FDA.reportPublic FDA data

NDC 11523-0122-01 - MiraLAX Orange Flavor

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
11523-0122
Requested NDC
11523-0122-01
Package NDCs from labels
11523-0122-2, 11523-0122-1, 11523-0122-01
Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MiraLAX ® Orange FlavorBayer HealthCare LLC.2025-12-04HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0122-1MiraLAX Orange Flavor238 g in 1 BOTTLEPOWDER, FOR SOLUTION2383
11523-0122-2MiraLAX Orange Flavor119 g in 1 BOTTLEPOWDER, FOR SOLUTION1193

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0122MIRALAX ORANGE FLAVOR (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.]2Current NDC, 2 package rows20241208_0a5b2121-928f-8f49-e063-6394a90a8aaf.zip

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 · 107 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
application number: ANDA090685
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350YYBA Corp48488531-5d04-4af6-e063-6294a90afe4b2026-01-13WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Artificial Sweetener Detox 6034ARTIFICIAL SWEETENER DETOXProfessional Complementary Health Formulas38f2ae0b-2b1f-4b49-934d-fe1556f84d932026-01-08WarningsExact identifier
unii: 96K6UQ3ZD4
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
application number: ANDA090685
ndc (package): 11523-0122-1
ndc (package): 11523-0122-2
ndc (product): 11523-0122
ndc11 (package): 11523012201
rxcui: 876193
rxcui: 876195
spl id: 4526ca58-f032-31ad-e063-6394a90a7bae
spl set id: 0a5b2121-928f-8f49-e063-6394a90a8aaf
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
rxcui: 876193
rxcui: 876195
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350A-S Medication Solutions4f31a33e-1f60-4aa7-b1dc-a3c011c03a702025-10-29WarningsExact identifier
application number: ANDA090685
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
rxcui: 876193
rxcui: 876195
unii: G2M7P15E5P
LaxativePOLYETHYLENE GLYCOL 3350Rite Aid Corporation457f5d2d-4595-482a-9ffa-659fb5d5b1342025-10-09WarningsExact identifier
application number: ANDA090685
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Bryant Ranch Prepack5df518fb-ad58-4f17-af34-f66066f1313a2025-09-30WarningsExact identifier
application number: ANDA090685
rxcui: 876193
unii: G2M7P15E5P
DulcolaxPOLYETHYLENE GLYCOL 3350Chattem, Inc.ed16d0f4-74e7-4fa3-989d-c6840a5d3e712025-09-30WarningsExact identifier
application number: ANDA090685
rxcui: 876193
unii: G2M7P15E5P
kirkland signature laxaclear original prescription strengthPOLYETHYLENE GLYCOL 3350Costco Wholesale Companyf58fa5c0-8ab7-4427-aea0-d536b47acbb52025-09-18WarningsExact identifier
application number: ANDA090685
rxcui: 876193
unii: G2M7P15E5P
up and up powderlaxPOLYETHYLENE GLYCOL 3350Target Corporation1bceb457-b24f-485d-bfe2-af4b7d38a5c22025-09-18WarningsExact identifier
application number: ANDA090685
rxcui: 876193
unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

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