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: Allegiant Health
Product type: HUMAN OTC DRUG
SPL set ID: 9fbe783e-ddd9-445a-852a-00f4ad754880
SPL ID: c35dda2c-6127-4f02-9ae2-330b7a22a973
Version: 6
Effective date: 2021-04-20
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:17:47

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 · 13 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		Allegiant Health	openfda.manufacturer_name
ndc	package	69168-424-81	openfda.package_ndc
ndc	package	69168-424-32	openfda.package_ndc
ndc	product	69168-424	openfda.product_ndc
ndc11	package	69168042481	derived:openfda.package_ndc
ndc11	package	69168042432	derived:openfda.package_ndc
rxcui		1115005	openfda.rxcui
spl id		c35dda2c-6127-4f02-9ae2-330b7a22a973	id
spl set id		9fbe783e-ddd9-445a-852a-00f4ad754880	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 stomach pain nausea vomiting notice a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. you need a laxative for more than 1 week Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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