Polyethylene Glycol 3350, NF Powder for Solution, Laxative

Product NDC
79739-7116
11-digit product format
797397116
Labeler code
79739
Product ID
79739-7116_fc3454ec-7729-4327-90f7-9e12dddb19d6
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350, NF Powder for Solution, Laxative
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
LGM PHARMA SOLUTIONS, LLC
Application
ANDA090812
Marketing category
ANDA
Marketing start
2009-10-07
Substance
POLYETHYLENE GLYCOL 3350
Active strength
17 g/d
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 3350, NF Powder for Solution, LaxativePOLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVELGM PHARMA SOLUTIONS, LLCd78bead5-ff19-4d45-9003-ec131f1f5a132024-01-17WarningsExact 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 Manufactured by: LGM Pharma Solutions, LLC Irvine, CA 92614 7116-0 119 -99- EC -PD Rev. 01/2022 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, NF Powder for Solution, Laxative
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYETHYLENE GLYCOL 335017 g/d

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79739-7116-1Polyethylene Glycol 3350, NF Powder for Solution, Laxative7 d in 1 BOTTLEPOWDER, FOR SOLUTION74
79739-7116-2Polyethylene Glycol 3350, NF Powder for Solution, Laxative14 d in 1 BOTTLEPOWDER, FOR SOLUTION144
79739-7116-3Polyethylene Glycol 3350, NF Powder for Solution, Laxative30 d in 1 BOTTLEPOWDER, FOR SOLUTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79739-7116POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE POWDER, FOR SOLUTION [LGM PHARMA SOLUTIONS, LLC]4Current NDC, Legacy NDC, 3 package rows20240116_d78bead5-ff19-4d45-9003-ec131f1f5a13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNd78bead5-ff19-4d45-9003-ec131f1f5a134
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDd78bead5-ff19-4d45-9003-ec131f1f5a134
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYd78bead5-ff19-4d45-9003-ec131f1f5a134

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79739-7116-1797397116017 d in 1 BOTTLE (79739-7116-1) 7 d2009-10-070000-00-00NoNoCurrent
79739-7116-27973971160214 d in 1 BOTTLE (79739-7116-2) 14 d2009-10-070000-00-00NoNoCurrent
79739-7116-37973971160330 d in 1 BOTTLE (79739-7116-3) 30 d2009-10-070000-00-00NoNoCurrent