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: Proficient Rx LP
Product type: HUMAN OTC DRUG
SPL set ID: f9ac0344-5864-4ac1-81bc-16878a5946c5
SPL ID: 5c0507c4-d04d-4453-b688-fa1d856f751d
Version: 4
Effective date: 2024-02-01
Source export date: 2026-10-12
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:43:51

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 · 17 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		Proficient Rx LP	openfda.manufacturer_name
ndc	package	63187-476-90	openfda.package_ndc
ndc	package	63187-476-30	openfda.package_ndc
ndc	package	63187-476-60	openfda.package_ndc
ndc	package	63187-476-00	openfda.package_ndc
ndc	product	63187-476	openfda.product_ndc
ndc11	package	63187047630	derived:openfda.package_ndc
ndc11	package	63187047660	derived:openfda.package_ndc
ndc11	package	63187047690	derived:openfda.package_ndc
ndc11	package	63187047600	derived:openfda.package_ndc
rxcui		1115005	openfda.rxcui
spl id		5c0507c4-d04d-4453-b688-fa1d856f751d	id
spl set id		f9ac0344-5864-4ac1-81bc-16878a5946c5	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 currently taking mineral oil, unless directed by a doctor Ask a doctor before use if you have • stomach pain, nausea or vomiting • have noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if • you have rectal bleeding • you fail to have a bowel movement after use • 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. 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.