FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
PHARMAMED USA INC | PHARBEST PHARMACEUTICALS, INC.
Effective date
2024-06-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:17

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 ask a doctor

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

OTHER SAFETY INFORMATION

  • 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARMAMED

NDC 84289-399-01

Manufactured in the U.S.A

Docusate

Sodium

100 softgels

100mg each

*Compare to the active ingredient of Colace*

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

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

Label ImageLabel Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN2
1115005docusate sodium 100 MG Oral CapsuleSCD2
1115005DOSS Sodium 100 MG Oral CapsuleSY2

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
84289-399-01Docusate Sodium100 in 1 BOTTLECAPSULE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84289-399DOCUSATE SODIUM (DOCUSATE SODIUM 100MG) CAPSULE [PHARMAMED USA INC]21 package rows20241001_1b2f2afd-1e8a-058c-e063-6294a90a24ff.zip

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
84289-39984289-399-01
16103-399

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
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
GLYCERINPDC6A3C0OXIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
GELATIN, UNSPECIFIED2G86QN327LIACT

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 SODIUM 100MGPharbest Pharmaceuticals, Inc.025e03e0-e273-47ed-87f7-98e388abe0472026-03-05WarningsExact identifier
ndc (product): 16103-399
1bce0f91-2023-8cad-e063-6394a90a46141b2f2afd-1e8a-058c-e063-6294a90a24ff2024-06-26WarningsExact identifier
spl id: 1bce0f91-2023-8cad-e063-6394a90a4614
spl set id: 1b2f2afd-1e8a-058c-e063-6294a90a24ff

Reported adverse events (FAERS/openFDA)#

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