Stool Softener

Product NDC: 57896-426
11-digit product format: 578960426
Labeler code: 57896
Product ID: 57896-426_0a34593a-4c33-3ddd-e063-6394a90a58c1
Type: HUMAN OTC DRUG
Nonproprietary name: DOCUSATE SODIUM
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Geri-Care Pharmaceutical Corp
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-04-01
Substance: DOCUSATE SODIUM
Active strength: 250 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
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	57896-426-01	`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	57896-426-01	`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	57896-426-01	`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
Listing expiration: 2026-12-31

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
b595063a-5fee-18c2-e053-2a95a90a5b99	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57896-426-01	2022-11-30	C162847	48780-1	d6a99b39-6659-a426-e053-dadaa90af4c2	gc425 (426)
57896-426-01	2022-01-28	C162847	48780-1	d6a99b39-6659-a426-e053-dadaa90af4c2	gc425 (426)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57896-426-01	Stool Softener	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57896-426	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [GERI-CARE PHARMACEUTICAL CORP]	4	Current NDC, Legacy NDC, 1 package rows	20231116_b595063a-5fee-18c2-e053-2a95a90a5b99.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 28 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Laxative Docusate Sodium with Senna	DOCUSATE SODIUM AND SENNOSIDES	TOPCO ASSOCIATES LLC	cf9075d8-e20e-419a-b996-9b12f49f05f2	2025-01-01	Warnings	Exact identifier application number: M007
Vegetable Laxative and Stool Softner	DOCUSATE SODIUM AND SENNOSIDES	TOPCO ASSOCIATES LLC	e84d693d-0041-4c11-8f6a-b5c332f79af9	2025-01-01	Warnings	Exact identifier application number: M007
Acetaminophen	EXTRA STRENGTH PAIN RELIEF	NuCare Pharmaceuticals,Inc.	a32f346e-71d0-cc11-e053-2a95a90ae88c	2024-12-31	Warnings	Exact identifier application number: M007
Laxacin	DOCUSATE SODIUM AND SENNOSIDES	Advanced Rx Pharmacy of Tennessee, LLC	fe7d4d75-0f8a-1e7d-e053-6394a90afb4d	2024-12-31	Warnings	Exact identifier application number: M007
NATUREPLEX Enema	(SALINE)	Natureplex, LLC	0bd6d0a8-33e5-40be-a6c6-33fea92b11dd	2024-12-31	Warnings	Exact identifier application number: M007
Magnesium Citrate	CVS MAGNESIUM CITRATE ORAL SOLUTION - LEMON	CVS Pharmacy, Inc.	fb7f9b67-ff0e-3af4-e053-6294a90ac539	2024-12-30	Warnings	Exact identifier application number: M007
Magnesium Citrate	CVS MAGNESIUM CITRATE ORAL SOLUTION - GRAPE	CVS Pharmacy, Inc.	fb808dc5-bf80-836c-e053-6294a90a80aa	2024-12-30	Warnings	Exact identifier application number: M007
Magnesium Citrate	CVS MAGNESIUM CITRATE ORAL SOLUTION - CHERRY	CVS Pharmacy, Inc.	fb80ffce-a7b6-7f19-e053-6294a90a5c6b	2024-12-30	Warnings	Exact identifier application number: M007
Foster and Thrive Castor Oil	CASTOR OIL	Strategic Sourcing Services, LLC	004d1dc2-47c1-84d1-e063-6394a90a2471	2024-12-30	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM	DOCUSATE SODIUM	A-S Medication Solutions	946abcdb-96bd-43e6-992a-bb97679c00f0	2024-12-30	Warnings	Exact identifier application number: M007
HEB Maximum strength Laxative pills	SENNOSIDES	H E B	86e5dff5-91e6-47a5-8f3c-b1e86adfc1f4	2024-12-26	Warnings	Exact identifier application number: M007
Equaline Regular Strength Chocolated Stimulant Laxative	SENNOSIDES	United Natural Foods, Inc. dba UNFI	e9200d63-a0d1-4f68-bb5e-7507c46cf800	2024-12-26	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	WALGREEN COMPANY	effad954-b70d-d8e6-e053-2a95a90acaf7	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	WALGREEN COMPANY	effad365-d76e-71af-e053-2995a90aa020	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	WALGREEN COMPANY	effaeff6-c48b-1558-e053-2995a90ab52f	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	STRATEGIC SOURCING SERVICES	f9e1291a-f64d-2431-e053-6394a90a35f1	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	AMERISOURCE BERGEN	f384094e-c4d2-3882-e053-2995a90a7794	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	AMERISOURCE BERGEN	f3847b0f-802d-73d7-e053-2a95a90a5bbe	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	STRATEGIC SOURCING SERVICES	f9e1291a-f650-2431-e053-6394a90a35f1	2024-12-23	Warnings	Exact identifier application number: M007
Leader Regular Strength Chocolate Laxative sennosides	SENNOSIDES	CARDINAL HEALTH	1b7d8486-5b3b-44b7-a7b4-63ee2b836d6e	2024-12-23	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	b595063a-5fee-18c2-e053-2a95a90a5b99	4
1245468	docusate sodium 250 MG Oral Capsule	SCD	b595063a-5fee-18c2-e053-2a95a90a5b99	4
1245468	DOSS Sodium 250 MG Oral Capsule	SY	b595063a-5fee-18c2-e053-2a95a90a5b99	4
1245468	docusate sodium 250 MG Oral Capsule	PSN	1f11cf85-b094-4ca4-8b48-2d3a9093304b	3
1245468	docusate sodium 250 MG Oral Capsule	SCD	1f11cf85-b094-4ca4-8b48-2d3a9093304b	3
1245468	DOSS Sodium 250 MG Oral Capsule	SY	1f11cf85-b094-4ca4-8b48-2d3a9093304b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57896-426-01	57896042601	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (57896-426-01)	2020-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
gc425 (426)	NuCare Pharmaceuticals, Inc.	2026-06-04	HUMAN OTC DRUG LABEL	1
gc425 (426)	Bryant Ranch Prepack	2024-04-04	HUMAN OTC DRUG LABEL	3
gc425 (426)	Geri-Care Pharmaceutical Corp	2023-11-15	HUMAN OTC DRUG LABEL	4