FDA.reportPublic FDA data

purelax

Product NDC
59779-306
11-digit product format
597790306
Labeler code
59779
Product ID
59779-306_058dfc70-1941-42dc-af01-f382a60d8f77
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA090685
Marketing category
ANDA
Marketing start
2009-10-07
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

Additional Listing Data#

Finished product
Yes
Brand name base
purelax
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2M7P15E5P
Rxcui876193, 1010732

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
59779-306-01purelax119 g in 1 BOTTLEPOWDER, FOR SOLUTION11915
59779-306-02purelax238 g in 1 BOTTLEPOWDER, FOR SOLUTION23815
59779-306-03purelax510 g in 1 BOTTLEPOWDER, FOR SOLUTION51015
59779-306-04purelax850 g in 1 BOTTLEPOWDER, FOR SOLUTION85015
59779-306-09purelax765 g in 1 BOTTLEPOWDER, FOR SOLUTION76515
59779-306-17purelax289 g in 1 BOTTLEPOWDER, FOR SOLUTION28915
59779-306-18purelax153 g in 1 BOTTLEPOWDER, FOR SOLUTION15315
59779-306-19purelax595 g in 1 BOTTLEPOWDER, FOR SOLUTION59515
59779-306-52purelax10 in 1 CARTONPOWDER, FOR SOLUTION1015
59779-306-52purelax17 g in 1 POUCHPOWDER, FOR SOLUTION1715
59779-306-53purelax17 g in 1 POUCHPOWDER, FOR SOLUTION1715
59779-306-53purelax12 in 1 CARTONPOWDER, FOR SOLUTION1215
59779-306-60purelax17 g in 1 POUCHPOWDER, FOR SOLUTION1715
59779-306-60purelax20 in 1 CARTONPOWDER, FOR SOLUTION2015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-306-01GM - Gram59779-306fc5bb141-c7e7-4fc8-bb56-8a92a8bc5a3712018-07-03
59779-306-02GM - Gram59779-3069d62492f-fac6-4f22-9205-63753e80a65e12018-08-13
59779-306-03GM - Gram59779-306c69d63ed-a966-42d6-bf0f-23a6838d09d912018-07-03
59779-306-04GM - Gram59779-306b286bf6a-d519-491f-bd5f-4555e092145512018-09-05
59779-306-52EA - Each59779-30658855e39-45ce-462b-8c45-412b93caae6112022-06-06
59779-306-53EA - Each59779-3066c9d46cb-8a47-47b8-8df0-b6ea2190883b12022-06-06
59779-306-60EA - Each59779-3060fe1603c-6a0d-472c-84f1-1258a9c2b45612024-09-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PPURELAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CVS PHARMACY]6
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PPURELAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CVS PHARMACY]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-306PURELAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CVS PHARMACY]15Current NDC, Legacy NDC, 14 package rows20250323_006a9eca-400f-47f5-bee5-facf7034043e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN006a9eca-400f-47f5-bee5-facf7034043e15
1010732Purelax 17 GM Powder for Oral SolutionPSN006a9eca-400f-47f5-bee5-facf7034043e15
1010732polyethylene glycol 3350 17000 MG Powder for Oral Solution [PureLax]SBD006a9eca-400f-47f5-bee5-facf7034043e15
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD006a9eca-400f-47f5-bee5-facf7034043e15
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY006a9eca-400f-47f5-bee5-facf7034043e15
1010732PureLax 17 GM Powder for Oral SolutionSY006a9eca-400f-47f5-bee5-facf7034043e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-306-0159779030601119 g in 1 BOTTLE (59779-306-01) 119 g2009-10-140000-00-00NoNoCurrent
59779-306-0259779030602238 g in 1 BOTTLE (59779-306-02) 238 g2009-10-070000-00-00NoNoCurrent
59779-306-0359779030603510 g in 1 BOTTLE (59779-306-03) 510 g2009-10-140000-00-00NoNoCurrent
59779-306-0459779030604850 g in 1 BOTTLE (59779-306-04) 850 g2011-03-290000-00-00NoNoCurrent
59779-306-0959779030609765 g in 1 BOTTLE (59779-306-09) 765 g2025-03-03NoNoCurrent
59779-306-1759779030617289 g in 1 BOTTLE (59779-306-17) 289 g2014-02-110000-00-00NoNoCurrent
59779-306-1859779030618153 g in 1 BOTTLE153 gHistorical
59779-306-1959779030619595 g in 1 BOTTLE (59779-306-19) 595 g2014-04-230000-00-00NoNoCurrent
59779-306-525977903065210 POUCH in 1 CARTON (59779-306-52) / 17 g in 1 POUCH10 pouch2015-04-240000-00-00NoNoCurrent
59779-306-535977903065317 g in 1 POUCH17 gHistorical
59779-306-605977903066020 POUCH in 1 CARTON (59779-306-60) / 17 g in 1 POUCH20 pouch2020-05-050000-00-00NoNoCurrent