DOCUSATE SODIUM, EXTRA STRENGTH 250 MG

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, EXTRA STRENGTH 250 MG
Generic name: DOCUSATE SODIUM
Manufacturer: Advanced Rx LLC
Product type: HUMAN OTC DRUG
SPL set ID: e8be12c5-c591-eadd-e053-2a95a90a431b
SPL ID: 220d2464-6ee6-10d6-e063-6394a90a4f39
Version: 4
Effective date: 2024-09-13
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:58:36

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, EXTRA STRENGTH 250 MG	openfda.brand_name
generic name		DOCUSATE SODIUM	openfda.generic_name
manufacturer name		Advanced Rx LLC	openfda.manufacturer_name
ndc	package	80513-100-01	openfda.package_ndc
ndc	product	80513-100	openfda.product_ndc
ndc11	package	80513010001	derived:openfda.package_ndc
rxcui		1245468	openfda.rxcui
spl id		220d2464-6ee6-10d6-e063-6394a90a4f39	id
spl set id		e8be12c5-c591-eadd-e053-2a95a90a431b	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 directed by a doctor. Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits 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 laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.