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: BJWC (Berkley & Jensen / BJ's)
Product type: HUMAN OTC DRUG
SPL set ID: 330758d2-fc1a-50ce-e063-6294a90a7db1
SPL ID: 3c12b695-d508-de0f-e063-6394a90a05dd
Version: 2
Effective date: 2025-08-19
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:42:18

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		BJWC (Berkley & Jensen / BJ's)	openfda.manufacturer_name
ndc	package	68391-730-40	openfda.package_ndc
ndc	product	68391-730	openfda.product_ndc
ndc11	package	68391073040	derived:openfda.package_ndc
rxcui		1115005	openfda.rxcui
spl id		3c12b695-d508-de0f-e063-6394a90a05dd	id
spl set id		330758d2-fc1a-50ce-e063-6294a90a7db1	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 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 stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a 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, 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 (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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