FDA.reportPublic FDA data

Stool Softener Docusate Sodium

Product NDC
54257-902
11-digit product format
542570902
Labeler code
54257
Product ID
54257-902_08bf67ab-e837-2223-e063-6294a90a0878
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Magno-Humphries, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-04-04
Substance
DOCUSATE SODIUM
Active strength
100 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 · 8 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 packagepackage54257-902-06fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54257-902-0686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54257-902-06bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage54257-902-068dfbde2a14a4…c9ff85d89658…

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 Docusate Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 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
1115005Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a0e6ab9b-fd31-45fd-93d5-b51d705c180aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54257-902-062023-10-29C16284748780-1ba0f9c33-2cdc-a910-e053-dadaa90a0b85Stool Softener Docusate Sodium
54257-902-062021-01-29C16284748780-1ba0f9c33-2cdc-a910-e053-dadaa90a0b85Stool Softener Docusate Sodium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54257-902-02Stool Softener Docusate Sodium100 in 1 BOTTLECAPSULE, GELATIN COATED1006
54257-902-06Stool Softener Docusate Sodium1000 in 1 BOTTLECAPSULE, GELATIN COATED10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54257-902-06EA - Each54257-9021b79f6cd-2f3a-4d3f-bbd4-66d8f726563212018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54257-902STOOL SOFTENER DOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, GELATIN COATED [MAGNO-HUMPHRIES, INC.]6Current NDC, Legacy NDC, 1 package rows20231030_9d22d642-8aed-d17e-e053-2995a90ae182.zip
54257-902STOOL SOFTENER DOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, GELATIN COATED [MAGNO-HUMPHRIES, INC.]5Current NDC, Legacy NDC, 1 package rows20231030_a0e6ab9b-fd31-45fd-93d5-b51d705c180a.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 23 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK OF MAGNESIAMAGNESIUM HYDROXIDEH E Bab995d9a-1e40-2b38-e053-2a95a90a87e42025-08-21WarningsExact identifier
application number: M007
SenokotSTANDARDIZED SENNA CONCENTRATEAtlantis Consumer Healthcare, Inc.d5bf67e5-82c6-edbf-e9ec-e027fdd47c842025-08-20WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMBJWC (Berkley & Jensen / BJ's)330758d2-fc1a-50ce-e063-6294a90a7db12025-08-19WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES AND DOCUSATE SODIUMAmerican Health Packaging4b84d5d7-43cf-47bb-af59-088550c3a0bc2025-08-12WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMGood Sense (Geiss, Destin & Dunn, Inc.)8066a52d-e683-47c1-905c-290d2d427acf2025-08-12WarningsExact identifier
application number: M007
ProlaxaDOCUSATE SODIUM 250MGAdvanced Rx of Tennessee, LLC3ba0c0d9-9e6f-a2e6-e063-6394a90a202d2025-08-05WarningsExact identifier
application number: M007
Dulcolax Stool SoftenerDOCUSATE SODIUMChattem, Inc.86cb7102-3585-4757-9c37-5bf9776bbe632025-08-01WarningsExact identifier
application number: M007
LEADER Mineral OilMINERAL OILCardinal Health, 110 dba Leader7d4f8fa3-8203-5523-e053-2991aa0aba1a2025-07-28WarningsExact identifier
application number: M007
Rapidol Sal InglesaMAGNESIUM SULFATE HEPTAHYDRATEPharmadel LLC1d4ef5f0-54c5-4838-e063-6394a90a44a82025-07-28WarningsExact identifier
application number: M007
Enemeez KidsDOCUSATE SODIUMQuest Products LLCf1602ba4-ad02-2936-e053-2995a90a27f22025-07-15WarningsExact identifier
application number: M007
SennosidesSENNOSIDESBryant Ranch Prepackd4ab04e4-b78a-4afc-aa16-d9dc8fb6cc102025-07-14WarningsExact identifier
application number: M007
Epsom SaltEPSOM SALTStrategic Sourcing Services LLC1515fadd-a7a5-4502-afe2-cfcd50d5bfc82025-07-11WarningsExact identifier
application number: M007
Quality Choice Fiber CapletsCALCIUM POLYCARBOPHILQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)29dbc831-23c1-487d-902a-9404d9ebe8052025-07-09WarningsExact identifier
application number: M007
Rexall Ready to use 4pk LAXATIVESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMDolgencorp, LLC78509915-0ef1-4238-99a5-78a49a68f98f2025-07-07WarningsExact identifier
application number: M007
Sal Inglesa EPSOM SALTMAGNESIUM SULFATE HEPTAHYDRATEMenper Distributors, Inc247aa3a3-d38f-4799-b44d-dfe18324fd0c2025-07-01WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMChain Drug Consortium, LLC550000ba-0d6d-4666-8461-f591c14478b12025-06-27WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEChain Drug Consortium, LLCc9807e6e-9dcc-41a2-8956-b61623ac21762025-06-27WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMChain Drug Consortium, LLC09449649-fd57-4446-8264-6c3bdd6621d02025-06-27WarningsExact identifier
application number: M007
SennaSENNOSIDESBryant Ranch Prepackf2b14378-2b60-4533-b232-8c8647fbce782025-06-26WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTARGET CORPORATION28fce2e2-2101-df88-e063-6394a90aa3de2025-06-25WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN9d22d642-8aed-d17e-e053-2995a90ae1826
1115005docusate sodium 100 MG Oral CapsuleSCD9d22d642-8aed-d17e-e053-2995a90ae1826
1115005DOSS Sodium 100 MG Oral CapsuleSY9d22d642-8aed-d17e-e053-2995a90ae1826
1115005docusate sodium 100 MG Oral CapsulePSNa0e6ab9b-fd31-45fd-93d5-b51d705c180a5
1115005docusate sodium 100 MG Oral CapsuleSCDa0e6ab9b-fd31-45fd-93d5-b51d705c180a5
1115005DOSS Sodium 100 MG Oral CapsuleSYa0e6ab9b-fd31-45fd-93d5-b51d705c180a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54257-902-0254257090202100 CAPSULE, GELATIN COATED in 1 BOTTLE (54257-902-02) 2020-01-240000-00-00NoNoCurrent
54257-902-06542570902061000 CAPSULE, GELATIN COATED in 1 BOTTLE (54257-902-06) 2017-04-04NoNoCurrent