NDC 67510-0171

Gentle Laxative

Biisacodyl

Gentle Laxative is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Kareway Product, Inc.. The primary component is Bisacodyl.

Product ID67510-0171_786f3341-b5f3-496b-b249-7f935f8445c6
NDC67510-0171
Product TypeHuman Otc Drug
Proprietary NameGentle Laxative
Generic NameBiisacodyl
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2012-02-15
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart334
Labeler NameKareway Product, Inc.
Substance NameBISACODYL
Active Ingredient Strength5 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 67510-0171-2

2 BLISTER PACK in 1 BOX (67510-0171-2) > 10 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date2012-02-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67510-0171-2 [67510017102]

Gentle Laxative TABLET, COATED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-02-15
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
BISACODYL5 mg/1

OpenFDA Data

SPL SET ID:ccffcdc2-e065-40c3-bebb-051611694552
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308753
  • Pharm Class PE
  • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
  • Increased Large Intestinal Motility [PE]
  • PHarm Class EPC
  • Stimulant Laxative [EPC]
  • UPC Code
  • 0856023001711
  • NUI Code
  • N0000009371
  • N0000175812
  • N0000009871
  • NDC Crossover Matching brand name "Gentle Laxative" or generic name "Biisacodyl"

    NDCBrand NameGeneric Name
    0363-0327Gentle LaxativeBisacodyl
    0363-1634Gentle Laxativemagnesium hydroxide
    15127-676Gentle LaxativeBisacodyl
    33992-0676Gentle LaxativeBisacodyl
    36800-327Gentle LaxativeBisacodyl
    37205-128Gentle LaxativeBisacodyl
    37808-327Gentle LaxativeBisacodyl
    41163-607Gentle LaxativeBisacodyl
    41250-339gentle laxativeBisacodyl
    41520-019Gentle LaxativeBisacodyl
    43749-460Gentle LaxativeBisacodyl Suppository
    46122-529Gentle LaxativeBisacodyl
    49035-327Gentle LaxativeBisacodyl
    69517-116Gentle LaxativeGentle Laxative
    70000-0221Gentle LaxativeGentle Laxative
    49348-032gentle laxativegentle laxative
    50844-607Gentle LaxativeGentle Laxative
    50844-327Gentle LaxativeGentle Laxative
    55910-327Gentle LaxativeGentle Laxative
    59779-327Gentle LaxativeGentle Laxative
    63940-327Gentle LaxativeGentle Laxative
    67510-0171Gentle LaxativeGentle Laxative
    70518-2116Gentle LaxativeGentle Laxative
    70000-0538Gentle LaxativeGentle Laxative
    49035-706Gentle LaxativeGentle Laxative

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