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 2 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
365 WHOLE FOODS MARKET Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Whole Foods Market, Inc.b19f42a9-18ac-4d23-87b5-3c43e47c40542026-06-05WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
GAVILAXPOLYETHYLENE GLYCOL 3350Atlantic Biologicals Corp.4c207478-6f0f-c3cf-e063-6394a90aa4f22026-06-04WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticalsddc9d2b1-87d8-44fa-bac6-0a7261f335642026-05-12WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
smooth laxPOLYETHYLENE GLYCOL 3350Walgreen Company3027af65-2f7f-472d-83f5-254d5d75013c2026-05-08WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
MiraLAXPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.d69ce3d4-7ca4-4fe3-b49e-6655e48d69632026-05-04WarningsExact identifier
application number: NDA022015
ndc (package): 11523-7268-8
ndc (package): 11523-7234-2
ndc (package): 11523-4357-3
ndc (package): 11523-7268-4
ndc (package): 11523-4357-2
ndc (package): 11523-7234-9
ndc (package): 11523-7234-4
ndc (package): 11523-7268-9
ndc (package): 11523-7268-7
ndc (package): 11523-4357-1
ndc (package): 11523-7234-1
ndc (package): 11523-7234-3
ndc (package): 11523-7268-3
ndc (package): 11523-7234-5
ndc (package): 11523-7341-1
ndc (package): 11523-7234-6
ndc (package): 11523-7341-2
ndc (package): 11523-4357-5
ndc (package): 11523-7268-5
ndc (product): 11523-4357
ndc (product): 11523-7341
ndc (product): 11523-7268
ndc (product): 11523-7234
ndc11 (package): 11523435705
rxcui: 876193
rxcui: 876195
spl id: 51040c1b-71bf-bb83-e063-6294a90aca4e
spl set id: d69ce3d4-7ca4-4fe3-b49e-6655e48d6963
unii: G2M7P15E5P
GAVILAXPOLYETHYLENE GLYCOL 3350Preferred Pharmaceuticals, Inc.21654def-5ae0-422d-961b-1fe2456af00a2026-05-04WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350CARDINAL HEALTH 110, LLC. DBA LEADER04cc4f2e-1725-4710-8cfb-73a6bdf52e4f2026-04-23WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Aurobindo Pharma Limitedb51f2223-8266-4d6c-bf32-58e53e73b54d2026-04-23WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
COMFORTLAXPOLYETHYLENE GLYCOL 3350Family Dollar Stores, LLC02a44a41-0039-f6ec-e063-6394a90ae6f12026-04-23WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Aurohealth LLCd3c77f3f-57aa-4e2d-88aa-731cbb22af702026-04-23WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.b251752d-7750-482a-9364-0acf4ad47cc82026-04-16Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
GoLYTELYPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.7609ecf7-0ce0-4fbb-9c27-30987f6895752026-04-15Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridePOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.4e442a72-b13b-4869-8a1d-59356095b0912026-04-14Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
clear laxPOLYETHYLENE GLYCOL 3350Meijer Distribution Inc6464f12c-0883-46c5-943b-a84fe235588e2026-04-13WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol (3350)POLYETHYLENE GLYCOL (3350)Mylan Institutional Inc.219bcbc4-b84a-4209-9f34-ef2b0ef0d2732026-04-08WarningsExact identifier
rxcui: 876193
equate clear laxPOLYETHYLENE GLYCOL 3350Wal-Mart Stores Inc56a507f3-0cd1-4f02-9dfd-de297ba4bc1f2026-03-27WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
foster and thrive clearlaxPOLYETHYLENE GLYCOL 3350Strategic Sourcing Services LLC684e35cc-5a4f-458d-b5e7-e1933fea11392026-03-07WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
ez2go Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Valley Medical Products, LLCd64517d6-b0cc-4ba2-b260-e52faa8d4e782026-02-20WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Topcare ClearLaxPOLYETHYLENE GLYCOL 3350Topco Associates LLC03291fd3-7b64-4b79-ad84-e1b9b30a6b032026-02-19WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

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