FDA.reportPublic FDA data

good sense clearlax

Product NDC
0113-1023
11-digit product format
001131023
Labeler code
0113
Product ID
0113-1023_6ef82ee5-bac5-4a80-8513-52265a66a3ed
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA090685
Marketing category
ANDA
Marketing start
2022-12-27
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
good sense 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
0113-1023-02good sense clearlax238 g in 1 BOTTLEPOWDER, FOR SOLUTION2382
0113-1023-03good sense clearlax510 g in 1 BOTTLEPOWDER, FOR SOLUTION5102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-1023-02GM - Gram0113-102373cd7497-cdd5-4257-80ea-51874094317f12024-02-14
0113-1023-03GM - Gram0113-1023d7201fc4-960e-41fd-b670-290716f37b7912024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-1023GOOD SENSE CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [L. PERRIGO COMPANY]2Current NDC, Legacy NDC, 2 package rows20230613_9858edef-cdb2-4ac4-8e4b-ba0720a24e41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
880407ClearLax 17 GM Powder for Oral SolutionPSN9858edef-cdb2-4ac4-8e4b-ba0720a24e412
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN9858edef-cdb2-4ac4-8e4b-ba0720a24e412
880407polyethylene glycol 3350 17000 MG Powder for Oral Solution [ClearLax]SBD9858edef-cdb2-4ac4-8e4b-ba0720a24e412
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD9858edef-cdb2-4ac4-8e4b-ba0720a24e412
880407ClearLax 17 GM Powder for Oral SolutionSY9858edef-cdb2-4ac4-8e4b-ba0720a24e412
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY9858edef-cdb2-4ac4-8e4b-ba0720a24e412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-1023-0200113102302238 g in 1 BOTTLE (0113-1023-02) 238 g2023-05-15NoNoHistorical
0113-1023-0300113102303510 g in 1 BOTTLE (0113-1023-03) 510 g2022-12-270000-00-00NoNoCurrent