FDA.reportPublic FDA data

Stool Softener Laxative

Manufacturer
Walgreens
Effective date
2026-03-10
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:49:45

Label at a glance#

ProductStool Softener Laxative
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement in 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  ask a doctor 

Storage and handling

each softgel contains : sodium 5 mg store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • 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 told to do so by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs 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 only by mouth. Doses may be taken as a single daily dose or in divided doses
adults and children 12 years and overtake 1-3 softgels daily 
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 5 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, anhydrous citric acid, D&C red #33, ethyl alcohol, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mineral oil, n-butyl alcohol, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Colace® Regular Strength Stool Softener††

Stool Softener

DOCUSATE SODIUM 100 mg /

STOOL SOFTENER LAXATIVE

Regular Strength

  • Relief of occasional constipation
  • Gentle & effective 
  • Stimulant free

SOFTGELS

††This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., owner of the registered trademark Colace®.

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: WALGREEN CO.

DEERFIELD, IL 60015

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WALGREENS Regular Strength Stool Softener
WALGREENS Regular Strength Stool Softener

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN8
1115005docusate sodium 100 MG Oral CapsuleSCD8
1115005DOSS Sodium 100 MG Oral CapsuleSY8

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130311917026008GTIN-13: 0311917026008
EAN-13: 0311917026008
GTIN-12: 311917026008
UPC-A: 311917026008
GTIN storage (14 digits): 00311917026008		docusate-sodium-2-tone-softgels-pur-100-mg-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-4100-20Stool Softener Laxative200 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2008
0363-4100-40Stool Softener Laxative400 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED4008
0363-4100-60Stool Softener Laxative1 in 1 BOXCAPSULE, LIQUID FILLED18
0363-4100-60Stool Softener Laxative60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-4100-40EA - Each0363-410080e6ceb4-bbdf-4dd4-bef6-991983e510ac12023-04-07

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-41000363-4100-60, 0363-4100-40, 0363-4100-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
AMMONIA5138Q19F1XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ALCOHOL3K9958V90MIACT
ISOPROPYL ALCOHOLND2M416302IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MINERAL OILT5L8T28FGPIACT
BUTYL ALCOHOL8PJ61P6TS3IACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72026-01-06monthly-update2026-06-03 17:51:27
62025-12-18monthly-update2026-06-03 17:46:13

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
Stool Softener LaxativeDOCUSATE SODIUMWalgreens92df761b-da68-4ce9-b02a-a5a74fd6620e2026-03-10WarningsExact identifier
ndc (package): 0363-4100-40
ndc (package): 0363-4100-20
ndc (package): 0363-4100-60
ndc (product): 0363-4100
ndc11 (package): 00363410060
ndc11 (package): 00363410020
ndc11 (package): 00363410040
spl id: dba5a864-8145-44a3-8c89-42870b53ad19
spl set id: 92df761b-da68-4ce9-b02a-a5a74fd6620e

Reported adverse events (FAERS/openFDA)#

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