Stool Softener Laxative

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 Laxative
Generic name: DOCUSATE SODIUM
Manufacturer: Major Pharmaceuticals
Product type: HUMAN OTC DRUG
SPL set ID: 97561cd4-63d9-44c2-a3a3-ec668a09a4ed
SPL ID: 9106599b-ff0f-4d97-a4e4-ce9ca098e23c
Version: 9
Effective date: 2025-10-31
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:27:28

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 Laxative	openfda.brand_name
generic name		DOCUSATE SODIUM	openfda.generic_name
manufacturer name		Major Pharmaceuticals	openfda.manufacturer_name
ndc	package	0904-7280-60	openfda.package_ndc
ndc	package	0904-7280-80	openfda.package_ndc
ndc	product	0904-7280	openfda.product_ndc
ndc11	package	00904728060	derived:openfda.package_ndc
ndc11	package	00904728080	derived:openfda.package_ndc
rxcui		1115005	openfda.rxcui
spl id		9106599b-ff0f-4d97-a4e4-ce9ca098e23c	id
spl set id		97561cd4-63d9-44c2-a3a3-ec668a09a4ed	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 care professional before use. Keep out of reach of children. In case of 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.