FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2026-02-26
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:47:50

Label at a glance#

ProductDOCUSATE SODIUM
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 7 mg store at 25ºC (77ºF); excursion 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

SPL UNCLASSIFIED 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 stool softener laxative for more than 1 week

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care 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 agetake 1 softgel daily
children under 2 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

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

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

docusate sodium 100 mg

stool softener laxative

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

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72789399 Label
72789399 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN10
1115005docusate sodium 100 MG Oral CapsuleSCD10
1115005DOSS Sodium 100 MG Oral CapsuleSY10

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00372789399607(21)L22B69000006(17)240731(10)L22B69GTIN-14: 00372789399607
GTIN-12: 372789399607
UPC-A: 372789399607
EAN-13: 0372789399607
GTIN storage (14 digits): 00372789399607		72789399.jpg
BarcodeEAN-130372789399607GTIN-13: 0372789399607
EAN-13: 0372789399607
GTIN-12: 372789399607
UPC-A: 372789399607
GTIN storage (14 digits): 00372789399607		72789399.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-399-30DOCUSATE SODIUM30 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED3010
72789-399-60DOCUSATE SODIUM60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-399-30EA - Each72789-39977c21720-fba0-4b6f-a811-32aad7aa05fb12024-07-12
72789-399-60EA - Each72789-399e1a46600-2c4f-4e61-a38d-4dba838a881112024-06-10
0904-7280-60EA - Each0904-728026a1e584-5c99-4037-9a6b-ca3b57d707f212023-03-13
0904-7280-80EA - Each0904-7280d88438cf-e71a-4f39-b013-ee79652343c412023-03-13

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
72789-39972789-399-30, 72789-399-60
0904-7280

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SORBITAN6O92ICV9RUIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCUSATE SODIUMDOCUSATE SODIUMPD-Rx Pharmaceuticals, Inc.5d300ea7-78eb-4e19-8333-1e42c73c4c542026-02-26WarningsExact identifier
ndc (package): 72789-399-60
ndc (package): 72789-399-30
ndc (product): 72789-399
ndc11 (package): 72789039930
ndc11 (package): 72789039960
spl id: 4bc0d603-ca55-d405-e063-6394a90a1ac7
spl set id: 5d300ea7-78eb-4e19-8333-1e42c73c4c54
Stool Softener LaxativeDOCUSATE SODIUMMajor Pharmaceuticals97561cd4-63d9-44c2-a3a3-ec668a09a4ed2025-10-31WarningsExact identifier
ndc (product): 0904-7280

Reported adverse events (FAERS/openFDA)#

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