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: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Product type: HUMAN OTC DRUG
SPL set ID: b10fdf50-289e-41f3-9b83-a4e4dd892f88
SPL ID: 2766d54c-3cf9-0b55-e063-6394a90a886d
Version: 4
Effective date: 2024-11-21
Source export date: 2026-11-06
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/824fe785252d7061429a95ddb6de517ee399ef628d34e8fdcc3591ded286ae33/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:24:10

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		Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	openfda.manufacturer_name
ndc	package	53345-008-02	openfda.package_ndc
ndc	package	53345-008-01	openfda.package_ndc
ndc	product	53345-008	openfda.product_ndc
ndc11	package	53345000801	derived:openfda.package_ndc
ndc11	package	53345000802	derived:openfda.package_ndc
rxcui		1115005	openfda.rxcui
spl id		2766d54c-3cf9-0b55-e063-6394a90a886d	id
spl set id		b10fdf50-289e-41f3-9b83-a4e4dd892f88	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 vomitting a sudden change in bowel habits that lasts more than 2 weeks Ask a doctor or pharmacist before use if you are presently taking mineral oil Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. you need to use a 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.