FDA.reportPublic FDA data

NDC 55154-5035-06 - 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
55154-5035
Requested NDC
55154-5035-06
Package NDCs from labels
55154-5035-6, 55154-5035-06
Manufacturer
Cardinal Health 107, LLC
Effective date
2025-11-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MiraLAX - Cardinal Health 107, LLCCardinal Health 107, LLC2025-11-07HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-5035-6MiraLAX6 in 1 BAGPOWDER, FOR SOLUTION617
55154-5035-6MiraLAX17 g in 1 PACKETPOWDER, FOR SOLUTION1717

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5035MIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CARDINAL HEALTH 107, LLC]16Current NDC, Legacy NDC, 2 package rows20250305_1771d3bf-954d-49ea-b260-3d356e5dcfa5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PMIRALAX (POLYETHYLENE GLYCOL 3350) POWDER [CARDINAL HEALTH]4
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PMIRALAX (POLYETHYLENE GLYCOL 3350) POWDER [CARDINAL HEALTH]4

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 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350American Health Packaging81374641-e54c-4b41-a3ad-49b19a0976662026-02-18WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350GLENMARK THERAPEUTICS INC., USA5aba6bb1-d25d-4901-8e9c-4cd4a3a064712026-01-27WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Good Sense Clear LaxPOLYETHYLENE GLYCOL 3350Preferred Pharmaceuticals Inc.935f05da-3637-4a9e-843e-1f2ced5d1a742026-01-23WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350YYBA Corp48488531-5d04-4af6-e063-6294a90afe4b2026-01-13WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
EasyLAXPOLYETHYLENE GLYCOL 3350VALU MERCHANDISERS COMPANY6597811b-6471-5afd-e053-2991aa0a07c22025-12-16WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350ANI Pharmaceuticals, Inc.1afff730-b2d3-4e01-8403-97f2ecef3a742025-12-10WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
GAVILAXPOLYETHYLENE GLYCOL 3350Lupin Pharmaceuticals,Inc.19672e23-1606-497e-a112-939af33af1952025-12-08WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
MiraLAX Orange FlavorPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.0a5b2121-928f-8f49-e063-6394a90a8aaf2025-12-04WarningsExact identifier
rxcui: 876193
rxcui: 876195
unii: G2M7P15E5P
WalgreensPOLYETHYLENE GLYCOL 3350WALGREEN COMPANY97489a02-db59-4529-a091-abc737e44a962025-12-01WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
MiraLAXPOLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC1771d3bf-954d-49ea-b260-3d356e5dcfa52025-11-07WarningsExact identifier
application number: NDA022015
ndc (package): 55154-5035-6
ndc (product): 55154-5035
ndc11 (package): 55154503506
rxcui: 876193
rxcui: 876195
spl id: a30d3776-09c8-41aa-9282-ba2486632e07
spl set id: 1771d3bf-954d-49ea-b260-3d356e5dcfa5
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350A-S Medication Solutions4f31a33e-1f60-4aa7-b1dc-a3c011c03a702025-10-29WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350 Powder for SolutionPOLYETHYLENE GLYCOL, UNSPECIFIEDVALLEY MEDICAL PRODUCTS, LLCae595e97-6d29-44f8-a647-fcd54fcda5b12025-10-27WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC2f5c975f-0d35-4f68-a27c-28af9a8987332025-10-23WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
MiraLAXPOLYETHYLENE GLYCOL 3350ASCLEMED USA INC.e652042f-3707-4bf6-831d-d806638b7d852025-10-14WarningsExact identifier
application number: NDA022015
rxcui: 876193
rxcui: 876195
unii: G2M7P15E5P
LaxativePOLYETHYLENE GLYCOL 3350Rite Aid Corporation457f5d2d-4595-482a-9ffa-659fb5d5b1342025-10-09WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Bryant Ranch Prepack5df518fb-ad58-4f17-af34-f66066f1313a2025-09-30WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
DulcolaxPOLYETHYLENE GLYCOL 3350Chattem, Inc.ed16d0f4-74e7-4fa3-989d-c6840a5d3e712025-09-30WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
kirkland signature laxaclear original prescription strengthPOLYETHYLENE GLYCOL 3350Costco Wholesale Companyf58fa5c0-8ab7-4427-aea0-d536b47acbb52025-09-18WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
up and up powderlaxPOLYETHYLENE GLYCOL 3350Target Corporation1bceb457-b24f-485d-bfe2-af4b7d38a5c22025-09-18WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

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