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: Reliable 1 Laboratories LLC
Product type: HUMAN OTC DRUG
SPL set ID: 44fae161-3fc8-64c4-e063-6294a90a1d26
SPL ID: 44fae16b-d2fe-bf32-e063-6394a90a74b1
Version: 1
Effective date: 2025-12-02
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:15:52

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		Reliable 1 Laboratories LLC	openfda.manufacturer_name
ndc	package	69618-086-01	openfda.package_ndc
ndc	product	69618-086	openfda.product_ndc
ndc11	package	69618008601	derived:openfda.package_ndc
rxcui		1115005	openfda.rxcui
spl id		44fae16b-d2fe-bf32-e063-6394a90a74b1	id
spl set id		44fae161-3fc8-64c4-e063-6294a90a1d26	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 • noticed a sudden change in bowel habits that lasts for over 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.