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: Bryant Ranch Prepack
Product type: HUMAN OTC DRUG
SPL set ID: 1f11cf85-b094-4ca4-8b48-2d3a9093304b
SPL ID: 98bdddeb-53ee-4383-9a6f-d60d4082f450
Version: 3
Effective date: 2024-04-04
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:51:50

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 · 19 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		Bryant Ranch Prepack	openfda.manufacturer_name
ndc	package	71335-1677-5	openfda.package_ndc
ndc	package	71335-1677-4	openfda.package_ndc
ndc	package	71335-1677-3	openfda.package_ndc
ndc	package	71335-1677-1	openfda.package_ndc
ndc	package	71335-1677-2	openfda.package_ndc
ndc	product	71335-1677	openfda.product_ndc
ndc11	package	71335167701	derived:openfda.package_ndc
ndc11	package	71335167703	derived:openfda.package_ndc
ndc11	package	71335167702	derived:openfda.package_ndc
ndc11	package	71335167704	derived:openfda.package_ndc
ndc11	package	71335167705	derived:openfda.package_ndc
rxcui		1245468	openfda.rxcui
spl id		98bdddeb-53ee-4383-9a6f-d60d4082f450	id
spl set id		1f11cf85-b094-4ca4-8b48-2d3a9093304b	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 have a sudden change in bowel habits that persists over a period of 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.