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 15 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Gentle LaxativeBISACODYLCVS Pharmacy0cca1516-fc8d-4471-bd37-a6230fd225e22026-01-14WarningsExact identifier
application number: M007
Rite-Aid Gentle LaxativeBISACODYLRITE AID PHARMACY0fb853db-8d97-64d6-e063-6294a90abeb52026-01-14WarningsExact identifier
application number: M007
Rite-Aid Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fb8f488-3386-29b9-e063-6294a90a014c2026-01-14WarningsExact identifier
application number: M007
Rite-Aid Childrens Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fbe4dfd-1d5d-fc31-e063-6394a90ab3172026-01-14WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMTOP CARE (Topco Associates LLC)92659389-c36f-499b-b284-5b520e50e9a62026-01-14WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDESAVPAKaf75d33f-b081-4b9d-bc12-d2829fa1f0cf2026-01-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)597d2e9c-1adb-4c7d-ada3-de5c2db69c742026-01-09WarningsExact identifier
application number: M007
Foster and Thrive Ready to Use Mineral oil LaxativeMINERAL OILStrategic Sourcing Services LLCea6da66c-6825-4cd7-8791-45b537bf203a2026-01-08WarningsExact identifier
application number: M007
Sunmark Saline Single LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMStrategic Sourcing Services LLC06720229-7d58-499e-b7de-cb4bda5ae4162026-01-08WarningsExact identifier
application number: M007
HealthMart Mineral Oil Single LaxativeMINERAL OILStrategic Sourcing Services LLC1238ec69-1ea3-4773-9f13-71f0ae0a35532026-01-08WarningsExact identifier
application number: M007
HealthMart Saline Single LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMStrategic Sourcing Services LLC689228de-1f3e-4205-853d-6004d62488572026-01-08WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacyc445864f-fc88-4885-9f40-d189b9dc42902026-01-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFIc46a1f7c-12e3-4be1-b9e4-d3edac0f43862026-01-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTOP CARE (Topco Associates LLC)44fe6ce0-5fed-418f-8a6a-d6132e2883282026-01-07WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMStrategic Sourcing Services LLC24e29f00-f1cf-4e92-bd67-3f6f820af7832026-01-07WarningsExact identifier
application number: M007
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMP & L Development, LLC33000a06-e030-433a-8f9c-7ae5c08037fa2026-01-06WarningsExact identifier
application number: M007
Stool Softener Regular StrengthDOCUSATE SODIUMSam's West, Inc1eca5910-b0bf-4e07-8211-36dba52b3de72026-01-06WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEMajor Pharmaceuticalsc3d14605-fdec-49fc-b0ee-d4c3ae5f42b52026-01-05WarningsExact identifier
application number: M007
GeriCare Sorbitol SolutionSORBITOLGERI-CARE PHARMACEUTICALS, CORPb4dd7a41-380e-d94b-e053-2a95a90ac34a2025-12-31WarningsExact identifier
application number: M007
Docusate Sodium LiquidDOCUSATE SODIUMLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c2025-12-31WarningsExact 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