FDA.reportPublic FDA data

Docusate Sodium, USP

Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2026-10-16
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-10-20 03:03:27

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure9 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

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 Do not use:

WARNINGS 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 pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare 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 (800) 222-1222.

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 (800) 682-9862

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate Sodium, USP
Stool Softener
250 mg Each

72789166 Label
72789166 Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00372789166605(21)B21A540004(17)220831(10)B21A54GTIN-14: 00372789166605
GTIN-12: 372789166605
UPC-A: 372789166605
EAN-13: 0372789166605
GTIN storage (14 digits): 00372789166605		72789166.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-166-60EA - Each72789-166831364a0-d189-4b90-bf1c-513dd8b58e4f12021-04-08
54629-601-01EA - Each54629-601e245c595-3a46-46e1-9d19-668930bf45bd12013-02-13
54629-601-99EA - Each54629-601097fce90-d965-4325-ad79-a72f0644601b12013-02-13

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
72789-16672789-166-60
54629-601

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-02-05full-release2026-06-01 00:54:29

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.6a7e4193-22d2-491e-9842-5c43f571fc652025-02-05WarningsExact identifier
ndc (package): 72789-166-60
ndc (product): 72789-166
ndc11 (package): 72789016660
spl set id: 6a7e4193-22d2-491e-9842-5c43f571fc65
Docusate SodiumDOCUSATE SODIUMNational Vitamin Company0c66642c-82cb-42cd-82bb-5f95852cc5d12024-12-12WarningsExact identifier
ndc (product): 54629-601

Reported adverse events (FAERS/openFDA)#

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