec5-4e8b-bddb-d463ae2ea9e92024-02-07WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350Bryant Ranch Prepack66276671-0ccd-4c32-a697-31e679fce0e32024-02-06WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350BluePoint Laboratories02e36812-53c2-003b-e063-6394a90aed122024-01-31WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Welby ClearLaxPOLYETHYLENE GLYCOL 3350Aldi, Incd64caba5-614f-4edc-bb47-ce4fed38ce452023-11-10WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
equaline clearlaxPOLYETHYLENE GLYCOL 3350United Natural Foods, Inc. dba UNFIe0871542-9136-4cf8-a4b7-6c2b6edcbe0e2023-08-07WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
good sense clearlaxPOLYETHYLENE GLYCOL 3350L. Perrigo Company9858edef-cdb2-4ac4-8e4b-ba0720a24e412023-06-01WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
berkley and jensen clearlaxPOLYETHYLENE GLYCOL 3350BJWCf9eb9023-c83b-49b4-af82-d8344ffa46c32023-05-12WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
dg health clearlaxPOLYETHYLENE GLYCOL 3350Dolgencorp Incffae36fd-2fb7-4afb-a7f8-29c700a477fb2023-05-04WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
clearlaxPOLYETHYLENE GLYCOL 3350Publix Super Markets Incee30489a-8683-4403-8f85-76434242663c2023-02-15WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Good Neighbor Pharmacy ClearLaxPOLYETHYLENE GLYCOL 3350Amerisource Bergen4f2d3ef2-5097-4653-8dab-de5ba1fb9c412023-02-15WarningsName 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