FDA.reportPublic FDA data

Laxative

Product NDC
11822-0306
11-digit product format
118220306
Labeler code
11822
Product ID
11822-0306_8ab5ee18-0cf9-4ae5-9ba5-46c8fcc5d3d3
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA090685
Marketing category
ANDA
Marketing start
2009-10-09
Marketing end
2027-12-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Laxative

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0306-0Laxative17 g in 1 PACKETPOWDER, FOR SOLUTION1713
11822-0306-1Laxative765 g in 1 BOTTLEPOWDER, FOR SOLUTION76513
11822-0306-3Laxative119 g in 1 BOTTLEPOWDER, FOR SOLUTION11913
11822-0306-4Laxative238 g in 1 BOTTLEPOWDER, FOR SOLUTION23813
11822-0306-5Laxative510 g in 1 BOTTLEPOWDER, FOR SOLUTION51013
11822-0306-6Laxative289 g in 1 BOTTLEPOWDER, FOR SOLUTION28913
11822-0306-7Laxative850 g in 1 BOTTLEPOWDER, FOR SOLUTION85013
11822-0306-8Laxative595 g in 1 BOTTLEPOWDER, FOR SOLUTION59513
11822-0306-9Laxative10 in 1 CARTONPOWDER, FOR SOLUTION1013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PLAXATIVE (POLYETHYLENE GLYCOL 3350) POWDER [RITE AID CORPORATION]5
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PLAXATIVE (POLYETHYLENE GLYCOL 3350) POWDER [RITE AID CORPORATION]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0306LAXATIVE (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [RITE AID CORPORATION]12Current NDC, Legacy NDC, 9 package rows20240305_457f5d2d-4595-482a-9ffa-659fb5d5b134.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN457f5d2d-4595-482a-9ffa-659fb5d5b13413
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD457f5d2d-4595-482a-9ffa-659fb5d5b13413
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY457f5d2d-4595-482a-9ffa-659fb5d5b13413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0306-01182203060017 g in 1 PACKET17 gHistorical
11822-0306-111822030601765 g in 1 BOTTLE (11822-0306-1) 765 g2023-02-232027-11-30NoNoHistorical
11822-0306-311822030603119 g in 1 BOTTLE (11822-0306-3) 119 g2009-10-092027-12-31NoNoCurrent
11822-0306-411822030604238 g in 1 BOTTLE (11822-0306-4) 238 g2009-10-092027-12-31NoNoCurrent
11822-0306-511822030605510 g in 1 BOTTLE (11822-0306-5) 510 g2012-02-052027-10-31NoNoCurrent
11822-0306-611822030606289 g in 1 BOTTLE (11822-0306-6) 289 g2014-08-060000-00-00NoNoCurrent
11822-0306-711822030607850 g in 1 BOTTLE (11822-0306-7) 850 g2013-12-050000-00-00NoNoCurrent
11822-0306-811822030608595 g in 1 BOTTLE (11822-0306-8) 595 g2014-08-060000-00-00NoNoCurrent
11822-0306-91182203060910 PACKET in 1 CARTON (11822-0306-9) / 17 g in 1 PACKET (11822-0306-0) 10 packet2009-10-092026-08-01NoNoCurrent