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Docusate Sodium

Drug Facts

Approved
Approval ID

d729ceac-2eef-40c0-bb1a-f8d80290c60f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Good Sense (Geiss, Destin & Dunn, Inc.)

DUNS: 076059836

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

DOCUSATE SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50804-862
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
DOCUSATE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (11)

DOCUSATE SODIUMActive
Quantity: 100 mg in 1 1
Code: F05Q2T2JA0
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

Product Label

![Docusate Sodium 100 mg](/dailymed/image.cfm?name=docusate-sodium-100-mg- single-tone-softgels-pat-de-1.jpg&id=892445)

GOOD SENSE Stool Softener

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/12/2025

Uses

  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 12 to 72 hours

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/12/2025

Questions or comments?

Call1-877-753-3935Monday-Friday 9AM-5PM EST

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/12/2025

Active ingredient (in each softgel)

Docusate Sodium 100 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/12/2025

Purpose

Stool softener laxative

WARNINGS SECTION

LOINC: 34071-1Updated: 8/12/2025

Warnings

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
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

  • you 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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/12/2025

Directions

  • take with a glass of water

adults and children 12 years and over

take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided dose

children 2 to under 12 years of age

take 1 softgel daily

children under 2 years

ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/12/2025

Other information

*each softgel contains: sodium 5 mg

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/12/2025

Inactive ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol

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Docusate Sodium - FDA Drug Approval Details