NDC 61919-525 Docusate Sodium

Docusate Sodium

NDC Product Code 61919-525

NDC Code: 61919-525

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

Color(s):
ORANGE (C48331)
Shape: OVAL (C48345)
Size(s):
12 MM
Imprint(s):
P51;S77;SCU1;D2
Score: 1

NDC Code Structure

  • 61919 - Directrx
    • 61919-525 - Docusate Sodium

NDC 61919-525-30

Package Description: 30 CAPSULE in 1 BOTTLE

NDC Product Information

Docusate Sodium with NDC 61919-525 is a a human over the counter drug product labeled by Directrx. The generic name of Docusate Sodium is docusate sodium. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Directrx

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

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.

  • FOOD YELLOW 3 FREE ACID (UNII: G2B7JWK1GG)
  • SORBITAN (UNII: 6O92ICV9RU)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SORBITOL (UNII: 506T60A25R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GELATIN (UNII: 2G86QN327L)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • WATER (UNII: 059QF0KO0R)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

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: Directrx
Labeler Code: 61919
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: 04-24-2019 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

Otc - Active Ingredient

Docusate Sodium 100 mg

Otc - Purpose

Stool softener laxative

Indications & Usage

Relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

Warnings

Do not useif you are presently taking mineral oil, unless told to do so by a doctor.Ask a doctor before use if you havestomach pain

nausea

vomiting

noticed a sudden change in bowel habits that last over 2 weeks
Stop use and ask a doctor ifyou have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be a 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.

Dosage & Administration

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 to 3 softgels daily.

children 2 to under 12 years of age take 1 softgel daily

children under 2 years ask a doctor

How Supplied

Each softgel contains: sodium 6 mg

store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredient

Edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol*contains one or more of these ingredients

Otc - Questions

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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.

* Please review the disclaimer below.

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