FDA.reportPublic FDA data

clearlax

Product NDC
59640-797
11-digit product format
596400797
Labeler code
59640
Product ID
59640-797_7a653744-4743-42bc-bc05-195a8abee466
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
H E B
Application
ANDA090685
Marketing category
ANDA
Marketing start
2023-01-17
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
clearlax
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2M7P15E5P
Rxcui876193, 880407

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
59640-797-02clearlax238 g in 1 BOTTLEPOWDER, FOR SOLUTION2382
59640-797-03clearlax510 g in 1 BOTTLEPOWDER, FOR SOLUTION5102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59640-797CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [H E B]2Current NDC, 2 package rows20230202_0b4b752d-045d-4ff0-8e50-5607d1a841a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
880407ClearLax 17 GM Powder for Oral SolutionPSN0b4b752d-045d-4ff0-8e50-5607d1a841a72
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN0b4b752d-045d-4ff0-8e50-5607d1a841a72
880407polyethylene glycol 3350 17000 MG Powder for Oral Solution [ClearLax]SBD0b4b752d-045d-4ff0-8e50-5607d1a841a72
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD0b4b752d-045d-4ff0-8e50-5607d1a841a72
880407ClearLax 17 GM Powder for Oral SolutionSY0b4b752d-045d-4ff0-8e50-5607d1a841a72
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY0b4b752d-045d-4ff0-8e50-5607d1a841a72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59640-797-0259640079702238 g in 1 BOTTLE (59640-797-02) 238 g2023-01-17NoNoHistorical
59640-797-0359640079703510 g in 1 BOTTLE (59640-797-03) 510 g2023-01-17NoNoHistorical