Stool Softener

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Stool Softener
Generic name: DOCUSATE SODIUM
Manufacturer: Geri-Care Pharmaceutical Corp
Product type: HUMAN OTC DRUG
SPL set ID: b595063a-5fee-18c2-e053-2a95a90a5b99
SPL ID: 0a34593a-4c33-3ddd-e063-6394a90a58c1
Version: 4
Effective date: 2023-11-15
Source export date: 2026-10-12
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:26:52

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M007	openfda.application_number
brand name		Stool Softener	openfda.brand_name
generic name		DOCUSATE SODIUM	openfda.generic_name
manufacturer name		Geri-Care Pharmaceutical Corp	openfda.manufacturer_name
ndc	package	57896-426-01	openfda.package_ndc
ndc	product	57896-426	openfda.product_ndc
ndc11	package	57896042601	derived:openfda.package_ndc
rxcui		1245468	openfda.rxcui
spl id		0a34593a-4c33-3ddd-e063-6394a90a58c1	id
spl set id		b595063a-5fee-18c2-e053-2a95a90a5b99	set_id
unii		F05Q2T2JA0	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings 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.

Reported adverse events (FAERS/openFDA)#

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