NDC 41167-0400

Dulcolax Stimulant Laxative

Bisacodyl

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

Product ID41167-0400_19191abb-e95a-4721-b5b3-c06e55fea7a6
NDC41167-0400
Product TypeHuman Otc Drug
Proprietary NameDulcolax Stimulant Laxative
Generic NameBisacodyl
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2019-04-14
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart334
Labeler NameChattem, Inc.
Substance NameBISACODYL
Active Ingredient Strength5 mg/1
Pharm ClassesIncreased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 41167-0400-1

1 BLISTER PACK in 1 CARTON (41167-0400-1) > 10 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date2019-04-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 41167-0400-3 [41167040003]

Dulcolax Stimulant Laxative TABLET, COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-04-14

NDC 41167-0400-2 [41167040002]

Dulcolax Stimulant Laxative TABLET, COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart334
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-04-14

NDC 41167-0400-8 [41167040008]

Dulcolax Stimulant Laxative TABLET, COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-01

NDC 41167-0400-1 [41167040001]

Dulcolax Stimulant Laxative TABLET, COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-04-14

NDC 41167-0400-4 [41167040004]

Dulcolax Stimulant Laxative TABLET, COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-03

NDC 41167-0400-6 [41167040006]

Dulcolax Stimulant Laxative TABLET, COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-04-14

NDC 41167-0400-5 [41167040005]

Dulcolax Stimulant Laxative TABLET, COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-04-14

Drug Details

Active Ingredients

IngredientStrength
BISACODYL5 mg/1

OpenFDA Data

SPL SET ID:f1e4b28a-ed74-4eff-bd10-b2bfaf7483b0
Manufacturer
UNII
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 Stimulant Laxative" or generic name "Bisacodyl"

    NDCBrand NameGeneric Name
    41167-0200Dulcolax Stimulant LaxativeDulcolax Stimulant Laxative
    41167-0400Dulcolax Stimulant LaxativeDulcolax Stimulant Laxative
    0713-0109BISAC-EVACBisacodyl
    0574-7050Bisacodylbisacodyl
    0904-6748BisacodylBisacodyl
    0904-7142BisacodylBisacodyl
    0904-7927BisacodylBisacodyl
    0536-1355BiscolaxBisacodyl
    0904-5058Biscolax LaxativeBisacodyl
    10237-906Carters Little PillsBisacodyl
    0597-0012Dulcolaxbisacodyl
    0597-0052DulcolaxBisacodyl
    0597-0162DulcolaxBisacodyl
    0597-0340Dulcolaxbisacodyl
    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

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