NDC 55910-223 Docusate Sodium

Docusate Sodium

NDC Product Code 55910-223

NDC CODE: 55910-223

Proprietary Name: Docusate Sodium 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.

Non-Proprietary Name: Docusate Sodium 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.

Product Characteristics

Shape: OVAL (C48345)
12 MM
Score: 1

NDC Code Structure

  • 55910 - Dolgencorp, Inc.

NDC 55910-223-10

Package Description: 1 BOTTLE in 1 CARTON > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC Product Information

Docusate Sodium with NDC 55910-223 is a a human over the counter drug product labeled by Dolgencorp, Inc.. The generic name of Docusate Sodium is docusate sodium. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Dolgencorp, Inc.

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.

Product Type: Human Otc Drug 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.

Docusate Sodium Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DOCUSATE SODIUM 100 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • GELATIN (UNII: 2G86QN327L)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Dolgencorp, Inc.
Labeler Code: 55910
FDA Application Number: part334 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 05-21-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Stool Softeners

Stool Softeners is

Why is stool softeners medication prescribed?
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, hemorrhoid...
[Read More]

* Please review the disclaimer below.

Docusate Sodium Product Label Images

Docusate Sodium Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index


Drug Facts

Active Ingredient (In Each Softgel)

Docusate Sodium 100 mg


Stool Softner


  • Relieves occasional constipation (irregularity)this product generally produces a bowel movement within 12 to 72 hours



Do Not Use

  • If you are presently taking mineral oil, unless told to do so by a doctor

Ask A Doctor Before Use If You Have

  • Stomach pain nauseavomittionga sudden change in bowel habits that lasts more than 2 weeks

Stop Use And Ask A Doctor If

  • you have rectal bleeding ot no bowel movement after use of a laxative. These could be signs of a serious condition.yo need to use a stool softener laxative for more than 1 week

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. 
In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222


Take only by mouth. Doses may be taken as a single daily dose or in divided doses.Adults and children 12 years and over : take 1-3 softgels daily.Children 2 to under 12 years of age : 
take 1 softgel daily.Children under 2 years of age: ask a doctor

Other Information

  • Store at 25°C  (77°F), excursions permitted between 15°-30°C (59°-86°F)Keep tightly closed.

Inactive Ingredients

Gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution, titanium dioxide.

* Please review the disclaimer below.