NDC 41167-0210 Dulcolax Laxative
Bisacodyl Suppository Rectal

Product Information

What is NDC 41167-0210?

The NDC code 41167-0210 is assigned by the FDA to the UNFINISHED product Dulcolax Laxative which is a human over the counter drug product labeled by Chattem, Inc.. The generic name of Dulcolax Laxative is bisacodyl. The product's dosage form is suppository and is administered via rectal form. The product is distributed in 4 packages with assigned NDC codes 41167-0210-1 1 blister pack in 1 carton / 4 suppository in 1 blister pack, 41167-0210-2 2 blister pack in 1 carton / 4 suppository in 1 blister pack, 41167-0210-3 4 blister pack in 1 carton / 4 suppository in 1 blister pack, 41167-0210-5 7 blister pack in 1 carton / 4 suppository in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code41167-0210
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Dulcolax Laxative
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Bisacodyl
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Bisacodyl
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Otc Drug
Dosage FormSuppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Rectal - Administration to the rectum.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Chattem, Inc.
Labeler Code41167
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		part334
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		06-04-2019
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
Unfinished Product What is an Unfinished Product?
Not Available		Yes
NDC Code Structure

What are the uses for Dulcolax Laxative?


Product Characteristics

Color(s)WHITE (C48325)
ShapeBULLET (C48335)

Product Packages

NDC Code 41167-0210-1

Package Description: 1 BLISTER PACK in 1 CARTON / 4 SUPPOSITORY in 1 BLISTER PACK

NDC Code 41167-0210-2

Package Description: 2 BLISTER PACK in 1 CARTON / 4 SUPPOSITORY in 1 BLISTER PACK

NDC Code 41167-0210-3

Package Description: 4 BLISTER PACK in 1 CARTON / 4 SUPPOSITORY in 1 BLISTER PACK

NDC Code 41167-0210-5

Package Description: 7 BLISTER PACK in 1 CARTON / 4 SUPPOSITORY in 1 BLISTER PACK

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Product Details

What are Dulcolax Laxative Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • BISACODYL 10 mg/1 - A diphenylmethane stimulant laxative used for the treatment of CONSTIPATION and for bowel evacuation. (From Martindale, The Extra Pharmacopoeia, 30th ed, p871)

Dulcolax Laxative Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Dulcolax Laxative Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Dulcolax Laxative Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient (In Each Suppository)



Bisacodyl (USP) 10 mg


Purpose



Stimulant laxative


Use



  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 15 minutes to 1 hour

Warnings



For rectal use only


Ask A Doctor Before Use If You Have



  • stomach pain, nausea or vomiting  
  • noticed a sudden change in bowel habits that lasts more than 2 weeks

When Using This Product



it may cause stomach discomfort, faintness, rectal burning and mild cramps  


Stop Use And Ask A Doctor If



  • you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



adults and children 12 years of age and over       1 suppository in a single daily dose. Peel open plastic. Insert suppository into rectum, pointed end first. Retain about 15 to 20 minutes.

children 6 to under 12 years of age                         ½ suppository in a single daily dose

children under 6 years of age                               ask a doctor


Other Information



  • do not use if individual blister unit is open or torn
  • store at 20°-25°C (68°-77°F)  

Inactive Ingredient



hard fat


Questions?



Call 1-866-844-2798 or visit www.Dulcolax.com

Keep carton as it contains important product information.


Principal Display Panel



Dulcolax
Bisacodyl (USP) 10 mg Suppository/ Stimulant Laxative
MEDICATED LAXATIVE SUPPOSITORY
4
COMFORT SHAPED
SUPPOSITORIES
DO NOT SWALLOW

PRINCIPAL DISPLAY PANELDulcolaxBisacodyl (USP) 10 mg Suppository/ Stimulant LaxativeMEDICATED LAXATIVE SUPPOSITORY4COMFORT SHAPEDSUPPOSITORIESDO NOT SWALLOW - dulcolax medicated laxative suppository 01

PRINCIPAL DISPLAY PANELDulcolaxBisacodyl (USP) 10 mg Suppository/ Stimulant LaxativeMEDICATED LAXATIVE SUPPOSITORY4COMFORT SHAPEDSUPPOSITORIESDO NOT SWALLOW - dulcolax medicated laxative suppository 01


* Please review the disclaimer below.