POLYETHYLENE GLYCOL 3350

Product NDC
57896-489
11-digit product format
578960489
Labeler code
57896
Product ID
57896-489_ee3ad47b-8219-3bc4-e053-2a95a90af736
Type
HUMAN OTC DRUG
Nonproprietary name
polyethylene glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Geri-Care Pharmaceutical Corp
Application
ANDA090812
Marketing category
ANDA
Marketing start
2014-05-01
Substance
POLYETHYLENE GLYCOL 3350
Active strength
17 g/17g
Pharmacologic classes
Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090812-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350Geri-Care Pharmaceutical Corpf4c7eb80-d8d5-406d-90d0-9d17914d71f22022-11-24WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Allergy alert: Do not use if you are allergic to polyethylene glycol Do not use if you have kidney disease, except under the advice and supervision of a doctor Ask a doctor before use if you have nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks irritable bowel syndrome Ask a doctor or pharmacist before use if you are taking a prescription drug When using this product you may have loose, watery, more frequent stools Stop use and ask a doctor if you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition. you get diarrhea you need to use a laxative for longer than 1 week If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
POLYETHYLENE GLYCOL 3350
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYETHYLENE GLYCOL 335017 g/17g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2M7P15E5P
Rxcui876193

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57896-489-142020-12-22C16284748780-19d75b9d1-1edb-f424-e053-dadaa90a57cegc peg 489
57896-489-302020-12-22C16284748780-19d75b9d1-1edb-f424-e053-dadaa90a57cegc peg 489
57896-489-142020-01-31C16284748780-19d75b9d1-1edb-f424-e053-dadaa90a57cegc peg 489
57896-489-302020-01-31C16284748780-19d75b9d1-1edb-f424-e053-dadaa90a57cegc peg 489

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-489-14POLYETHYLENE GLYCOL 3350238 g in 1 BOTTLEPOWDER, FOR SOLUTION2385
57896-489-30POLYETHYLENE GLYCOL 3350510 g in 1 BOTTLEPOWDER, FOR SOLUTION5105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-489-14GM - Gram57896-48911727b7b-d1a3-4e22-8351-feb7b914446112013-03-03
57896-489-30GM - Gram57896-489a2e5e091-af1d-45aa-8b51-91e858afac4212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PPOLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [GERI-CARE PHARMACEUTICAL CORP]1
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PPOLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [GERI-CARE PHARMACEUTICAL CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-489POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [GERI-CARE PHARMACEUTICAL CORP]5Current NDC, Legacy NDC, 2 package rows20221125_f4c7eb80-d8d5-406d-90d0-9d17914d71f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN66276671-0ccd-4c32-a697-31e679fce0e3102
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD66276671-0ccd-4c32-a697-31e679fce0e3102
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY66276671-0ccd-4c32-a697-31e679fce0e3102
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNf4c7eb80-d8d5-406d-90d0-9d17914d71f25
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDf4c7eb80-d8d5-406d-90d0-9d17914d71f25
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYf4c7eb80-d8d5-406d-90d0-9d17914d71f25
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNb4a571c7-230a-4955-875e-112cbe1f55961
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDb4a571c7-230a-4955-875e-112cbe1f55961
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYb4a571c7-230a-4955-875e-112cbe1f55961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-489-1457896048914238 g in 1 BOTTLE (57896-489-14) 238 g2016-07-010000-00-00NoNoCurrent
57896-489-3057896048930510 g in 1 BOTTLE (57896-489-30) 510 g2016-07-010000-00-00NoNoCurrent