FDA.reportPublic FDA data

Docusate Sodium 100 mg Softgels

Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2026-06-12
Label type
HUMAN OTC DRUG LABEL
Version
20
Source
daily-update
Hydrated at
2026-06-16 05:10:08

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 SEAL IS BROKEN OR MISSING FROM BOTTLE. 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

  • TAMPER EVIDENT: DO NOT USE IF SEAL IS BROKEN OR MISSING FROM BOTTLE.
  • each softgel contains: sodium 6 mg
  • VERY LOW SODIUM
  • store at 25 oC (77 oF); excursions permitted between 15 o-30 oC (59 o-86 oF).

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

Docusate

Sodium

100 mg each

55289493 Label55289493 Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00355289493143(21)L22C76000001(17)240731(10)L22C76GTIN-14: 00355289493143
GTIN-12: 355289493143
UPC-A: 355289493143
EAN-13: 0355289493143
GTIN storage (14 digits): 00355289493143		55289493.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-493-01EA - Each55289-4933c49bdc5-bd16-4d64-91f8-2678df40de7212023-06-06
55289-493-12EA - Each55289-49323f7085f-daef-48e6-87f0-8403f94df9b412021-05-05
55289-493-14EA - Each55289-493b613e57f-640f-4f63-a125-120bb2247d6d12018-04-19
55289-493-30EA - Each55289-4934f9252c6-8cec-468c-8398-30f72580f94712018-04-19
55289-493-60EA - Each55289-493079ae045-5df5-4b00-a74c-90e64c52be1e12018-04-19
55289-493-90EA - Each55289-493c575b1bb-c86e-436f-9610-e24584257f6412018-04-19
55289-493-93EA - Each55289-493b3bfe6d0-cc05-415c-aa3a-e7179ecec52e12017-12-14
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 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55289-49355289-493-12, 55289-493-14, 55289-493-30, 55289-493-60, 55289-493-90, 55289-493-93, 55289-493-01
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
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
DOCUSATE SODIUMF05Q2T2JA0ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
192025-10-20full-release2026-06-01 01:39:37
182024-03-12full-release2026-06-01 00:09:41

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.66ca7a94-378b-4476-8060-d9c6f82f57fc2026-06-12WarningsExact identifier
ndc (package): 55289-493-93
ndc (package): 55289-493-14
ndc (package): 55289-493-60
ndc (package): 55289-493-12
ndc (package): 55289-493-01
ndc (package): 55289-493-30
ndc (package): 55289-493-90
ndc (product): 55289-493
ndc11 (package): 55289049301
ndc11 (package): 55289049390
ndc11 (package): 55289049312
ndc11 (package): 55289049330
ndc11 (package): 55289049360
ndc11 (package): 55289049314
ndc11 (package): 55289049393
spl id: 54129d13-ffb2-2e6d-e063-6394a90a6290
spl set id: 66ca7a94-378b-4476-8060-d9c6f82f57fc
Docusate SodiumDOCUSATE SODIUM 100MGPharbest Pharmaceuticals, Inc.025e03e0-e273-47ed-87f7-98e388abe0472026-03-05WarningsExact identifier
ndc (product): 16103-399

Reported adverse events (FAERS/openFDA)#

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