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
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 · 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
2026-12-31

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 3 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f4671579-aed0-4f93-ab83-248e0d72b5b02026-08-10WarningsExact identifier
application number: M007
Docusate Sodium LiquidDOCUSATE SODIUM.50MG/5MLAldama Pharmaceuticals, Inc492b6d37-47cf-3a28-e063-6294a90a2a182026-08-10WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATESafeway Inc0b757160-f9eb-4413-9b43-97544c49c72f2026-08-10Warnings, Adverse reactionsExact identifier
application number: M007
Bisacodyl LaxativeBISACODYLInvaDerm Corporation58ba9a9f-98d8-c380-e063-6294a90a774c2026-08-10WarningsExact identifier
application number: M007
SennosidesSENNOSIDESCardinal Health 107, LLC4a9e1cbe-ffe4-462f-a86d-078a357dcf492026-08-07WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM, SENNOSIDESShield Pharmaceuticals Corp0be906d8-3db5-4218-bbdf-f1d1260079902026-08-07WarningsExact identifier
application number: M007
MiraFAST KIDS soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.58636827-239d-cc63-e063-6294a90a61802026-08-06WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMP & L Development, LLC4e97dd60-96e3-4b51-b614-c62480af19192026-08-06WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLC098d2377-0019-45fe-b995-700b1b1241c42026-08-05WarningsExact identifier
application number: M007
Docusate Sodium softgels 50mg (Dye Free)DOCUSATE SODIUMCVS Pharmacy273ea95f-3c9c-98e8-e063-6294a90a21352026-08-05WarningsExact identifier
application number: M007
Mineral OilMINERAL OILOld East Main Co.4bae831d-caba-40c9-bdb5-2611eac35dd52026-08-05Warnings, Adverse reactionsExact identifier
application number: M007
Metamucil Therapy for regularityPSYLLIUM HUSKAtlantic Biologicals Corp.57b112ea-f6b1-baa6-e063-6394a90a3b292026-08-05WarningsExact identifier
application number: M007
WinCo Pure 5lbPURE 5LB EPSOM SALTWinCo Foods, LLC58529382-a192-cda2-e063-6394a90adb692026-08-05WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcbb0edf4-1fa7-42f5-a6f7-027e3961b50a2026-08-05WarningsExact identifier
application number: M007
SennosidesSENNOSIDESLEADER/ Cardinal Health 110, Inc.e3c7ece8-82f3-cd0c-e053-2995a90ad8002026-08-04WarningsExact identifier
application number: M007
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
application number: M007
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.7793fced-e8ee-44e2-b212-dd2a59a5f4622026-08-04WarningsExact identifier
application number: M007
Dual Action Senna Stool SoftenerDOCUSATE SODIUM 50 MG, SENNOSIDES 8.6 MGShield Pharmaceuticals Corpa04435df-aace-497f-a3a8-d8e8489db6612026-08-03WarningsExact identifier
application number: M007
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMCardinal Health 107, LLCb5e4b14d-bf11-4309-bf6d-65ee9d877a242026-07-28WarningsExact identifier
application number: M007
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact 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