NDC 0597-0330

DulcoEase

Docusate Sodium

DulcoEase is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Docusate Sodium.

Product ID0597-0330_4ecfae3d-e883-5663-6ea6-046e92916247
NDC0597-0330
Product TypeHuman Otc Drug
Proprietary NameDulcoEase
Generic NameDocusate Sodium
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-07-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart334
Labeler NameBoehringer Ingelheim Pharmaceuticals, Inc.
Substance NameDOCUSATE SODIUM
Active Ingredient Strength100 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0597-0330-01

1 BOTTLE in 1 CARTON (0597-0330-01) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Start Date2016-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0330-89 [00597033089]

DulcoEase CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-01

NDC 0597-0330-01 [00597033001]

DulcoEase CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-01

NDC 0597-0330-28 [00597033028]

DulcoEase CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-01

NDC 0597-0330-57 [00597033057]

DulcoEase CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-01

NDC 0597-0330-10 [00597033010]

DulcoEase CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-01
Marketing End Date2016-06-01

NDC 0597-0330-83 [00597033083]

DulcoEase CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-01

Drug Details

Active Ingredients

IngredientStrength
DOCUSATE SODIUM100 mg/1

OpenFDA Data

SPL SET ID:b1782087-d411-5cc9-3fe9-7e88c4b7eff8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1115005
  • 1798994
  • NDC Crossover Matching brand name "DulcoEase" or generic name "Docusate Sodium"

    NDCBrand NameGeneric Name
    0597-0330DulcoEaseDulcoEase
    0113-7004basic care stool softenerDocusate sodium
    0121-0544Docusate SodiumDocusate Sodium
    0363-0655Gentle Stool SoftenerDocusate sodium
    0113-0486good sense stool softenerDocusate sodium
    0363-6550LaxativeDocusate Sodium
    0132-0106Pedia-LaxDocusate Sodium
    0280-1012Phillips Stool Softenerdocusate sodium
    0363-0238Stool SoftenerDOCUSATE SODIUM
    0363-0239Stool SoftenerDOCUSATE SODIUM
    0363-5790Stool SoftenerDocusate Sodium
    0363-8540Stool SoftenerDocusate Sodium
    0363-0016Stool Softener LaxativeDOCUSATE SODIUM
    0363-0679Stool Softener LaxativeDOCUSATE SODIUM
    0363-4100Stool Softener LaxativeDocusate Sodium
    0363-4202Stool Softener LaxativeDocusate Sodium
    0363-8530Stool Softener LaxativeDocusate Sodium
    0363-7140Walgreens Stool SoftenerDocusate sodium

    Trademark Results [DulcoEase]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DULCOEASE
    DULCOEASE
    79066924 3667064 Live/Registered
    Sanofi-Aventis Deutschland GmbH
    2008-12-22

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