Stool Softener Laxative

Product NDC: 63868-946
11-digit product format: 638680946
Labeler code: 63868
Product ID: 63868-946_866fb276-b4fd-4634-b66e-38a6b29bb980
Type: HUMAN OTC DRUG
Nonproprietary name: docusate sodium and sennosides
Dosage form: TABLET
Route: ORAL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-03-31
Substance: DOCUSATE SODIUM; SENNOSIDES
Active strength: 50; 8.6 mg/1; 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	50 mg/1
SENNOSIDES	8.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F05Q2T2JA0	Internal UNII lookup
3FYP5M0IJX	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998740	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
72f8e8d7-ee38-4bd3-8711-f11fded0cede	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-946-01	Stool Softener Laxative	100 in 1 BOTTLE, PLASTIC	TABLET	100		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-946	STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	5	Current NDC, Legacy NDC, 1 package rows	20240502_72f8e8d7-ee38-4bd3-8711-f11fded0cede.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 41 of 41 · 817 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOK	DOCUSATE SODIUM	MAJOR PHARMACEUTICALS	7a92070d-98cc-662f-e053-2991aa0aa1b2	2023-10-23	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	KROGER COMPANY	a1afaa71-7e8c-5a49-e053-2a95a90a4db0	2023-10-23	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Geri-Care Pharmaceutical Corp	644d81ec-d38f-4172-a087-727b94e2fefe	2023-10-19	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Asclemed USA, Inc.	30fc8c07-c26b-4bcc-a727-6e193f5727fd	2023-10-16	Warnings	Exact identifier application number: M007
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
3FYP5M0IJX	SENNOSIDES		SENNOSIDES

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
998740	sennosides 8.6 MG / docusate sodium 50 MG Oral Tablet	PSN	72f8e8d7-ee38-4bd3-8711-f11fded0cede	5
998740	docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SCD	72f8e8d7-ee38-4bd3-8711-f11fded0cede	5
998740	DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SY	72f8e8d7-ee38-4bd3-8711-f11fded0cede	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-946-01	63868094601	100 TABLET in 1 BOTTLE, PLASTIC (63868-946-01)	100 tablet	2021-03-31	0000-00-00	No	No	Current