FDA.reportPublic FDA data

NDC 57896-490-01 - Polyethylene Glycol 3350

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
57896-490
Requested NDC
57896-490-01
Package NDCs from labels
57896-490-07, 57896-490-14, 57896-490-30, 57896-490-45, 57896-490-01, 57896-490-03
Manufacturer
Gericare Pharmaceuticals
Effective date
2022-10-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Polyethylene Glycol 3350 - Gericare PharmaceuticalsGericare Pharmaceuticals2022-10-28HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-490-01Polyethylene Glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION175
57896-490-03Polyethylene Glycol 335030 in 1 CARTONPOWDER, FOR SOLUTION305
57896-490-07Polyethylene Glycol 3350119 g in 1 CANPOWDER, FOR SOLUTION1195
57896-490-14Polyethylene Glycol 3350238 g in 1 CANPOWDER, FOR SOLUTION2385
57896-490-30Polyethylene Glycol 3350510 g in 1 CANPOWDER, FOR SOLUTION5105
57896-490-45Polyethylene Glycol 3350765 g in 1 CANPOWDER, FOR SOLUTION7655

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-490POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [GERICARE PHARMACEUTICALS]5Current NDC, Legacy NDC, 6 package rows20221029_5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-490-01EA - Each57896-490ede5bbcf-1589-40bf-a1b7-fe5092aaf06412023-06-06
57896-490-03EA - Each57896-490fa65e357-a4c0-4189-8032-3c4329957a5312023-06-06

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
application number: ANDA203928
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350GLENMARK THERAPEUTICS INC., USA5aba6bb1-d25d-4901-8e9c-4cd4a3a064712026-01-27WarningsExact identifier
application number: ANDA203928
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
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
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
application number: ANDA203928
rxcui: 876193
unii: G2M7P15E5P
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC2f5c975f-0d35-4f68-a27c-28af9a8987332025-10-23WarningsExact identifier
application number: ANDA203928
rxcui: 876193
unii: G2M7P15E5P
MiraLAXPOLYETHYLENE GLYCOL 3350ASCLEMED USA INC.e652042f-3707-4bf6-831d-d806638b7d852025-10-14WarningsExact identifier
rxcui: 876193
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.