NDC 0597-0012

Dulcolax

Bisacodyl

Dulcolax is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Bisacodyl.

Product ID0597-0012_7e3d2ba1-1ea6-62e3-d82d-a0f19a906bb3
NDC0597-0012
Product TypeHuman Otc Drug
Proprietary NameDulcolax
Generic NameBisacodyl
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2001-10-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart334
Labeler NameBoehringer Ingelheim Pharmaceuticals, Inc.
Substance NameBISACODYL
Active Ingredient Strength5 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0597-0012-00

4 BLISTER PACK in 1 CARTON (0597-0012-00) > 25 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date2001-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0012-11 [00597001211]

Dulcolax TABLET, COATED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2001-10-01

NDC 0597-0012-33 [00597001233]

Dulcolax TABLET, COATED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2001-10-01
Marketing End Date2016-06-06

NDC 0597-0012-38 [00597001238]

Dulcolax TABLET, COATED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2001-10-01

NDC 0597-0012-00 [00597001200]

Dulcolax TABLET, COATED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2001-10-01

NDC 0597-0012-79 [00597001279]

Dulcolax TABLET, COATED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2001-10-01
Marketing End Date2016-06-06

NDC 0597-0012-50 [00597001250]

Dulcolax TABLET, COATED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2001-10-01

NDC 0597-0012-26 [00597001226]

Dulcolax TABLET, COATED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2001-10-01

NDC 0597-0012-59 [00597001259]

Dulcolax TABLET, COATED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2001-10-01

NDC 0597-0012-37 [00597001237]

Dulcolax TABLET, COATED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2001-10-01

NDC 0597-0012-58 [00597001258]

Dulcolax TABLET, COATED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2001-10-01

NDC 0597-0012-34 [00597001234]

Dulcolax TABLET, COATED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2001-10-01
Marketing End Date2016-06-06

Drug Details

Active Ingredients

IngredientStrength
BISACODYL5 mg/1

OpenFDA Data

SPL SET ID:8527ae95-fdfd-4b62-9f56-598c2656aeb6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308753
  • 209613
    • Pharm Class PE
  • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
  • Increased Large Intestinal Motility [PE]
    • PHarm Class EPC
  • Stimulant Laxative [EPC]
    • NUI Code
  • N0000009371
  • N0000175812
  • N0000009871

    • NDC Crossover Matching brand name "Dulcolax" or generic name "Bisacodyl"

    NDCBrand NameGeneric Name
    0597-0012Dulcolaxbisacodyl
    0597-0016DulcolaxDocusate sodium
    0597-0052DulcolaxBisacodyl
    0597-0162DulcolaxBisacodyl
    0597-0340Dulcolaxbisacodyl
    29485-6741DulcolaxDulcolax
    0713-0109BISAC-EVACBisacodyl
    0574-7050Bisacodylbisacodyl
    0904-6748BisacodylBisacodyl
    0904-7142BisacodylBisacodyl
    0904-7927BisacodylBisacodyl
    0536-1355BiscolaxBisacodyl
    0904-5058Biscolax LaxativeBisacodyl
    0597-0051Dulcolax Pinkbisacodyl
    0597-0169Dulcolax Pinkbisacodyl
    0597-0335Dulcolax Pinkbisacodyl
    0536-3381Enteric Coated Stimulant LaxativeBisacodyl
    0132-0703FleetBisacodyl
    0363-0327Gentle LaxativeBisacodyl
    0363-6760LaxativeBisacodyl
    0904-6407Unit Dose BisacodylBisacodyl
    0363-3011WOMENS GENTLE LAXATIVEBISACODYL
    0363-0676Womens laxativeBisacodyl

    Trademark Results [Dulcolax]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DULCOLAX
    DULCOLAX
    79043985 3505530 Live/Registered
    Sanofi-Aventis Deutschland GmbH
    2007-08-16
    DULCOLAX
    DULCOLAX
    78157653 2861373 Dead/Cancelled
    Boehringer Ingelheim International GmbH
    2002-08-26
    DULCOLAX
    DULCOLAX
    72042116 0671422 Live/Registered
    DR, KARL THOMAE GMBH
    1957-12-10
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