Application 022015

Type
NDA
Sponsor
BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIRALAXPOLYETHYLENE GLYCOL 3350FOR SOLUTION;ORAL17GM/SCOOPFULYesYes
002MIRALAXPOLYETHYLENE GLYCOL 3350FOR SOLUTION;ORAL17GM/PACKETYesYes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022015-001MIRALAXPOLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06
N022015-002MIRALAXPOLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORALRLD, RS2006-10-06

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MiraLAXPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.d69ce3d4-7ca4-4fe3-b49e-6655e48d69632026-05-04WarningsExact identifier
MiraLAXPOLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC1771d3bf-954d-49ea-b260-3d356e5dcfa52025-11-07WarningsExact identifier
MiraLAXPOLYETHYLENE GLYCOL 3350ASCLEMED USA INC.e652042f-3707-4bf6-831d-d806638b7d852025-10-14WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Allergy alert Do not use if you are allergic to polyethylene glycol Do not use if you have kidney disease, except under the advice and supervision of a doctor Ask a doctor before use if you have nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks irritable bowel syndrome Ask a doctor of pharmacist before use if you are taking a prescription drug When using this product you may have loose, watery, more frequent stools Stop use and ask a doctor if you have rectal bleeding or you nausea, bloating or cramping or abdominal pain gets worse. These may be signs of a serious condition. you get diarrhea you need to use a laxative for longer than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11523-4357MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-4357MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-4357MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-4357MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-4357MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7234MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7234MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7234MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7234MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7234MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7268MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7268MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7268MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7268MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7268MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7341MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7341MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7341MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7341MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
11523-7341MiraLAXPolyethylene Glycol 3350Bayer HealthCare LLC.NDACurrent
30142-526KrogerPolyethylene Glycol 3350KROGER COMPANYNDACurrent
55154-5035MiraLAXPolyethylene Glycol 3350Cardinal Health 107, LLCNDACurrent
55154-5035MiraLAXPolyethylene Glycol 3350Cardinal HealthNDACurrent
55154-5035MiraLAXPolyethylene Glycol 3350Cardinal HealthNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83609SUPPL 2025-09-30
81175SUPPL 2025-02-07
76015SUPPL 2023-10-31
75514SUPPL 2023-09-19
74943SUPPL 2023-07-31
74916SUPPL 2023-07-28
74569SUPPL 2023-06-21
74568SUPPL 2023-06-21
73853SUPPL 2023-03-24
73852SUPPL 2023-03-24
71521SUPPL2022-07-06
71723SUPPL2022-07-05
67488SUPPL2021-05-14
67195SUPPL2021-04-28
58981SUPPL2019-06-05
58980SUPPL2019-06-05
55961SUPPL2018-10-17
55931SUPPL2018-10-15
55331SUPPL2018-08-27
55220SUPPL2018-08-20
54053SUPPL2018-05-08
54045SUPPL2018-05-08
54005SUPPL2018-05-03
53864SUPPL2018-04-27
50096SUPPL2017-10-18
49973SUPPL2017-10-06
45643SUPPL2016-10-27
45637SUPPL2016-10-25
45586SUPPL2016-10-11
45476SUPPL2016-10-05
16774SUPPL2015-11-19
6692SUPPL2015-11-16
29086SUPPL2015-11-04
16773SUPPL2015-11-04
29085SUPPL2014-08-06
38088SUPPL2014-08-04
6691SUPPL2012-03-19
6690SUPPL2010-05-07
6689SUPPL2008-12-04
29084SUPPL2008-11-21
21908ORIG2007-06-22
29083ORIG2006-10-13