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: Care One (Retail Business Services, LLC.)
Product type: HUMAN OTC DRUG
SPL set ID: a1ea0993-2d23-44e3-bc72-e4bf497ab723
SPL ID: bdd95684-dbf1-42c2-8184-fa7982904fa6
Version: 2
Effective date: 2024-03-05
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:53:15

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 Laxative	openfda.brand_name
generic name		DOCUSATE SODIUM	openfda.generic_name
manufacturer name		Care One (Retail Business Services, LLC.)	openfda.manufacturer_name
ndc	package	72476-107-25	openfda.package_ndc
ndc	product	72476-107	openfda.product_ndc
ndc11	package	72476010725	derived:openfda.package_ndc
rxcui		1115005	openfda.rxcui
spl id		bdd95684-dbf1-42c2-8184-fa7982904fa6	id
spl set id		a1ea0993-2d23-44e3-bc72-e4bf497ab723	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 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 using a laxative. These could be a sign 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 (1-800-2222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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