DOCUSATE SODIUM 100MG

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: DOCUSATE SODIUM 100MG
Generic name: DOCUSATE SODIUM 100MG
Manufacturer: Farmacias De Similares TX LLC
Product type: HUMAN OTC DRUG
SPL set ID: 44269b79-a5ad-f443-e063-6294a90a8473
SPL ID: 4979a97a-dd69-ee4b-e063-6294a90a9386
Version: 2
Effective date: 2026-01-28
Source export date: 2026-11-06
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 08:10:35

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		DOCUSATE SODIUM 100MG	openfda.brand_name
generic name		DOCUSATE SODIUM 100MG	openfda.generic_name
manufacturer name		Farmacias De Similares TX LLC	openfda.manufacturer_name
ndc	package	85786-502-24	openfda.package_ndc
ndc	product	85786-502	openfda.product_ndc
ndc11	package	85786050224	derived:openfda.package_ndc
rxcui		1115005	openfda.rxcui
spl id		4979a97a-dd69-ee4b-e063-6294a90a9386	id
spl set id		44269b79-a5ad-f443-e063-6294a90a8473	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 Warnings Do not use if if you are presently taking mineral oil, unless directed to 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 professional before use Keep out of reach of children. 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.