NDC 11523-4357

MiraLAX

Polyethylene Glycol 3350

MiraLAX is a Oral Powder, For Solution in the Human Otc Drug category. It is labeled and distributed by Bayer Healthcare Llc.. The primary component is Polyethylene Glycol 3350.

Product ID11523-4357_7a193c00-eb95-64fa-e053-2a91aa0a4e48
NDC11523-4357
Product TypeHuman Otc Drug
Proprietary NameMiraLAX
Generic NamePolyethylene Glycol 3350
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2007-02-01
Marketing CategoryNDA / NDA
Application NumberNDA022015
Labeler NameBayer HealthCare LLC.
Substance NamePOLYETHYLENE GLYCOL 3350
Active Ingredient Strength17 g/17g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 11523-4357-2

2 CARTON in 1 CARTON (11523-4357-2) > 20 PACKET in 1 CARTON > 17 g in 1 PACKET
Marketing Start Date2007-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11523-4357-5 [11523435705]

MiraLAX POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA022015
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-05-01

NDC 11523-4357-1 [11523435701]

MiraLAX POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA022015
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-02-01
Marketing End Date2018-01-01

NDC 11523-4357-2 [11523435702]

MiraLAX POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA022015
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-02-01

NDC 11523-4357-3 [11523435703]

MiraLAX POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA022015
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-02-01

Drug Details

Active Ingredients

IngredientStrength
POLYETHYLENE GLYCOL 335017 g/17g

OpenFDA Data

SPL SET ID:d69ce3d4-7ca4-4fe3-b49e-6655e48d6963
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 876195
  • 876193
    • UPC Code
  • 0041100806765
  • 0041100577528

    • NDC Crossover Matching brand name "MiraLAX" or generic name "Polyethylene Glycol 3350"

    NDCBrand NameGeneric Name
    11523-4357MiraLAXPolyethylene Glycol 3350
    11523-7234MiraLAXPolyethylene Glycol 3350
    11523-7341MiraLAXMiraLAX
    11523-7268MiraLAXMiraLAX
    55154-5035MiraLAXMiraLAX
    0113-7306Basic Care ClearlaxPolyethylene Glycol 3350
    0113-0306Good Sense Clear LaxPolyethylene Glycol 3350
    0113-1023good sense clearlaxPolyethylene Glycol 3350
    0113-6900injoy constipation reliefPolyethylene Glycol 3350
    0224-1890Mighty LaxPOLYETHYLENE GLYCOL 3350
    0904-6025peg 3350Polyethylene Glycol 3350
    0904-6422PEG 3350POLYETHYLENE GLYCOL 3350
    0574-0412Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350
    0722-6920Polyethylene Glycol 3350Polyethylene Glycol 3350
    0722-6921Polyethylene Glycol 3350Polyethylene Glycol 3350
    0904-6931Polyethylene glycol 3350Polyethylene glycol 3350
    10135-683Polyethylene Glycol 3350Polyethylene Glycol 3350
    0536-1052rugby PEG 3350POLYETHYLENE GLYCOL 3350
    0363-0306smooth laxPolyethylene Glycol 3350
    0363-0489Smooth LAXpolyethylene glycol 3350

    Trademark Results [MiraLAX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MIRALAX
    MIRALAX
    85746766 4426594 Live/Registered
    BAYER HEALTHCARE LLC
    2012-10-05
    MIRALAX
    MIRALAX
    78686831 3120379 Live/Registered
    Bayer HealthCare LLC
    2005-08-05
    MIRALAX
    MIRALAX
    77753736 3735255 Dead/Cancelled
    BAYER CONSUMER CARE HOLDINGS LLC
    2009-06-05
    MIRALAX
    MIRALAX
    77753735 3735254 Dead/Cancelled
    BAYER CONSUMER CARE HOLDINGS LLC
    2009-06-05
    MIRALAX
    MIRALAX
    77702783 not registered Dead/Abandoned
    MSD Consumer Care, Inc.
    2009-03-31
    MIRALAX
    MIRALAX
    77097551 3412356 Dead/Cancelled
    BAYER CONSUMER CARE HOLDINGS LLC
    2007-02-02
    MIRALAX
    MIRALAX
    75622252 2982512 Dead/Cancelled
    SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.
    1999-01-15
    MIRALAX
    MIRALAX
    75109262 not registered Dead/Abandoned
    Braintree Laboratories, Inc.
    1996-05-24
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