FDA.reportPublic FDA data

Topcare ClearLax

Product NDC
36800-306
11-digit product format
368000306
Labeler code
36800
Product ID
36800-306_05d0b5e4-4bde-4c30-8742-f8e7f8e5859c
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Topco Associates LLC
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare ClearLax
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-306-012026-01-29C16284748780-149896155-b9bf-586f-e063-e6dba90add90Topco Associates LLC. ClearLax ® Drug Facts
36800-306-022026-01-29C16284748780-149896155-b9bf-586f-e063-e6dba90add90Topco Associates LLC. ClearLax ® Drug Facts
36800-306-032026-01-29C16284748780-149896155-b9bf-586f-e063-e6dba90add90Topco Associates LLC. ClearLax ® Drug Facts
36800-306-042026-01-29C16284748780-149896155-b9bf-586f-e063-e6dba90add90Topco Associates LLC. ClearLax ® Drug Facts
36800-306-072026-01-29C16284748780-149896155-b9bf-586f-e063-e6dba90add90Topco Associates LLC. ClearLax ® Drug Facts
36800-306-082026-01-29C16284748780-149896155-b9bf-586f-e063-e6dba90add90Topco Associates LLC. ClearLax ® Drug Facts
36800-306-092026-01-29C16284748780-149896155-b9bf-586f-e063-e6dba90add90Topco Associates LLC. ClearLax ® Drug Facts
36800-306-192026-01-29C16284748780-149896155-b9bf-586f-e063-e6dba90add90Topco Associates LLC. ClearLax ® Drug Facts
36800-306-202026-01-29C16284748780-149896155-b9bf-586f-e063-e6dba90add90Topco Associates LLC. ClearLax ® Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-306-01Topcare ClearLax119 g in 1 BOTTLEPOWDER, FOR SOLUTION11912
36800-306-02Topcare ClearLax238 g in 1 BOTTLEPOWDER, FOR SOLUTION23812
36800-306-03Topcare ClearLax507 g in 1 BOTTLEPOWDER, FOR SOLUTION50712
36800-306-04Topcare ClearLax850 g in 1 BOTTLEPOWDER, FOR SOLUTION85012
36800-306-07Topcare ClearLax3 in 1 PACKAGEPOWDER, FOR SOLUTION312
36800-306-07Topcare ClearLax510 g in 1 BOTTLEPOWDER, FOR SOLUTION51012
36800-306-08Topcare ClearLax2 in 1 PACKAGEPOWDER, FOR SOLUTION212
36800-306-08Topcare ClearLax238 g in 1 BOTTLEPOWDER, FOR SOLUTION23812
36800-306-09Topcare ClearLax765 g in 1 BOTTLEPOWDER, FOR SOLUTION76512
36800-306-19Topcare ClearLax595 g in 1 BOTTLEPOWDER, FOR SOLUTION59512
36800-306-20Topcare ClearLax2 in 1 PACKAGEPOWDER, FOR SOLUTION212
36800-306-20Topcare ClearLax850 g in 1 BOTTLEPOWDER, FOR SOLUTION85012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-306-01GM - Gram36800-30666b3dac0-dd64-4e4b-a2fa-ec6b364ed3e412012-07-24
36800-306-02GM - Gram36800-3068ea82a42-377e-46c1-a40a-e6072851354b12012-07-24
36800-306-03GM - Gram36800-3065f08a0ca-87cc-4af3-8fe0-4bc6ec1428f712012-07-24
36800-306-04GM - Gram36800-306d4196374-617e-42b4-986b-b421d87bfdc412012-07-24
36800-306-52EA - Each36800-306b44d6ef0-6c7f-4def-ad42-2758b80cc96112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PTOPCARE CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC]4
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PTOPCARE CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-306TOPCARE CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC]11Current NDC, Legacy NDC, 12 package rows20221118_03291fd3-7b64-4b79-ad84-e1b9b30a6b03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
880407ClearLax 17 GM Powder for Oral SolutionPSN03291fd3-7b64-4b79-ad84-e1b9b30a6b0312
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN03291fd3-7b64-4b79-ad84-e1b9b30a6b0312
880407polyethylene glycol 3350 17000 MG Powder for Oral Solution [ClearLax]SBD03291fd3-7b64-4b79-ad84-e1b9b30a6b0312
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD03291fd3-7b64-4b79-ad84-e1b9b30a6b0312
880407ClearLax 17 GM Powder for Oral SolutionSY03291fd3-7b64-4b79-ad84-e1b9b30a6b0312
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY03291fd3-7b64-4b79-ad84-e1b9b30a6b0312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-306-0136800030601119 g in 1 BOTTLE (36800-306-01) 119 g2009-10-070000-00-00NoNoCurrent
36800-306-0236800030602238 g in 1 BOTTLE (36800-306-02) 238 g2009-10-070000-00-00NoNoCurrent
36800-306-0336800030603507 g in 1 BOTTLE (36800-306-03) 507 g2009-10-070000-00-00NoNoCurrent
36800-306-0436800030604850 g in 1 BOTTLE850 gHistorical
36800-306-07368000306073 BOTTLE in 1 PACKAGE (36800-306-07) > 510 g in 1 BOTTLE3 bottle2009-10-072022-12-01NoNoCurrent
36800-306-08368000306082 in 1 PACKAGEHistorical
36800-306-0936800030609765 g in 1 BOTTLE (36800-306-09) 765 g2022-09-260000-00-00NoNoCurrent
36800-306-1936800030619595 g in 1 BOTTLE (36800-306-19) 595 g2013-08-210000-00-00NoNoCurrent
36800-306-20368000306202 BOTTLE in 1 PACKAGE (36800-306-20) / 850 g in 1 BOTTLE2 bottle2020-03-180000-00-00NoNoCurrent