Stool Softener Laxative

Product NDC: 0363-4100
11-digit product format: 003634100
Labeler code: 0363
Product ID: 0363-4100_dba5a864-8145-44a3-8c89-42870b53ad19
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate Sodium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Walgreens
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-12-31
Substance: DOCUSATE SODIUM
Active strength: 100 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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 Laxative
Listing expiration: 2027-12-31

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
92df761b-da68-4ce9-b02a-a5a74fd6620e	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-4100-20	Stool Softener Laxative	200 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	200	8
0363-4100-40	Stool Softener Laxative	400 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	400	8
0363-4100-60	Stool Softener Laxative	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	8
0363-4100-60	Stool Softener Laxative	60 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	60	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-4100-40	EA - Each	0363-4100	80e6ceb4-bbdf-4dd4-bef6-991983e510ac	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-4100	STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [WALGREENS]	5	Current NDC, Legacy NDC, 4 package rows	20231020_92df761b-da68-4ce9-b02a-a5a74fd6620e.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 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Extra Strength	DOCUSATE SODIUM	MEIJER, INC.	e43bd2ed-17c7-4530-af72-81a7ad70069c	2023-10-12	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	Care One (Retail Business Services, LLC.)	9adaec97-43e3-48f2-96c8-c508b693676c	2023-10-05	Warnings	Exact identifier application number: M007
Senna Lax	SENNOSIDES 8.6MG	TopCo Associates, LLC	83aeb90a-ab00-4e26-aa44-5259dce59018	2021-04-28	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Allegiant Health	9fbe783e-ddd9-445a-852a-00f4ad754880	2021-04-20	Warnings	Exact identifier application number: M007
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
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	92df761b-da68-4ce9-b02a-a5a74fd6620e	8
1115005	docusate sodium 100 MG Oral Capsule	SCD	92df761b-da68-4ce9-b02a-a5a74fd6620e	8
1115005	DOSS Sodium 100 MG Oral Capsule	SY	92df761b-da68-4ce9-b02a-a5a74fd6620e	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-4100-20	00363410020	200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-4100-20)	2020-12-31	0000-00-00	No	No	Current
0363-4100-40	00363410040	400 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-4100-40)	2020-12-31	0000-00-00	No	No	Current
0363-4100-60	00363410060	1 BOTTLE, PLASTIC in 1 BOX (0363-4100-60) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC	2020-12-31	0000-00-00	No	No	Current