DOCUSATE SODIUM 100mg Two-Tone

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 Two-Tone
Generic name: DOCUSATE SODIUM
Manufacturer: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Product type: HUMAN OTC DRUG
SPL set ID: 7cf1df18-d658-4bff-8a62-365fc5656942
SPL ID: 27c7b0fb-b899-cd95-e063-6394a90a0855
Version: 5
Effective date: 2024-11-25
Source export date: 2026-10-27
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/2c7d3f7bcea1543046130e07dcbaf7eea5fb0ce23f7faa6458d1c6d80c3fa0c3/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:42:15

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 Two-Tone	openfda.brand_name
generic name		DOCUSATE SODIUM	openfda.generic_name
manufacturer name		Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	openfda.manufacturer_name
ndc	package	53345-023-02	openfda.package_ndc
ndc	product	53345-023	openfda.product_ndc
ndc11	package	53345002302	derived:openfda.package_ndc
rxcui		1115005	openfda.rxcui
spl id		27c7b0fb-b899-cd95-e063-6394a90a0855	id
spl set id		7cf1df18-d658-4bff-8a62-365fc5656942	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 presently taking mineral oil, unless told to do so by a doctor Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel movements 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. 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.