Stool Softener

Product NDC: 57896-426
Requested package NDC: 57896-426-01
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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	57896-426	57896-426-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	57896-426	57896-426-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	57896-426	57896-426-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`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 32 of 42 · 826 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOCUSATE SODIUM 100mg Two-Tone	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	7cf1df18-d658-4bff-8a62-365fc5656942	2024-11-25	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM 100mg	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	c5bdfbfc-d24a-4088-9b60-ecea8120ff43	2024-11-25	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	b10fdf50-289e-41f3-9b83-a4e4dd892f88	2024-11-21	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM 100mg Two-Tone	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	85c64624-428d-46fa-8071-f42b8feec049	2024-11-21	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd	33251cb7-b7b1-4f6c-9e10-4fa64cbf03a0	2024-11-21	Warnings	Exact identifier application number: M007
STOOL SOFTENER	DOCUSATE SODIUM	Walgreen Co.	d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab5	2024-11-21	Warnings	Exact identifier application number: M007
4718 Enema, Mineral Oil	4718 ENEMA, MINERAL OIL	Dynarex	9e51c852-9477-5cf5-e053-2a95a90a97db	2024-11-20	Warnings	Exact identifier application number: M007
Relief	SODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	Leosons Overseas Corp	5b301d5b-1e2c-47ed-a05f-d6be0fdfc940	2024-11-19	Warnings	Exact identifier application number: M007
REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Leosons Overseas Corp	90e7c2b4-35e1-4a27-afea-9257c480e190	2024-11-19	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM 100MG	PuraCap Pharmaceutical LLC	272c86f1-f229-2ebf-e063-6394a90a3471	2024-11-18	Warnings	Exact identifier application number: M007
Milk of Magnesia Concentrate	MAGNESIUM HYDROXIDE	PAI Holdings, LLC dba PAI Pharma	2a99a1a8-a830-429f-9cfd-3f29c3d3547c	2024-11-12	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	A-S Medication Solutions	122486e9-74dd-4181-97d1-0b07688280f4	2024-11-06	Warnings	Exact identifier application number: M007
Stratuscare Adult Glycerin	GLYCERIN	Stratus Pharmaceuticals	3e1935da-5c1f-4942-98dd-320fade82321	2024-11-04	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM	DOCUSATE SODIUM	NuCare Pharmaceuticals,Inc.	fdf3c8e1-d554-4cdb-e053-6394a90a542e	2024-11-01	Warnings	Exact identifier application number: M007
Stratuscare Glycerin Laxative Pediatric	GLYCERIN	Stratus Pharmaceuticals	6ae6d3c4-bb3b-4436-b76d-8654bf871e66	2024-11-01	Warnings	Exact identifier application number: M007
Rite Aid Fiber Therapy	METHYLCELLULOSE	RITE AID CORPORATION	e50cea80-c020-4b85-b61f-d053f11f479b	2024-10-30	Warnings	Exact identifier application number: M007
Rite Aid Fiber Caplets	CALCIUM POLYCARBOPHIL	RITE AID CORPORATION	06e46cb0-2928-479e-984d-2305fff995e0	2024-10-30	Warnings	Exact identifier application number: M007
Premier Value Orange Flavor	PSYLLIUM HUSK	PHARMACY VALUE ALLIANCE, LLC	2d580965-2bef-46ee-8532-fbe34330a4b4	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value Fiber Therapy	METHYLCELLULOSE	PHARMACY VALUE ALLIANCE, LLC	b875d5f8-02f3-4474-9fda-83091bc7de04	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value Fiber Therapy Original Coarse	PSYLLIUM HUSK	PHARMACY VALUE ALLIANCE, LLC	8c85a13d-ae99-4599-9a28-c3965caa6376	2024-10-28	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