FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
Pharbest Pharmaceuticals, Inc. | Pharbest Pharmaceuticals, Inc | SWISSCAPS Romania srl
Effective date
2026-03-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:49:02

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

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

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 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 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

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

keep tightly closed.

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 or comments?

OTC - QUESTIONS SECTION

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 16103-0399-11

*Compare to the active ingredient of Colace®

Docusate

Sodium

Stool Softener

1000 SOFTGELS

100 mg each

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

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

Docusate Sodium 100 mg Softgels Package LabelDocusate Sodium 100 mg Softgels Package Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN3
1115005docusate sodium 100 MG Oral CapsuleSCD3
1115005DOSS Sodium 100 MG Oral CapsuleSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
16103-399-082026-01-29C16284748780-1d6a99b39-9e61-a426-e053-dadaa90af4c2Docusate Sodium 100 mg Softgels
16103-399-112026-01-29C16284748780-1d6a99b39-9e61-a426-e053-dadaa90af4c2Docusate Sodium 100 mg Softgels
16103-399-082024-01-19C16284748780-1d6a99b39-9e61-a426-e053-dadaa90af4c2Docusate Sodium 100 mg Softgels
16103-399-112024-01-19C16284748780-1d6a99b39-9e61-a426-e053-dadaa90af4c2Docusate Sodium 100 mg Softgels
16103-399-082022-01-28C16284748780-1d6a99b39-9e61-a426-e053-dadaa90af4c2Docusate Sodium 100 mg Softgels
16103-399-112022-01-28C16284748780-1d6a99b39-9e61-a426-e053-dadaa90af4c2Docusate Sodium 100 mg Softgels

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-399-08Docusate Sodium100 in 1 BOTTLECAPSULE1003
16103-399-11Docusate Sodium1000 in 1 BOTTLECAPSULE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-399-08EA - Each16103-399463d6a62-9936-4856-91dd-fe23717ceae512019-04-11
16103-399-11EA - Each16103-3990cad9fe1-9128-4221-bb7b-c73e708258bb12019-04-11

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
16103-39916103-399-08, 16103-399-11

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 · Source PDF

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 SODIUM 100MGPharbest Pharmaceuticals, Inc.025e03e0-e273-47ed-87f7-98e388abe0472026-03-05WarningsExact identifier
ndc (package): 16103-399-11
ndc (package): 16103-399-08
ndc (product): 16103-399
ndc11 (package): 16103039911
ndc11 (package): 16103039908
spl id: 43b71fc6-6af3-4f45-a946-ab9cff49f5ba
spl set id: 025e03e0-e273-47ed-87f7-98e388abe047

Reported adverse events (FAERS/openFDA)#

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