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 4 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
GAVILYTE G TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESLupin Pharmaceuticals,Inc.3978822b-6473-4072-9f80-20ceb9bea3552025-09-10Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350 and electrolytes - UnflavoredPOLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVOREDStrides Pharma Science Limited48c741a9-9039-4fdb-a875-86d4ea9682822025-09-05Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - UnflavoredPOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVOREDStrides Pharma Science Limited37c111ec-5b62-42b9-bbb2-3b0c530e34c92025-09-01Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
clearlaxPOLYETHYLENE GLYCOL 3350Meijer, Inc.8cca18a8-94f6-43f6-bdb7-2d44a6cdf1512025-08-08WarningsExact identifier
application number: ANDA090685
rxcui: 876193
unii: G2M7P15E5P
GAVILAXPOLYETHYLENE GLYCOL 3350ATLANTIC BIOLOGICALS CORP.c9688f06-b6db-4afb-b8ff-ef5fb8bf99462025-07-22WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Kesin Pharma Corporation3729a1d2-4c98-dfdf-e063-6394a90a5a872025-06-12WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
CLEARLAXPOLYETHYLENE GLYCOL 3350STRATEGIC SOURCING SERVICES LLC041157b8-476c-e7d2-e063-6394a90ac3a02025-06-11WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Camber Consumer Care Incb321a7f5-f80b-4a51-9fd9-2c21fc1cae9b2025-04-23WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
good neighbor pharmacy clearlaxPOLYETHYLENE GLYCOL 3350Amerisource Bergene0b419b6-6ce0-4aaa-948f-dee5b2ec20822025-04-17WarningsExact identifier
application number: ANDA090685
rxcui: 876193
unii: G2M7P15E5P
WincoPOLYETHYLENE GLYCOL 3350WINCO FOODSd649f758-a46f-4864-8718-878ee5a74bfc2025-04-10WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Gycol 3350POLYETHYLENE GYCOL 3350Allegiant Health13851c9a-a226-481b-9db5-bc7053997df72025-03-17WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Aspartame/MSG DetoxCHELIDONIUM MAJUS, ARNICA MONTANA, PHYTOLACCA DECANDRA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BISPHENOL A (BPA), DEXTROSE, MALTODEXTRIN, SUCRALOSE, ASPARTIC ACID, DIKETOPIPERAZINE, DOPAMINE HYDROCHLORIDE, FORMALINUM, FORMICUM ACIDUM, L-PHENYLALANINE, METHYL ALCOHOL, MONOSODIUM GLUTAMATEDeseret Biologicals, Inc.a1dc1bf3-db71-4550-a975-4f146fb940052025-03-11WarningsExact identifier
unii: 96K6UQ3ZD4
Polyethylene Glycol 3350, NF Powder for Solution, LaxativePOLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVEPharmaceutica North America, Inc.d048111f-8144-4d51-a0c2-a967b2bce4552025-03-04WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350NorthStar Rx LLC2e7e72eb-b759-5b59-e063-6394a90aa7ff2025-02-19WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
GAVILAXPOLYETHYLENE GLYCOL 3350A-S Medication Solutions581baa4b-7331-47a3-81c6-680286f03aca2025-01-09WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Leader ClearLaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader9b759bd9-3818-4b71-a99c-aa7e202bf22e2024-10-01WarningsExact identifier
application number: ANDA090685
rxcui: 876193
unii: G2M7P15E5P
rugby PEG 3350POLYETHYLENE GLYCOL 3350Bryant Ranch Prepackfb3f889c-7f88-4850-9994-d436f90109902024-09-06WarningsExact identifier
application number: ANDA090685
rxcui: 876193
unii: G2M7P15E5P
Members Mark clearlaxPOLYETHYLENE GLYCOL 3350Sam's West Inc5bc34a90-adc2-4031-b8a6-7258298815502024-09-05WarningsExact identifier
application number: ANDA090685
rxcui: 876193
unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

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