FDA.reportPublic FDA data

MiraLAX

Product NDC
11523-7234
11-digit product format
115237234
Labeler code
11523
Product ID
11523-7234_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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11523-7234-12025-07-30C16284748780-13b156c62-29f8-fb37-e063-e6dba90a4e07MiraLAX ®
11523-7234-22025-07-30C16284748780-13b156c62-29f8-fb37-e063-e6dba90a4e07MiraLAX ®
11523-7234-32025-07-30C16284748780-13b156c62-29f8-fb37-e063-e6dba90a4e07MiraLAX ®
11523-7234-42025-07-30C16284748780-13b156c62-29f8-fb37-e063-e6dba90a4e07MiraLAX ®
11523-7234-52025-07-30C16284748780-13b156c62-29f8-fb37-e063-e6dba90a4e07MiraLAX ®
11523-7234-62025-07-30C16284748780-13b156c62-29f8-fb37-e063-e6dba90a4e07MiraLAX ®
11523-7234-92025-07-30C16284748780-13b156c62-29f8-fb37-e063-e6dba90a4e07MiraLAX ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-7234-1MiraLAX17 g in 1 PACKETPOWDER, FOR SOLUTION1724
11523-7234-2MiraLAX119 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION11924
11523-7234-3MiraLAX238 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION23824
11523-7234-4MiraLAX510 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION51024
11523-7234-5MiraLAX12 in 1 CARTONPOWDER, FOR SOLUTION1224
11523-7234-5MiraLAX17 g in 1 PACKETPOWDER, FOR SOLUTION1724
11523-7234-6MiraLAX17 g in 1 PACKETPOWDER, FOR SOLUTION1724
11523-7234-9MiraLAX510 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION51024
11523-7234-9MiraLAX2 in 1 CELLO PACKPOWDER, FOR SOLUTION224

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-7234-1EA - Each11523-723455e271fb-6c6f-421d-b6e4-95492312426412016-09-02
11523-7234-2GM - Gram11523-7234a9425dbc-97ad-4f69-a459-59186636a12e12012-07-24
11523-7234-3GM - Gram11523-7234d96b225f-ad80-4062-98ba-8bc9bc60e7a712012-07-24
11523-7234-4GM - Gram11523-72345c8972d7-9975-4673-9f12-300366b3845712012-07-24
11523-7234-5EA - Each11523-72348360e484-598b-49ed-a4a4-084273195d5512012-07-24
11523-7234-9GM - Gram11523-72346758025b-2d46-43e2-9d60-c4ff4e5a025d12012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-7234MIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.]22Current NDC, Legacy NDC, 9 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-7234-11152372340117 g in 1 PACKET (11523-7234-1) 17 g2007-02-010000-00-00NoNoCurrent
11523-7234-211523723402119 g in 1 BOTTLE, PLASTIC (11523-7234-2) 119 g2007-02-010000-00-00NoNoCurrent
11523-7234-311523723403238 g in 1 BOTTLE, PLASTIC (11523-7234-3) 238 g2007-02-010000-00-00NoNoCurrent
11523-7234-411523723404510 g in 1 BOTTLE, PLASTIC (11523-7234-4) 510 g2007-02-010000-00-00NoNoCurrent
11523-7234-51152372340512 in 1 CARTONHistorical
11523-7234-61152372340617 g in 1 PACKET (11523-7234-6) 17 g2007-02-010000-00-00NoNoCurrent
11523-7234-911523723409510 g in 1 BOTTLE, PLASTIC510 gHistorical