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: National Vitamin Company
Product type: HUMAN OTC DRUG
SPL set ID: 0c66642c-82cb-42cd-82bb-5f95852cc5d1
SPL ID: 16a5df9c-f9e1-49dc-99cb-b21dfd97e1bf
Version: 3
Effective date: 2024-12-12
Source export date: 2026-09-28
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/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:33:22

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 · 13 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		National Vitamin Company	openfda.manufacturer_name
ndc	package	54629-601-01	openfda.package_ndc
ndc	package	54629-601-99	openfda.package_ndc
ndc	product	54629-601	openfda.product_ndc
ndc11	package	54629060199	derived:openfda.package_ndc
ndc11	package	54629060101	derived:openfda.package_ndc
rxcui		1245468	openfda.rxcui
spl id		16a5df9c-f9e1-49dc-99cb-b21dfd97e1bf	id
spl set id		0c66642c-82cb-42cd-82bb-5f95852cc5d1	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. • When abdominal pain, nausea, or vomiting are present. • For longer than one week unless directed by a doctor. Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of two weeks. Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use. If pregnant or breast-feeding, ask a healthcare 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.