FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
Direct_Rx
Effective date
2022-09-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:54:36

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure9 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• have a sudden change in bowel habits that persists over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement. These

could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

OTC - PURPOSE SECTION

Stool Softener Laxative

INDICATIONS & USAGE SECTION

relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

each softgel contains: sodium 7 mg. Very low sodium

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72189-377-3072189-377-30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72189-377-6072189-377-60

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-377-30EA - Each72189-3770ac5f2e0-7654-4402-8c36-88e876e0723512022-09-12
72189-377-60EA - Each72189-3774b3b7bee-e25e-47e7-8959-f229f8b517ae12022-10-06
57896-401-01EA - Each57896-401da8e6844-b6ae-4244-8bfc-f7ad99d8eaf812013-06-04
57896-401-03EA - Each57896-4016762957d-d7f6-4213-a664-2c7f42fc9f3612013-06-04
57896-401-10EA - Each57896-4017ae1d03c-6162-4398-b8d2-1946db28e94112013-06-04
57896-401-20EA - Each57896-4018f701acd-94d7-43d2-9072-f8fbf72510af12021-02-05
57896-401-25EA - Each57896-4015c82cab7-f225-43ff-b3f5-38f5ffd4b01a12018-11-06

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
72189-37772189-377-30, 72189-377-60
57896-401

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
POLYETHYLENE GLYCOL 400B697894SGQIACT
GELATIN2G86QN327LIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MANNITOL3OWL53L36AIACT

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
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp644d81ec-d38f-4172-a087-727b94e2fefe2023-10-19WarningsExact identifier
ndc (product): 57896-401
07d9b739-eacf-d06a-e063-6294a90a7413e78dceed-6b04-275a-e053-2a95a90a59bf2023-10-16WarningsExact identifier
spl set id: e78dceed-6b04-275a-e053-2a95a90a59bf

Reported adverse events (FAERS/openFDA)#

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