FDA.reportPublic FDA data

Stool Softener

Manufacturer
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Effective date
2024-03-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:09:50

Label at a glance#

ProductStool Softener
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

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

Dosage and administration

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 doses.  children 2 to under 12 years of age  take 1 softgel daily  children under 2 years  ask a doctor

Storage and handling

each softgel contains: sodium 7 mg store at 25ºC (77º); excursions permitted between 15-30ºC (59º-86ºF)

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium USP,  100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are presently taking mineral oil, unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain
  • nausea
  • vomiting
  • 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 or no bowel movement after using a laxative. These could be sign of a serious condition.
  • you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 doses.
 children 2 to under 12 years of age take 1 softgel daily
 children under 2 years  ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each softgel contains: sodium 7 mg
  • store at 25ºC (77º); excursions permitted between 15-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-309-9030

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredient in Dulcolax® Stool Softener**

Gentle Relief

Stool Softener

Docusate Sodium, 100 mg

Stool softener laxative

Fast, Dependable Relief of Occasional Constipation

100 mg

Softgels

**This product is not manufactured by Chattem, Inc., distributor of Dulcolax® Stool Softener.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN  37072

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOLLAR GENERAL Docusate Sodium 100 mg softgels
DOLLAR GENERAL Docusate Sodium 100 mg softgels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN2
1115005docusate sodium 100 MG Oral CapsuleSCD2
1115005DOSS Sodium 100 MG Oral CapsuleSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-938-25Stool Softener1 in 1 BOXCAPSULE, LIQUID FILLED12
55910-938-25Stool Softener25 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED252
55910-938-50Stool Softener1 in 1 BOXCAPSULE, LIQUID FILLED12
55910-938-50Stool Softener50 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-938STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]2Current NDC, Legacy NDC, 4 package rows20240316_8b033d56-b95b-4905-9f33-cf2fbd61ce35.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-93855910-938-50, 55910-938-25
53345-008

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCUSATE SODIUMDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b10fdf50-289e-41f3-9b83-a4e4dd892f882024-11-21WarningsExact identifier
ndc (product): 53345-008
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8b033d56-b95b-4905-9f33-cf2fbd61ce352024-03-15WarningsExact identifier
ndc (package): 55910-938-50
ndc (package): 55910-938-25
ndc (product): 55910-938
ndc11 (package): 55910093850
ndc11 (package): 55910093825
spl id: 229587dd-4b00-4e65-b96a-914703c3bfb0
spl set id: 8b033d56-b95b-4905-9f33-cf2fbd61ce35

Reported adverse events (FAERS/openFDA)#

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