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, SENNOSIDES
Manufacturer: Family Dollar (FAMILY WELLNESS)
Product type: HUMAN OTC DRUG
SPL set ID: 1eee3ed5-09f7-44a9-abc5-98336e493fe8
SPL ID: 1dc35b90-2641-4168-a801-212005aef90a
Version: 6
Effective date: 2025-10-30
Source export date: 2026-10-12
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:45:01

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		505G(a)(3)	openfda.application_number
brand name		Stool Softener Laxative	openfda.brand_name
generic name		DOCUSATE SODIUM, SENNOSIDES	openfda.generic_name
manufacturer name		Family Dollar (FAMILY WELLNESS)	openfda.manufacturer_name
ndc	package	55319-565-10	openfda.package_ndc
ndc	product	55319-565	openfda.product_ndc
ndc11	package	55319056510	derived:openfda.package_ndc
rxcui		998740	openfda.rxcui
spl id		1dc35b90-2641-4168-a801-212005aef90a	id
spl set id		1eee3ed5-09f7-44a9-abc5-98336e493fe8	set_id
unii		3FYP5M0IJX	openfda.unii
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 laxative products for longer than 1 week unless directed by a doctor 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 a period of 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. 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.