Docusate Sodium

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
Generic name: DOCUSATE SODIUM
Manufacturer: Asclemed USA, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 30fc8c07-c26b-4bcc-a727-6e193f5727fd
SPL ID: 07cec8ef-ecca-ac49-e063-6294a90a6083
Version: 2
Effective date: 2023-10-16
Source export date: 2026-10-27
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/2026-10-27/2eee27992d1f29d82f827fd5be42f1314ed39ce4c497af5d81435ac6656a0957/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:21:54

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M007	openfda.application_number
brand name		Docusate Sodium	openfda.brand_name
generic name		DOCUSATE SODIUM	openfda.generic_name
manufacturer name		Asclemed USA, Inc.	openfda.manufacturer_name
ndc	package	76420-225-30	openfda.package_ndc
ndc	package	76420-225-90	openfda.package_ndc
ndc	package	76420-225-60	openfda.package_ndc
ndc	product	76420-225	openfda.product_ndc
ndc11	package	76420022590	derived:openfda.package_ndc
ndc11	package	76420022560	derived:openfda.package_ndc
ndc11	package	76420022530	derived:openfda.package_ndc
rxcui		1115005	openfda.rxcui
spl id		07cec8ef-ecca-ac49-e063-6294a90a6083	id
spl set id		30fc8c07-c26b-4bcc-a727-6e193f5727fd	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.