FDA.reportPublic FDA data

Docusate Sodium 100 mg Softgels

Manufacturer
Forreal Pharmaceuticals, LLC
Effective date
2026-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:56:46

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure13 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 of age     ask a doctor

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each softgel)

Docusate Sodium 100 mg

OTC - PURPOSE SECTION

Purpose

Stool softener

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

Do not use if you are currently 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 or 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 stool softener laxative for more than 1 week

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, 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 immediately 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

  • each capsule contains: sodium 6 mg
  • VERY LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF).
  • keep tightly closed.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: D&C Red # 33, Edible Ink, FD&C Red # 40, FD&C Yellow # 6, Gelatin, Glycerin, Polyethylene Glycol, Purified Water, Sorbitol Special, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? (877) 367-3250

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81877-840-90

Forreal Pharmaceuticals LLC
YOUR SOLUTION TO BETTER HEALTHCARE.

Docusate
Sodium

Stool Softener

100 mg

90 Softgels

TAMPER EVIDENT: DO NOT USE IF SEAL IS BROKEN OR MISSING FROM BOTTLE.

Marketed By:
Forreal Pharmaceuticals, LLC
Royal Oak MI 48067
Questions or inquiries call
877-367-3250

Label ImageLabel Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN1
1115005docusate sodium 100 MG Oral CapsuleSCD1
1115005DOSS Sodium 100 MG Oral CapsuleSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00381877840907(21)E20D41000001(17)220331(10)E20D41GTIN-14: 00381877840907
GTIN-12: 381877840907
UPC-A: 381877840907
EAN-13: 0381877840907
GTIN storage (14 digits): 00381877840907		docusatesodium-01.jpg

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
81877-840-90Docusate Sodium90 in 1 BOTTLECAPSULE901

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81877-84081877-840-90

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
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
Docusate SodiumDOCUSATE SODIUMForreal Pharmaceuticals, LLC118dccb7-5df2-432d-b7d3-37b3f1ade0aa2026-05-07WarningsExact identifier
ndc (package): 81877-840-90
ndc (product): 81877-840
ndc11 (package): 81877084090
spl id: 1f9a03ed-9dd2-4868-aba2-02b97d55d0e0
spl set id: 118dccb7-5df2-432d-b7d3-37b3f1ade0aa

Reported adverse events (FAERS/openFDA)#

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