FDA.reportPublic FDA data

DOCUSATE SODIUM

Manufacturer
Dolgencorp, Inc.
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:47:21

Label at a glance#

ProductDOCUSATE SODIUM
Active ingredientDOCUSATE SODIUM
Label structure15 sections

Indications and uses

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

Dosage and 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 1-3 softgels daily. Children 2 to under 12 years of age :  take 1 softgel daily. Children under 2 years of age: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg 

Purpose

OTC - PURPOSE SECTION

Stool Softner 

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain
  •  nausea
  • vomittiong
  • a sudden change in bowel habits that lasts more than 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-888-309-9030

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DGTM Health

Compare to the active ingredient of Colace®*

STOOL SOFTENER CLEAR

DOCUSATE SODIUM 100 mg

Relieves constipation

Gentle Relief

Stimulant-Free
Dye-Free

100 Softgels

* This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace.

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN6
1115005docusate sodium 100 MG Oral CapsuleSCD6
1115005DOSS Sodium 100 MG Oral CapsuleSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-223-10DOCUSATE SODIUM1 in 1 CARTONCAPSULE, LIQUID FILLED16
55910-223-10DOCUSATE SODIUM100 in 1 BOTTLECAPSULE, LIQUID FILLED1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-223DOCUSATE SODIUM CAPSULE, LIQUID FILLED [DOLGENCORP, INC.]6Legacy NDC, 2 package rows20241222_2b29df80-b142-474b-8139-fbfd456ae09d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-22355910-223-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
29a1deef-0e06-bebd-e063-6294a90ad4322b29df80-b142-474b-8139-fbfd456ae09d2024-12-19WarningsExact identifier
spl id: 29a1deef-0e06-bebd-e063-6294a90ad432
spl set id: 2b29df80-b142-474b-8139-fbfd456ae09d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.