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: PD-Rx Pharmaceuticals, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 6a7e4193-22d2-491e-9842-5c43f571fc65
SPL ID: 2d687989-bace-67e9-e063-6394a90a0221
Version: 6
Effective date: 2025-02-05
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:09:08

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	openfda.brand_name
generic name		DOCUSATE SODIUM	openfda.generic_name
manufacturer name		PD-Rx Pharmaceuticals, Inc.	openfda.manufacturer_name
ndc	package	72789-166-60	openfda.package_ndc
ndc	product	72789-166	openfda.product_ndc
ndc11	package	72789016660	derived:openfda.package_ndc
rxcui		1245468	openfda.rxcui
spl id		2d687989-bace-67e9-e063-6394a90a0221	id
spl set id		6a7e4193-22d2-491e-9842-5c43f571fc65	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 (800) 222-1222.

Reported adverse events (FAERS/openFDA)#

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