FDA.reportPublic FDA data

MiraLAX

Product NDC
11523-7268
11-digit product format
115237268
Labeler code
11523
Product ID
11523-7268_51040c1b-71bf-bb83-e063-6294a90aca4e
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA022015
Marketing category
NDA
Marketing start
2007-02-01
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
MiraLAX
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2M7P15E5P
Rxcui876193, 876195

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
11523-7268-3MiraLAX10 in 1 CARTONPOWDER, FOR SOLUTION1024
11523-7268-3MiraLAX17 g in 1 PACKETPOWDER, FOR SOLUTION1724
11523-7268-4MiraLAX765 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION76524
11523-7268-5MiraLAX850 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION85024
11523-7268-7MiraLAX5 in 1 CARTONPOWDER, FOR SOLUTION524
11523-7268-7MiraLAX17 g in 1 PACKETPOWDER, FOR SOLUTION1724
11523-7268-8MiraLAX17 g in 1 PACKETPOWDER, FOR SOLUTION1724
11523-7268-8MiraLAX24 in 1 CARTONPOWDER, FOR SOLUTION2424
11523-7268-9MiraLAX20 in 1 CARTONPOWDER, FOR SOLUTION2024
11523-7268-9MiraLAX17 g in 1 POUCHPOWDER, FOR SOLUTION1724

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-7268-3EA - Each11523-7268933e3d13-3afb-4f83-a441-303e0e1f21ab12012-07-24
11523-7268-4GM - Gram11523-7268450ecaa3-e208-4d65-96a1-a40b2428691612016-04-04
11523-7268-8EA - Each11523-7268ba0fa4db-d34f-46d4-8e2d-f2141ba5d5bc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Polyethylene Glycol 3350ACTIVE INGREDIENTG2M7P15E5PMIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [MSD CONSUMER CARE, INC.]9
Polyethylene Glycol 3350ACTIVE MOIETYG2M7P15E5PMIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [MSD CONSUMER CARE, INC.]9
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PMIRALAX (POLYETHYLENE GLYCOL 3350) POWDER [CARDINAL HEALTH]4
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PMIRALAX (POLYETHYLENE GLYCOL 3350) POWDER [CARDINAL HEALTH]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-7268MIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.]22Current NDC, Legacy NDC, 10 package rows20241208_d69ce3d4-7ca4-4fe3-b49e-6655e48d6963.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876195MiraLAX 17 GM Powder for Oral SolutionPSNd69ce3d4-7ca4-4fe3-b49e-6655e48d696324
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNd69ce3d4-7ca4-4fe3-b49e-6655e48d696324
876195polyethylene glycol 3350 17000 MG Powder for Oral Solution [Miralax]SBDd69ce3d4-7ca4-4fe3-b49e-6655e48d696324
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDd69ce3d4-7ca4-4fe3-b49e-6655e48d696324
876195Miralax 17 GM Powder for Oral SolutionSYd69ce3d4-7ca4-4fe3-b49e-6655e48d696324
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYd69ce3d4-7ca4-4fe3-b49e-6655e48d696324
876195MiraLAX 17 GM Powder for Oral SolutionPSN1771d3bf-954d-49ea-b260-3d356e5dcfa517
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN1771d3bf-954d-49ea-b260-3d356e5dcfa517
876195polyethylene glycol 3350 17000 MG Powder for Oral Solution [Miralax]SBD1771d3bf-954d-49ea-b260-3d356e5dcfa517
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD1771d3bf-954d-49ea-b260-3d356e5dcfa517
876195Miralax 17 GM Powder for Oral SolutionSY1771d3bf-954d-49ea-b260-3d356e5dcfa517
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY1771d3bf-954d-49ea-b260-3d356e5dcfa517
876195MiraLAX 17 GM Powder for Oral SolutionPSNe652042f-3707-4bf6-831d-d806638b7d851
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNe652042f-3707-4bf6-831d-d806638b7d851
876195polyethylene glycol 3350 17000 MG Powder for Oral Solution [Miralax]SBDe652042f-3707-4bf6-831d-d806638b7d851
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDe652042f-3707-4bf6-831d-d806638b7d851
876195Miralax 17 GM Powder for Oral SolutionSYe652042f-3707-4bf6-831d-d806638b7d851
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYe652042f-3707-4bf6-831d-d806638b7d851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-7268-31152372680310 PACKET in 1 CARTON (11523-7268-3) / 17 g in 1 PACKET10 packet2007-02-010000-00-00NoNoCurrent
11523-7268-411523726804765 g in 1 BOTTLE, PLASTIC (11523-7268-4) 765 g2007-02-010000-00-00NoNoCurrent
11523-7268-511523726805850 g in 1 BOTTLE, PLASTIC (11523-7268-5) 850 g2025-05-30NoNoCurrent
11523-7268-7115237268075 in 1 CARTONHistorical
11523-7268-81152372680824 PACKET in 1 CARTON (11523-7268-8) / 17 g in 1 PACKET24 packet2007-02-010000-00-00NoNoCurrent
11523-7268-91152372680920 POUCH in 1 CARTON (11523-7268-9) / 17 g in 1 POUCH20 pouch2007-02-010000-00-00NoNoCurrent