COLACE EXTRA STRENGTH STOOL SOFTNER

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: COLACE EXTRA STRENGTH STOOL SOFTNER
Generic name: DOCUSATE SODIUM
Manufacturer: Atlantis Consumer Healthcare Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 34e06b05-64a5-4b3e-af38-cdcd7c1d521b
SPL ID: cb4d4f5a-9ae0-4cab-9806-017c6088f77f
Version: 3
Effective date: 2025-05-01
Source export date: 2026-11-06
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 08:09:30

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M007	openfda.application_number
brand name		COLACE EXTRA STRENGTH STOOL SOFTNER	openfda.brand_name
generic name		DOCUSATE SODIUM	openfda.generic_name
manufacturer name		Atlantis Consumer Healthcare Inc.	openfda.manufacturer_name
ndc	package	67618-201-12	openfda.package_ndc
ndc	package	67618-201-60	openfda.package_ndc
ndc	product	67618-201	openfda.product_ndc
ndc11	package	67618020112	derived:openfda.package_ndc
ndc11	package	67618020160	derived:openfda.package_ndc
rxcui		1245468	openfda.rxcui
rxcui		2692740	openfda.rxcui
spl id		cb4d4f5a-9ae0-4cab-9806-017c6088f77f	id
spl set id		34e06b05-64a5-4b3e-af38-cdcd7c1d521b	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 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 can be signs of a serious condition you need to use a stool softner laxative for more than 1 week If pregnant or breast-feeding , ask a health care professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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