FDA.reportPublic FDA data

Stool Softener Laxative

Manufacturer
TOP CARE (Topco Associates LLC)
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:31:42

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 toll free 1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO COLACE® REGULAR STRENGTH STOOL SOFTENER ACTIVE INGREDIENT†

Stool Softener

DOCUSATE SODIUM 100 mg

STOOL SOFTENER LAXATIVE

  • Gentle
  • Effective
  • Relieves Constipation
  • Stimulant-free

SOFTGELS

†This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., distributor of Colace® Regular Strength Stool Softener.

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143

QUESTIONS? 1-888-423-0139

topcare@topco.com

www.topcarebrand.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Top Care Stool Softener
Top Care Stool Softener

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800084629GTIN-13: 0036800084629
EAN-13: 0036800084629
GTIN-12: 036800084629
UPC-A: 036800084629
GTIN storage (14 digits): 00036800084629		docusate-sodium-2-tone-100-mg-softgels-pur-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-638-10Stool Softener Laxative1 in 1 BOXCAPSULE, LIQUID FILLED16
36800-638-10Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1006
36800-638-25Stool Softener Laxative250 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2506
36800-638-60Stool Softener Laxative1 in 1 BOXCAPSULE, LIQUID FILLED16
36800-638-60Stool Softener Laxative60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED606

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
36800-63836800-638-25, 36800-638-60, 36800-638-10

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ALCOHOL3K9958V90MIACT
AMMONIA5138Q19F1XIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MINERAL OILT5L8T28FGPIACT
BUTYL ALCOHOL8PJ61P6TS3IACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
ISOPROPYL ALCOHOLND2M416302IACT

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
Stool Softener LaxativeDOCUSATE SODIUMTOP CARE (Topco Associates LLC)44fe6ce0-5fed-418f-8a6a-d6132e2883282026-01-07WarningsExact identifier
ndc (package): 36800-638-60
ndc (package): 36800-638-25
ndc (package): 36800-638-10
ndc (product): 36800-638
ndc11 (package): 36800063825
ndc11 (package): 36800063810
ndc11 (package): 36800063860
spl id: 9fc25696-b92e-4f93-b5d1-9bc08177e9fb
spl set id: 44fe6ce0-5fed-418f-8a6a-d6132e288328

Reported adverse events (FAERS/openFDA)#

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