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 38 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)eb7f3d65-8741-407d-b3f3-1d9dda19684d2024-03-05WarningsExact identifier
application number: M007
FleetSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.f50ba829-16c3-40a7-9822-8d6d00353b332024-02-29WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBJWC (Berkley & Jensen / BJ's)4ce62421-97e0-4920-9a6d-9fa1f0f93fe42024-02-23WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMBryant Ranch Prepack851a5dda-e72b-4067-a98f-54d3222f646e2024-02-23WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBJWC (Berkley & Jensen / BJ's)2ca80e23-f38a-4f77-b536-131cc9f0cf5b2024-02-23WarningsExact identifier
application number: M007
Colon DetoxDOCUSATE SODIUM AND SENNOSIDESOPMX LLC0a4d3265-080c-d2ed-e063-6394a90adbee2024-02-21WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESBest Choice (Valu Merchandisers Company)4501d718-15a7-4e27-bdb1-8aa2d3ff06d02024-02-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBest Choice (Valu Merchandisers Company)72bd251b-4e82-41ef-8362-39f95faf99162024-02-15WarningsExact identifier
application number: M007
Magnesium CitrateLEADER MAGNESIUM CITRATE ORAL SOLUTION - LEMONCARDINAL HEALTH, INC. 06399736010bdd5e6-3db2-8f9e-e063-6394a90a9b3f2024-02-06WarningsExact identifier
application number: M007
Magnesium CitrateLEADER MAGNESIUM CITRATE ORAL SOLUTION - GRAPECARDINAL HEALTH, INC. 06399736010beb3ec-a189-221d-e063-6394a90aabb52024-02-06WarningsExact identifier
application number: M007
Magnesium CitrateLEADER MAGNESIUM CITRATE ORAL SOLUTION - CHERRYCARDINAL HEALTH, INC. 06399736010bebb63-19b3-2e14-e063-6394a90a8d4e2024-02-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMProficient Rx LPf9ac0344-5864-4ac1-81bc-16878a5946c52024-02-01WarningsExact identifier
application number: M007
Purifi Hand SanitizerBENZALKONIUM CHLORIDEPurifi LLC9267069d-4cf5-4e48-a446-7dbebea16bf52024-01-31WarningsExact identifier
application number: M007
WOMENS LAXATIVE ENTERIC COATEDBISACODYLCARDINAL HEALTHab34bc89-6738-d284-e053-2a95a90a5dc92024-01-11WarningsExact identifier
application number: M007
MAXIMUM STRENGTH LAXATIVESENNOSIDESCARDINAL HEALTHb7b13bfa-8a94-6f62-e053-2995a90abbf42024-01-10WarningsExact identifier
application number: M007
FIBER LAXATIVECALCIUM POLYCARBOPHILMagno-Humphries, Inc.e4a921c5-1cf7-12ca-e053-2a95a90a6e042024-01-03WarningsExact identifier
application number: M007
Freskaro Castor OilCASTOR OILPharma Nobis, LLCfbd6bdd5-a7a1-3f28-e053-6294a90aab872023-12-28WarningsExact identifier
application number: M007
Humco Castor OilCASTOR OILPharma Nobis, LLCe42f9d37-1b07-177a-e053-2a95a90a9b062023-12-26WarningsExact identifier
application number: M007
Magnesium CitrateFRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMONPharma Nobis, LLCf0477328-eca1-9043-e053-2995a90aaa3d2023-12-22WarningsExact identifier
application number: M007
Magnesium CitrateFRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRYPharma Nobis, LLCf0489f6f-9e60-7d69-e053-2a95a90a9dfb2023-12-22WarningsExact 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