Stool Softener Laxative

Product NDC: 59726-879
11-digit product format: 597260879
Labeler code: 59726
Product ID: 59726-879_5df65d78-8a3f-42dd-b596-1d1baf4b60c3
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate Sodium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: P & L Development, LLC
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-11-29
Substance: DOCUSATE SODIUM
Active strength: 250 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59726-879-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59726-879-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59726-879-10	`bd6a592717d7…`	`303034d00443…`

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
Brand name suffix: Extra Strength
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOCUSATE SODIUM	250 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
1245468	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
c1e9863a-c229-4694-b450-6b0e0ad37503	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59726-879-10	2022-12-14	C162847	48780-1	d6a99b39-6ba0-a426-e053-dadaa90af4c2	Drug Facts
59726-879-10	2022-01-28	C162847	48780-1	d6a99b39-6ba0-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59726-879-10	Stool Softener LaxativeExtra Strength	100 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	100		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59726-879	STOOL SOFTENER LAXATIVE EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [P & L DEVELOPMENT, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20240502_c1e9863a-c229-4694-b450-6b0e0ad37503.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 37 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Laxative Plus Stimulant	DOCUSATE SODIUM AND SENNOSIDES	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	dcab26ff-2c10-4478-90a8-c89d87261bfa	2024-03-19	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	4d1391da-7874-4a51-a468-2843ecf6f92b	2024-03-18	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	adaea845-e029-422d-a947-d8ce8f5787ed	2024-03-18	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	8b033d56-b95b-4905-9f33-cf2fbd61ce35	2024-03-15	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	CVS Pharmacy	6a97a181-1ec2-473d-a588-db2f2f2f662d	2024-03-14	Warnings	Exact identifier application number: M007
Stool Softener Extra Strength	DOCUSATE SODIUM	CVS Pharmacy	dcd27653-4c81-4630-a8b7-5fb5dc3e976a	2024-03-13	Warnings	Exact identifier application number: M007
EX-LAX REGULAR STRENGTH STIMULANT LAXATIVE	SENNOSIDES	Haleon US Holdings LLC	62544c2f-6e30-4cec-ae63-233715ef0699	2024-03-13	Warnings	Exact identifier application number: M007
Laxative Stool Softener	DOCUSATE SODIUM, SENNOSIDES	CVS Pharmacy	b52181e3-fd84-479e-8590-18619f6c0dae	2024-03-13	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	CVS Pharmacy	5eb047d2-8317-4de3-9268-d206ca039e3d	2024-03-13	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	CVS Pharmacy	f77c65b0-3e13-48ce-a2d9-36a9eba1851f	2024-03-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	CVS Pharmacy	849b057a-dc46-423c-a2f4-b01f135a3803	2024-03-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE CALCIUM	CVS Pharmacy	cf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cf	2024-03-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	CVS Pharmacy	8d59fa14-fc7c-4146-ba59-c2a907356dd6	2024-03-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Costco Wholesale	a19c20bd-84ff-4931-8312-2fbf0400e8e0	2024-03-06	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Care One (Retail Business Services, LLC.)	a1ea0993-2d23-44e3-bc72-e4bf497ab723	2024-03-05	Warnings	Exact identifier application number: M007
Senna Laxative	SENNOSIDES	Care One (Retail Business Services, LLC.)	a5994303-c9d0-4c6f-8eb7-5f364aa6ed0f	2024-03-05	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Care One (Retail Business Services, LLC.)	eb7f3d65-8741-407d-b3f3-1d9dda19684d	2024-03-05	Warnings	Exact identifier application number: M007
Fleet	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC	C.B. Fleet Company, Inc.	f50ba829-16c3-40a7-9822-8d6d00353b33	2024-02-29	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	BJWC (Berkley & Jensen / BJ's)	4ce62421-97e0-4920-9a6d-9fa1f0f93fe4	2024-02-23	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Bryant Ranch Prepack	851a5dda-e72b-4067-a98f-54d3222f646e	2024-02-23	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
1245468	docusate sodium 250 MG Oral Capsule	PSN	c1e9863a-c229-4694-b450-6b0e0ad37503	3
1245468	docusate sodium 250 MG Oral Capsule	SCD	c1e9863a-c229-4694-b450-6b0e0ad37503	3
1245468	DOSS Sodium 250 MG Oral Capsule	SY	c1e9863a-c229-4694-b450-6b0e0ad37503	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59726-879-10	59726087910	100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (59726-879-10)	2019-11-29	0000-00-00	No	No	Current