0363-0827 NDC - STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES)

Drug Information

  • Product NDC: 0363-0827
  • Proprietary Name: Stool Softener Laxative
  • Non Proprietary Name: docusate sodium and sennosides
  • Active Ingredient(s): 50 mg/1 DOCUSATE SODIUM; 8.6 mg/1 SENNOSIDES
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET

Labeler Information

Field Name Field Value
Labeler Name: Walgreens
Product Type: HUMAN OTC DRUG
FDA Application Number: M007
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:9/30/2018

Package Information

No. Package Code Package Description Billing Unit
10363-0827-20200 TABLET in 1 BOTTLE, PLASTIC (0363-0827-20)
20363-0827-601 BOTTLE in 1 BOX (0363-0827-60) / 60 TABLET in 1 BOTTLEEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0363-0827The translation of the route code submitted by the firm, indicating route of administration.
PRODUCT TYPE NAMEHUMAN OTC DRUGThis is the date that the labeler indicates was the start of its marketing of the drug product.
PROPRIETARY NAMEStool Softener LaxativeProduct 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.
PROPRIETARY NAME SUFFIXPlus StimulantThis 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.
NON PROPRIETARY NAMEdocusate sodium and sennosidesName of Company corresponding to the labeler code segment of the Product NDC.
DOSAGE FORM NAMETABLETAn 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.
ROUTE NAMEORAL 
START MARKETING DATE9/30/2018 
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGProduct 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.
APPLICATION NUMBERM007This 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.
LABELER NAMEWalgreensName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDOCUSATE SODIUM; SENNOSIDESAn 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.
ACTIVE NUMERATOR STRENGTH50; 8.6 
ACTIVE INGRED UNITmg/1; mg/1 

Download Record

Download this NDC record record in Text format: Export

Download this NDC record record in Excel (CSV) format: Export

Download this NDC record record in XML format: Export

This page was last updated on: 11/21/2025

Previous Code
Next Code