MiraLAX

Product NDC
55154-5035
11-digit product format
551545035
Labeler code
55154
Product ID
55154-5035_a30d3776-09c8-41aa-9282-ba2486632e07
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
NDA022015
Marketing category
NDA
Marketing start
2009-02-23
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
MiraLAX
Listing expiration
2026-12-31

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
55154-5035-6MiraLAX6 in 1 BAGPOWDER, FOR SOLUTION617
55154-5035-6MiraLAX17 g in 1 PACKETPOWDER, FOR SOLUTION1717

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
55154-5035MIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CARDINAL HEALTH 107, LLC]16Current NDC, Legacy NDC, 2 package rows20250305_1771d3bf-954d-49ea-b260-3d356e5dcfa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-5035-6551545035066 PACKET in 1 BAG (55154-5035-6) / 17 g in 1 PACKET6 packet2009-02-230000-00-00NoNoCurrent