Colace Tablet, Film Coated
NDC 67618-110

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 67618-110?
  5. Colace Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Patient Education

Product Information

Colace (docusate sodium - sennosides) is a OTC MONOGRAPH DRUG-approved product labeled by Atlantis Consumer Healthcare, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a red tablet, film coated for oral administration. This product entry covers the primary NDC 67618-110 and 4 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
67618-110
Proprietary Name:
Colace
Non-Proprietary Name: [1]
Docusate Sodium - Sennosides
Substance Name: [2]
Docusate Sodium; Sennosides
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Atlantis Consumer Healthcare, Inc.
Labeler Code:
67618
Product Label ID:
9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b
FDA Application Number: [6]
M007
Marketing Category: [8]
OTC MONOGRAPH DRUG

Marketing Timeline

Start Marketing Date: [9]
02-08-1957
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
RED (C48326 - BURGUNDY)
Shape:
ROUND (C48348)
Size(s):
10 MM
Imprint(s):
P;054
Score:
1

Code Structure Chart

Product Details

What is NDC 67618-110?

The NDC code 67618-110 is assigned by the FDA to the product Colace. It is commonly known by its generic name, docusate sodium - sennosides. This pharmaceutical product is labeled by Atlantis Consumer Healthcare, Inc. and is currently categorized as listed product. The medication is a tablet, film coated administered via oral route. In terms of distribution, this product is available in 4 different package configurations. The associated package NDC(s) include: 67618-110-10, 67618-110-12, 67618-110-30, 67618-110-60. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Usesrelieves occasional constipation (irregularity)generally produces bowel movement in 6 to 12 hours

What are Active Ingredients of this product?

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.
  • DOCUSATE SODIUM 50 mg/1 - All-purpose surfactant, wetting agent, and solubilizer used in the drug, cosmetics, and food industries. It has also been used in laxatives and as cerumenolytics. It is usually administered as either the calcium, potassium, or sodium salt.
  • SENNOSIDES 8.6 mg/1 - Medications derived from SENNA EXTRACT that are used to treat CONSTIPATION.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated 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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

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:
  • RxCUI: 1872920 - Colace w/Sennosides 50 MG / 8.6 MG Oral Tablet
  • RxCUI: 1872920 - docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Colace w/Sennosides]
  • RxCUI: 1872920 - Colace w/Sennosides (docusate sodium 50 MG / sennosides, USP 8.6 MG) Oral Tablet
  • RxCUI: 1872920 - DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Colace w/Sennosides]
  • RxCUI: 998740 - sennosides 8.6 MG / docusate sodium 50 MG Oral Tablet

* Please review the full disclaimer at the bottom of this page.

Patient Education

Senna


Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.
[Learn More]


Stool Softeners


Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoids, and other problems. They work by softening stools to make them easier to pass.
[Learn More]


Senna


What is it? Senna is the fruit (pod) or leaf of the plant Senna alexandrina. It is approved in the US as a laxative for short-term treatment of constipation.

Senna contains many chemicals called sennosides. Sennosides irritate the lining of the bowel, which causes a laxative effect.

Senna is an FDA-approved over-the-counter (OTC) laxative. It is used to treat constipation and also to clear the bowel before procedures such as colonoscopy. People also use senna for irritable bowel syndrome (IBS), hemorrhoids, weight loss, and many other conditions, but there is no good scientific evidence to support these uses.


[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".