FDA.reportPublic FDA data

equaline clearlax

Product NDC
41163-306
11-digit product format
411630306
Labeler code
41163
Product ID
41163-306_ea8e5ed9-0754-4eae-8bf0-1416d5a7f943
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
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
equaline 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
41163-306-01equaline clearlax119 g in 1 BOTTLEPOWDER, FOR SOLUTION11911
41163-306-02equaline clearlax238 g in 1 BOTTLEPOWDER, FOR SOLUTION23811
41163-306-03equaline clearlax510 g in 1 BOTTLEPOWDER, FOR SOLUTION51011
41163-306-09equaline clearlax765 g in 1 BOTTLEPOWDER, FOR SOLUTION76511
41163-306-52equaline clearlax17 g in 1 POUCHPOWDER, FOR SOLUTION1711
41163-306-52equaline clearlax10 in 1 CARTONPOWDER, FOR SOLUTION1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-306EQUALINE CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [UNITED NATURAL FOODS, INC. DBA UNFI]11Current NDC, Legacy NDC, 6 package rows20230808_e0871542-9136-4cf8-a4b7-6c2b6edcbe0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
880407ClearLax 17 GM Powder for Oral SolutionPSNe0871542-9136-4cf8-a4b7-6c2b6edcbe0e11
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNe0871542-9136-4cf8-a4b7-6c2b6edcbe0e11
880407polyethylene glycol 3350 17000 MG Powder for Oral Solution [ClearLax]SBDe0871542-9136-4cf8-a4b7-6c2b6edcbe0e11
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDe0871542-9136-4cf8-a4b7-6c2b6edcbe0e11
880407ClearLax 17 GM Powder for Oral SolutionSYe0871542-9136-4cf8-a4b7-6c2b6edcbe0e11
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYe0871542-9136-4cf8-a4b7-6c2b6edcbe0e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-306-0141163030601119 g in 1 BOTTLE (41163-306-01) 119 g2009-10-070000-00-00NoNoCurrent
41163-306-0241163030602238 g in 1 BOTTLE (41163-306-02) 238 g2009-10-070000-00-00NoNoCurrent
41163-306-0341163030603510 g in 1 BOTTLE (41163-306-03) 510 g2009-10-070000-00-00NoNoCurrent
41163-306-0941163030609765 g in 1 BOTTLE (41163-306-09) 765 g2021-07-220000-00-00NoNoCurrent
41163-306-524116303065217 g in 1 POUCH17 gHistorical