FDA.reportPublic FDA data

smooth lax

Product NDC
0363-0306
11-digit product format
003630306
Labeler code
0363
Product ID
0363-0306_c677ed05-f149-4430-baba-d65b43cd1828
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Walgreen Company
Application
ANDA090685
Marketing category
ANDA
Marketing start
2009-10-09
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
smooth lax
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2M7P15E5P
Rxcui876193

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
0363-0306-00smooth lax17 g in 1 POUCHPOWDER, FOR SOLUTION1717
0363-0306-01smooth lax119 g in 1 BOTTLEPOWDER, FOR SOLUTION11917
0363-0306-02smooth lax238 g in 1 BOTTLEPOWDER, FOR SOLUTION23817
0363-0306-03smooth lax510 g in 1 BOTTLEPOWDER, FOR SOLUTION51017
0363-0306-04smooth lax850 g in 1 BOTTLEPOWDER, FOR SOLUTION85017
0363-0306-09smooth lax765 g in 1 BOTTLEPOWDER, FOR SOLUTION76517
0363-0306-10smooth lax612 g in 1 BOTTLEPOWDER, FOR SOLUTION61217
0363-0306-19smooth lax595 g in 1 BOTTLEPOWDER, FOR SOLUTION59517
0363-0306-52smooth lax10 in 1 CARTONPOWDER, FOR SOLUTION1017
0363-0306-60smooth lax20 in 1 CARTONPOWDER, FOR SOLUTION2017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0306-01GM - Gram0363-0306e93297f8-0920-40ce-9cc3-45a91274a07b12022-06-06
0363-0306-02GM - Gram0363-03060ce435d2-490f-464c-9f7c-fbd8425b39db12012-07-24
0363-0306-03GM - Gram0363-03063bb5adab-b972-40d4-97d2-da67c9cda8fd12012-07-24
0363-0306-04GM - Gram0363-0306a5bae08e-2124-4c94-9066-75b4641ebd8412012-07-24
0363-0306-10GM - Gram0363-030688256a7a-1278-4b70-ac16-38794d0a879a12022-06-06
0363-0306-52EA - Each0363-0306a3fd2a97-3740-46e9-9631-2ffcc50ad58d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PSMOOTH LAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [WALGREEN COMPANY]5
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PSMOOTH LAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [WALGREEN COMPANY]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0306SMOOTH LAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [WALGREEN COMPANY]15Current NDC, Legacy NDC, 10 package rows20241217_3027af65-2f7f-472d-83f5-254d5d75013c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN3027af65-2f7f-472d-83f5-254d5d75013c17
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD3027af65-2f7f-472d-83f5-254d5d75013c17
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY3027af65-2f7f-472d-83f5-254d5d75013c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0306-000036303060017 g in 1 POUCH (0363-0306-00) 17 g2010-04-270000-00-00NoNoCurrent
0363-0306-0100363030601119 g in 1 BOTTLE (0363-0306-01) 119 g2015-04-100000-00-00NoNoCurrent
0363-0306-0200363030602238 g in 1 BOTTLE (0363-0306-02) 238 g2009-10-090000-00-00NoNoCurrent
0363-0306-0300363030603510 g in 1 BOTTLE (0363-0306-03) 510 g2009-10-090000-00-00NoNoCurrent
0363-0306-0400363030604850 g in 1 BOTTLE850 gHistorical
0363-0306-0900363030609765 g in 1 BOTTLE (0363-0306-09) 765 g2015-04-100000-00-00NoNoCurrent
0363-0306-1000363030610612 g in 1 BOTTLE (0363-0306-10) 612 g2015-04-160000-00-00NoNoCurrent
0363-0306-1900363030619595 g in 1 BOTTLE (0363-0306-19) 595 g2024-12-14NoNoHistorical
0363-0306-520036303065210 POUCH in 1 CARTON (0363-0306-52) / 17 g in 1 POUCH (0363-0306-00) 10 pouch2010-04-270000-00-00NoNoCurrent
0363-0306-600036303066020 POUCH in 1 CARTON (0363-0306-60) / 17 g in 1 POUCH (0363-0306-00) 20 pouch2019-05-280000-00-00NoNoCurrent