FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
Northwind Pharmaceuticals
Effective date
2015-03-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:01

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure9 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

Tamper Evident: do not use if safety seal under cap is broken or missing each capsule contains: sodium 6 mg VERY LOW SODIUM store at 25°C (77°F); excursions permitted between 15 o -30 o C (59 o -86 o F). Keep tightly closed. This Package for Households Without Young Children 

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

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

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 stool softener 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 right away (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 agetake 1 softgel daily
children under 2 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Tamper Evident: do not use if safety seal under cap is broken or missing
  • each capsule contains: sodium 6 mg
  • VERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15 o-30 oC (59 o-86 oF).

Keep tightly closed.

This Package for Households Without Young Children 

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red #33,Edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide 

Questions?

OTC - QUESTIONS SECTION

Adverse drug event call: (800) 722-0772 Mon- Fri 8 AM to 5 PM

* This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.

Package Label.Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

51655-342-2051655-342-20

NDC: 51655-342-20

MFG: 66424-399-10

Docusate Sodium 100 MG

20 Capsules

OTC

Lot#:

Exp. Date:

Each tablet contains 100 mg docusate sodium and 6 mg of sodium

Dosage: See prescriber's instructions

Store between 59-86 degrees F. Protect from light & moisture.

Keep out of the reach of children.

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Dist. by: SDA Laboratories, Inc Greenwich, CT 06830 Lot#:

Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

51655-342-5251655-342-52

NDC: 51655-342-52

MFG: 66424-399-10

Docusate Sodium 100 MG

30 Capsules

OTC

Lot#:

Exp. Date:

Each tablet contains 100 mg docusate sodium and 6 mg of sodium

Dosage: See prescriber's instructions

Store between 59-86 degrees F. Protect from light & moisture.

Keep out of the reach of children.

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Dist. by: SDA Laboratories, Inc Greenwich, CT 06830 Lot#:

Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

51655-342-2551655-342-25

NDC: 51655-342-25

MFG: 66424-030-10

Docusate Sodium 100 MG

60 Capsules

OTC

Lot#:

Exp. Date:

Each tablet contains 100 mg docusate sodium and 6 mg of sodium

Dosage: See prescriber's instructions

Store between 59-86 degrees F. Protect from light & moisture.

Keep out of the reach of children.

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Dist. by: SDA Laboratories, Inc Greenwich, CT 06830 Lot#:

Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-342-202021-01-29C16284748780-1ba0f9c33-4e9b-a910-e053-dadaa90a0b85Docusate Sodium 100mg
51655-342-522021-01-29C16284748780-1ba0f9c33-4e9b-a910-e053-dadaa90a0b85Docusate Sodium 100mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-342-20Docusate Sodium20 in 1 BOTTLECAPSULE, LIQUID FILLED201
51655-342-52Docusate Sodium30 in 1 BOTTLECAPSULE, LIQUID FILLED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-342DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NORTHWIND PHARMACEUTICALS]1Legacy NDC, 2 package rows20190329_82fab9f8-fdf2-fd32-e053-2a91aa0af596.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66424-399-01EA - Each66424-399f1c0f5ec-a9ad-4875-83ce-23a6c9fe620612017-03-06
66424-399-10EA - Each66424-39960208ae9-93b5-45a0-99d0-d87eb336378512017-03-06

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
51655-34251655-342-20, 51655-342-52
66424-399

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
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
82fb2524-1ae9-3c80-e053-2991aa0a121982fab9f8-fdf2-fd32-e053-2a91aa0af5962015-03-02WarningsExact identifier
spl id: 82fb2524-1ae9-3c80-e053-2991aa0a1219
spl set id: 82fab9f8-fdf2-fd32-e053-2a91aa0af596

Reported adverse events (FAERS/openFDA)#

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