FDA.reportPublic FDA data

Docusate Sodium, USP

Manufacturer
Cardinal Health 107, LLC
Effective date
2026-04-23
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:55:15

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure14 sections

Indications and uses

• For the relief of occasional constipation. • Helps to prevent dry, hard stools. • This product generally produces a bowel movement within 12 to 72 hours.

Dosage and administration

Adults and Children over 12 years of age Take orally 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor. Children under 12 years of age Do not use this product for children under 12 years of age, unless directed by a doctor.

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 250 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener

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 right away.

Uses

INDICATIONS & USAGE SECTION

  • For the relief of occasional constipation.
  • Helps to prevent dry, hard stools.
  • This product generally produces a bowel movement within 12 to 72 hours.

Warnings

WARNINGS SECTION

Do not use:

OTC - DO NOT USE SECTION

  • If you are currently taking mineral oil, unless directed by a doctor.
  • When abdominal pain, nausea, or vomiting are present.
  • For longer than one week unless directed by a doctor.

Ask a doctor before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if you notice a sudden change in bowel habits that persists over a period of two weeks.

Stop use and ask a doctor

OTC - STOP USE SECTION

if you have rectal bleeding or you fail to have a bowel movement after use.

If you are pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children over 12 years of age

Take orally 1 softgel preferably at bedtime for
2-3 days or until bowel movements are normal, or as directed by a doctor.

Children under 12 years of age

Do not use this product for children under 12 years of age, unless directed by a doctor.

Other Information

SPL UNCLASSIFIED SECTION

  • Each softgel contains 13 mg of Sodium.                    
  • Store at room temperature between 15°C to 30°C (59°F to 86°F).
  • Do not use if printed seal under cap is broken or missing.
  • For identification purposes, each softgel will have an imprint that reads NV12.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol

Questions

OTC - QUESTIONS SECTION

Call 1-855-361-3993

.

SPL UNCLASSIFIED SECTION

Overbagged with 10 softgels per bag, NDC 55154-4341-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478

USA

Distributed By:

Cardinal Health

Dublin, OH 43017

L5365630-10724 / L5365630-20724

AV Rev. 05/16 (P)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55154-4341-0

DOCUSATE SODIUM, USP 250 mg

STOOL SOFTENER

10 SOFTGELS

250mg bag label
250mg bag label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245468docusate sodium 250 MG Oral CapsulePSN7
1245468docusate sodium 250 MG Oral CapsuleSCD7
1245468DOSS Sodium 250 MG Oral CapsuleSY7

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130055154434102GTIN-13: 0055154434102
EAN-13: 0055154434102
GTIN-12: 055154434102
UPC-A: 055154434102
GTIN storage (14 digits): 00055154434102		2b49133c-a8b5-b411-e063-6294a90a3600-00.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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55154-4341-02021-08-27C16284748780-1ba0f9c33-1c22-a910-e053-dadaa90a0b85Docusate Sodium, USP Stool Softener
55154-4341-02021-01-29C16284748780-1ba0f9c33-1c22-a910-e053-dadaa90a0b85Docusate Sodium, USP Stool Softener

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-4341-0Docusate Sodium1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED17
55154-4341-0Docusate Sodium10 in 1 BAGCAPSULE, LIQUID FILLED107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-268-11EA - Each50268-2687d3c677d-a74e-49e9-8f06-b86a12b30cba12017-06-15
50268-268-15EA - Each50268-268a0ad7a2e-1947-4f96-84ed-ef379e21f6bd12017-06-15

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55154-434155154-4341-0
50268-268

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT

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
165ae794-96f7-4594-baea-7ea53e8331e02e92ab21-6e5f-4c85-85f9-931d2d573e052026-04-23WarningsExact identifier
spl id: 165ae794-96f7-4594-baea-7ea53e8331e0
spl set id: 2e92ab21-6e5f-4c85-85f9-931d2d573e05
Docusate SodiumDOCUSATE SODIUMAvPAKf31a4349-7826-45c0-9388-6b938d167b7a2025-01-09WarningsExact identifier
ndc (product): 50268-268

Reported adverse events (FAERS/openFDA)#

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