Stool Softener

Product NDC: 69168-420
11-digit product format: 691680420
Labeler code: 69168
Product ID: 69168-420_6eb62390-6dc1-4038-a518-5a8b94cc51dc
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate Sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: Allegiant Health
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-04-10
Substance: DOCUSATE SODIUM
Active strength: 100 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Stool Softener
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOCUSATE SODIUM	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F05Q2T2JA0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1115005	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
30c9ff75-cee4-4632-86fd-acfdf5ee85af	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69168-420-01	Stool Softener	100 in 1 BOTTLE	CAPSULE	100	8
69168-420-30	Stool Softener	30 in 1 BOTTLE	CAPSULE	30	8
69168-420-81	Stool Softener	400 in 1 BOTTLE	CAPSULE	400	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-420	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE [ALLEGIANT HEALTH]	8	Current NDC, Legacy NDC, 3 package rows	20231116_30c9ff75-cee4-4632-86fd-acfdf5ee85af.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 42 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topcare Stool Softener	DOCUSATE SODIUM	TopCo Associates, LLC	6f4fddda-4129-4087-b0e4-ababc5558484	2021-02-19	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Allegiant Health	30c9ff75-cee4-4632-86fd-acfdf5ee85af	2020-10-27	Warnings	Exact identifier application number: M007 ndc (product): 69168-420
Stool Softener	MARC GLASSMAN	Marc Glassman, Inc.	909cd222-d836-416f-aa7d-deb4a0c5a560	2020-09-08	Warnings	Exact identifier application number: M007
Senna Lax	SENNOSIDES 8.6MG	Allegiant Health	94a9c24a-07c3-4535-b810-b7abc9fc5ad5	2019-12-11	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Marc Glassman, Inc.	ec34fc1e-d122-4fa4-859e-e89e3e12edd5	2019-09-18	Warnings	Exact identifier application number: M007
Womens Laxative	BISACODYL	Marc Glassman, Inc.	aeb3c49b-cbf5-4a47-b19c-e77fbb987a49	2019-09-17	Warnings	Exact identifier application number: M007
Bisacodyl 5mg	BISACODYL 5MG	Allegiant Health	46a377f5-822b-496f-a73b-66d8f902680a	2019-03-26	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Allegiant Health	51f1c6c0-770c-4426-820b-bc1f42e143fd	2019-02-07	Warnings	Exact identifier application number: M007
Senna-Lax	SENNOSIDES	Marc Glassman, Inc.	7dd97c54-2ba1-4629-87b9-1ba0913fe531	2016-12-27	Warnings	Exact identifier application number: M007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F05Q2T2JA0	DOCUSATE SODIUM	577-11-7	DOCUSATE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1115005	docusate sodium 100 MG Oral Capsule	PSN	30c9ff75-cee4-4632-86fd-acfdf5ee85af	8
1115005	docusate sodium 100 MG Oral Capsule	SCD	30c9ff75-cee4-4632-86fd-acfdf5ee85af	8
1115005	DOSS Sodium 100 MG Oral Capsule	SY	30c9ff75-cee4-4632-86fd-acfdf5ee85af	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-420-01	69168042001	100 CAPSULE in 1 BOTTLE (69168-420-01)	100 capsule	2015-04-10	0000-00-00	No	No	Current
69168-420-30	69168042030	30 CAPSULE in 1 BOTTLE (69168-420-30)	30 capsule	2021-11-18	0000-00-00	No	No	Current
69168-420-81	69168042081	400 CAPSULE in 1 BOTTLE (69168-420-81)	400 capsule	2021-04-30	0000-00-00	No	No	Current