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  4. NDC Product Code: 35916-0477 Docusate Sodium And Sennosides

NDC 35916-0477 Docusate Sodium And Sennosides

Capsule, Liquid Filled Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 35916-0477?
  5. Docusate Sodium And Sennosides Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Patient Education

Product Information

This code was recently added to the official NDC directory and the product has entered commercial distribution.

Get all the details for National Drug Code (NDC) 35916-0477 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
35916-0477
Proprietary Name:
Docusate Sodium And Sennosides
Non-Proprietary Name: [1]
Docusate Sodium And Sennosides
Substance Name: [2]
Docusate Sodium; Sennosides
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler Name: [5]
Softgel Healthcare Private Limited
Labeler Code:
35916
Product Label ID:
4842a767-bb12-9d85-e063-6294a90a19b5
FDA Application Number: [6]
M007
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
01-16-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331 - OPAQUE)
Shape:
OVAL (C48345)
Size(s):
12 MM
Imprint(s):
902
Score:
1

Code Structure Chart

Product Details

What is NDC 35916-0477?

The NDC code 35916-0477 is assigned by the FDA to the product Docusate Sodium And Sennosides which is a human over the counter drug product labeled by Softgel Healthcare Private Limited. The product's dosage form is capsule, liquid filled and is administered via oral form. The product is distributed in a single package with assigned NDC code 35916-0477-1 2 bag in 1 box / 1500 capsule, liquid filled in 1 bag. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Docusate Sodium And Sennosides?

This product is used as Stool softenerLaxative. Relieves occasional constipation (irregularity)generally causes bowel movement in 6-12 hours

What are Docusate Sodium And Sennosides 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.
  • 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 Docusate Sodium And Sennosides UNII Codes?

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

Which are Docusate Sodium And Sennosides 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. The UNII codes for the inactive ingredients in this product are:

* Please review the disclaimer below.

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]


* Please review the disclaimer below.

Product Footnotes

[1] 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.

[2] 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.

[3] 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.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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] 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".