Docusate Sodium

Product NDC
55154-2346
11-digit product format
551542346
Labeler code
55154
Product ID
55154-2346_8370cf26-77e8-4699-85cb-4a60dc1b6af3
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
LIQUID
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-26
Substance
DOCUSATE SODIUM
Active strength
50 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Docusate Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/5mL

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
1245686Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ee14dfe2-405f-493a-a774-ce1b01d05dd4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-2346-5Docusate Sodium5 in 1 BAGLIQUID54
55154-2346-5Docusate Sodium10 mL in 1 CUP, UNIT-DOSELIQUID104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2346DOCUSATE SODIUM LIQUID [CARDINAL HEALTH 107, LLC]2Current NDC, 2 package rows20240723_ee14dfe2-405f-493a-a774-ce1b01d05dd4.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 17 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DDM Castor OilCASTOR OILDiscount Drug Mart5d1583fa-968a-5987-e053-2991aa0a0d602025-12-19WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcb0765cb-f48e-4daa-97b8-2897a2d955872025-12-19WarningsExact identifier
application number: M007
Humco Castor OilCASTOR OILHumco holding Group, Inc.f2676cf2-f6fb-46b8-b723-5497f16559022025-12-18WarningsExact identifier
application number: M007
Humco Castor Oil (Regular)CASTOR OILHumco Holding Group, Inc.ccf25c1f-d8a2-49b9-8e09-88e6616c9ade2025-12-18WarningsExact identifier
application number: M007
Meijer Magnesium Hydroxide Laxative Soft ChewMAGNESIUM HYDROXIDEMeijer23f826c3-1ad5-b3c8-e063-6394a90a655e2025-12-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMStrategic Sourcing Services LLCba51cca1-b70b-476e-80e6-20cd52292e652025-12-17WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMCVS Pharmacya694b4f3-6112-4a1d-a06e-9e5b20fd3d7b2025-12-17WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCARDINAL HEALTH 110, LLC. DBA LEADER 70000da5ccd75-8a2f-4f90-ae8a-97d81b8579d22025-12-17WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMorepen Laboratories Limited3643eabf-e339-f02c-e063-6394a90aa6a82025-12-16WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEMeijer Distribution Incf425a7aa-2503-2fe8-e053-2995a90ab3522025-12-16WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEMeijer Distribution Inc.f42591f9-c842-018f-e053-2995a90a480f2025-12-16WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEMAJOR Pharmaceuticals Inc.673311f7-0b83-410c-a480-8e57d01902962025-12-11WarningsExact identifier
application number: M007
GeriCare Docusate Sodium LiquidDOCUSATE SODIUMGERI-CARE PHARMACEUTICALS, CORPd599ff49-c9a4-401a-a50b-63d89749bbed2025-12-11WarningsExact identifier
application number: M007
GeriCare Senna SyrupSENNOSIDESGeri-Care Pharmaceutical Corp.05a54614-a6ad-4861-87b8-9e2ee49bad202025-12-11WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMMajor Pharmaceuticals3e8321cf-7eda-d70c-e063-6394a90a35a52025-12-10WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMHEB2f103a88-4cab-d4b9-e063-6394a90ac7fc2025-12-09WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMHEB2efb4c5a-2c5e-acf6-e063-6394a90a934e2025-12-08WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMHEB2f10041a-8c88-09a5-e063-6294a90a07cc2025-12-08WarningsExact identifier
application number: M007
QUALITY CHOICE Fiber TherapyMETHYLCELLULOSECHAIN DRUG MARKETING ASSOCIATION77ac079c-d957-4706-8241-570d7fcfe3aa2025-12-04WarningsExact identifier
application number: M007
Phillips Stool Softener Bulk DocusateDOCUSATE SODIUMBayer HealthCare LLC.b0462555-5554-4a17-a1fe-4206a4fd350d2025-12-04WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245686docusate sodium 50 MG in 5 mL Oral SolutionPSNee14dfe2-405f-493a-a774-ce1b01d05dd44
1245686docusate sodium 10 MG/ML Oral SolutionSCDee14dfe2-405f-493a-a774-ce1b01d05dd44
1245686docusate sodium 10 MG per 1 ML Oral SolutionSYee14dfe2-405f-493a-a774-ce1b01d05dd44
1245686docusate sodium 100 MG per 10 ML Oral SolutionSYee14dfe2-405f-493a-a774-ce1b01d05dd44
1245686docusate sodium 150 MG per 15 ML Oral SolutionSYee14dfe2-405f-493a-a774-ce1b01d05dd44
1245686DOSS Sodium 10 MG/ML Oral SolutionSYee14dfe2-405f-493a-a774-ce1b01d05dd44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55154-2346-5551542346055 CUP, UNIT-DOSE in 1 BAG (55154-2346-5) / 10 mL in 1 CUP, UNIT-DOSE2023-12-26NoNoCurrent