FDA.reportPublic FDA data

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage57896-426-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57896-426-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57896-426-01bd6a592717d7…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
IngredientStrength
DOCUSATE SODIUM250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1245468Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b595063a-5fee-18c2-e053-2a95a90a5b99Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57896-426-012022-11-30C16284748780-1d6a99b39-6659-a426-e053-dadaa90af4c2gc425 (426)
57896-426-012022-01-28C16284748780-1d6a99b39-6659-a426-e053-dadaa90af4c2gc425 (426)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-426-01Stool Softener100 in 1 BOTTLECAPSULE, LIQUID FILLED1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-426STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [GERI-CARE PHARMACEUTICAL CORP]4Current NDC, Legacy NDC, 1 package rows20231116_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 13 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Epsom SaltMAGNESIUM SULFATESam's West, Inc6edb7688-0a64-4a7e-a0c0-9f75c96682fe2026-02-03WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)cb2698b1-6c58-417f-ae86-74fbe38146262026-02-03WarningsExact identifier
application number: M007
Castor OilCASTOR OILCVS Pharmacy, Inc.f20de8f2-3637-4485-8b80-0a12fd5e651c2026-02-02Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATECVS Pharmacy, Inc.1dca8f4a-f544-4ae5-bb0a-8b671d4a488a2026-02-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATECVS Pharmacy, Inc.15a9996d-7391-41f8-ab15-27ee2a6a60e42026-02-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATERite Aid Corporatione562bf42-b9e1-4ea8-b880-7bec4dd620b42026-01-30Warnings, Adverse reactionsExact identifier
application number: M007
SENNA-SDOCUSATE SODIUM AND SENNOSIDESStrategic Sourcing Services, LLC905bd658-a0af-4f20-be3d-00c54868a26c2026-01-29WarningsExact identifier
application number: M007
Senna LaxativeSENNOSIDESStrategic Sourcing Services LLC9248a907-a8bd-47d5-98a2-48534d6023d42026-01-29WarningsExact identifier
application number: M007
Leader Castor OilCASTOR OILCardinal Health, 110 dba Leader49e3a40a-b717-43f6-abed-473d7ed03c2e2026-01-29Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILCARDINAL HEALTH 110, LLC. DBA LEADER803f444f-d136-4f06-9842-24a71a3d7d6b2026-01-29Warnings, Adverse reactionsExact identifier
application number: M007
Equate Ready-to-Use Enema LaxativeSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMWalMart04c7440e-5b25-4b63-9604-321298d510212026-01-29WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMMeijer Distribution Inc.81edf0d8-b6f3-4b3a-85db-0108160756b12026-01-28WarningsExact identifier
application number: M007
Quality Choice LaxativeSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMChain Drug Marketing Association1cac3b6b-155b-47bb-bb79-17c55d3457362026-01-28WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED1ad73079-ebb3-dae7-e063-6294a90a05582026-01-28WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100MGDOCUSATE SODIUM 100MGFarmacias De Similares TX LLC44269b79-a5ad-f443-e063-6294a90a84732026-01-28WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED19830f9a-27b1-910d-e063-6294a90adace2026-01-27WarningsExact identifier
application number: M007
SennosidesSENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED94936bd4-8bbf-6211-e053-2995a90a21382026-01-27Exact identifier
application number: M007
SennosidesSENNOSIDESSoftgel Healthcare Pvt Ltd16582306-7321-6c7c-e063-6394a90a509e2026-01-27WarningsExact identifier
application number: M007
Vegetable LaxativeSENNOSIDESWal-Mart Stores Inc97695092-1ded-4723-a015-fdadd7c28c812026-01-27WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILCVS Pharmacy, Incc3de1c1b-5042-aec3-e053-2a95a90ad1342026-01-27WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245468docusate sodium 250 MG Oral CapsulePSNb595063a-5fee-18c2-e053-2a95a90a5b994
1245468docusate sodium 250 MG Oral CapsuleSCDb595063a-5fee-18c2-e053-2a95a90a5b994
1245468DOSS Sodium 250 MG Oral CapsuleSYb595063a-5fee-18c2-e053-2a95a90a5b994
1245468docusate sodium 250 MG Oral CapsulePSN1f11cf85-b094-4ca4-8b48-2d3a9093304b3
1245468docusate sodium 250 MG Oral CapsuleSCD1f11cf85-b094-4ca4-8b48-2d3a9093304b3
1245468DOSS Sodium 250 MG Oral CapsuleSY1f11cf85-b094-4ca4-8b48-2d3a9093304b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57896-426-0157896042601100 CAPSULE, LIQUID FILLED in 1 BOTTLE (57896-426-01) 2020-04-010000-00-00NoNoCurrent