FDA.reportPublic FDA data

NDC 11523-4357-05 - MiraLAX

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
11523-4357
Requested NDC
11523-4357-05
Package NDCs from labels
11523-4357-1, 11523-4357-3, 11523-4357-5, 11523-4357-2, 11523-4357-05
Manufacturer
Bayer HealthCare LLC.
Effective date
2026-05-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MiraLAX ®Bayer HealthCare LLC.2026-05-04HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4357-1MiraLAX2 in 1 PACKAGE, COMBINATIONPOWDER, FOR SOLUTION224
11523-4357-1MiraLAX765 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION76524
11523-4357-2MiraLAX20 in 1 CARTONPOWDER, FOR SOLUTION2024
11523-4357-2MiraLAX2 in 1 CARTONPOWDER, FOR SOLUTION224
11523-4357-3MiraLAX2 in 1 PACKAGE, COMBINATIONPOWDER, FOR SOLUTION224
11523-4357-3MiraLAX578 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION57824
11523-4357-5MiraLAX17 g in 1 PACKETPOWDER, FOR SOLUTION1724
11523-4357-5MiraLAX24 in 1 CARTONPOWDER, FOR SOLUTION2424

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4357MIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.]22Current NDC, Legacy NDC, 8 package rows20241208_d69ce3d4-7ca4-4fe3-b49e-6655e48d6963.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4357-3GM - Gram11523-4357c98dcd88-dfc7-488c-b201-0728a80162fa12025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Polyethylene Glycol 3350ACTIVE INGREDIENTG2M7P15E5PMIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [MSD CONSUMER CARE, INC.]9
Polyethylene Glycol 3350ACTIVE MOIETYG2M7P15E5PMIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [MSD CONSUMER CARE, INC.]9

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 5 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350CHAIN DRUG MARKETING ASSOCIATION, INC.901a1918-87bb-47c2-a465-8c468c3a1ee52024-03-26WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
smoothlaxPOLYETHYLENE GLYCOL 3350Walgreen Companyaeb5c32c-443e-4ea3-8e96-fed38225fdf32024-03-12WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Topcare ClearLaxPOLYETHYLENE GLYCOL 3350Topco Associates LLC02f81a86-bec5-4e8b-bddb-d463ae2ea9e92024-02-07WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350Bryant Ranch Prepack66276671-0ccd-4c32-a697-31e679fce0e32024-02-06WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350BluePoint Laboratories02e36812-53c2-003b-e063-6394a90aed122024-01-31WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350, NF Powder for Solution, LaxativePOLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVELGM PHARMA SOLUTIONS, LLCd78bead5-ff19-4d45-9003-ec131f1f5a132024-01-17WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Welby ClearLaxPOLYETHYLENE GLYCOL 3350Aldi, Incd64caba5-614f-4edc-bb47-ce4fed38ce452023-11-10WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
PEG-3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions7a2d8dab-750f-43c1-933c-4169a840c60c2023-06-20Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
good sense clearlaxPOLYETHYLENE GLYCOL 3350L. Perrigo Company9858edef-cdb2-4ac4-8e4b-ba0720a24e412023-06-01WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
dg health clearlaxPOLYETHYLENE GLYCOL 3350Dolgencorp Incffae36fd-2fb7-4afb-a7f8-29c700a477fb2023-05-04WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
laxativePOLYETHYLENE GLYCOL 3350Rite Aid Corporation3ebe9191-8e0a-41cf-b759-82ecce4f50e42023-02-10WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESNovel Laboratories, Inc.29d821ff-389c-41fb-8a27-89bd3f022b822023-02-08Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
dg health clearlaxPOLYETHYLENE GLYCOL 3350Dolgencorp, LLC94280ce4-b2cf-451d-a660-b26ab1a2d3f02023-02-06WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
clearlaxPOLYETHYLENE GLYCOL 3350H E B0b4b752d-045d-4ff0-8e50-5607d1a841a72023-01-26WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Good Sense Clear LaxPOLYETHYLENE GLYCOL 3350L. Perrigo Company435db89c-1e32-4da5-b7d0-15e4071627152023-01-24WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
basic care clearlaxPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC21897170-0d5e-4326-bebf-10258e0aca822022-12-08WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350Geri-Care Pharmaceutical Corpf4c7eb80-d8d5-406d-90d0-9d17914d71f22022-11-24WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Gericare Pharmaceuticals5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd2022-10-28WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Equate ClearLAXPOLYETHYLENE GLYCOL 3350WALMART INC.c5c13378-3c08-415f-8ab4-8a18d6300ca82022-09-08WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
injoy constipation reliefPOLYETHYLENE GLYCOL 3350L. Perrigo Companyb2414517-04bf-4f29-951e-b867855078c32022-08-19WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

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