purelax

Product NDC
69842-458
11-digit product format
698420458
Labeler code
69842
Product ID
69842-458_c2f00796-37fc-425a-86a4-dd05d0f0efe9
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
2022-10-14
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-458-01purelax119 g in 1 BOTTLEPOWDER, FOR SOLUTION1192
69842-458-02purelax238 g in 1 BOTTLEPOWDER, FOR SOLUTION2382

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-458PURELAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CVS PHARMACY]2Current NDC, Legacy NDC, 2 package rows20221023_fc3b6006-a75a-41b3-9f0b-a3152df1363f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNfc3b6006-a75a-41b3-9f0b-a3152df1363f2
1010732Purelax 17 GM Powder for Oral SolutionPSNfc3b6006-a75a-41b3-9f0b-a3152df1363f2
1010732polyethylene glycol 3350 17000 MG Powder for Oral Solution [PureLax]SBDfc3b6006-a75a-41b3-9f0b-a3152df1363f2
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDfc3b6006-a75a-41b3-9f0b-a3152df1363f2
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYfc3b6006-a75a-41b3-9f0b-a3152df1363f2
1010732PureLax 17 GM Powder for Oral SolutionSYfc3b6006-a75a-41b3-9f0b-a3152df1363f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-458-0169842045801119 g in 1 BOTTLE (69842-458-01) 119 g2022-10-190000-00-00NoNoCurrent
69842-458-0269842045802238 g in 1 BOTTLE (69842-458-02) 238 g2022-10-140000-00-00NoNoCurrent