FDA.reportPublic FDA data

Docusate Sodium

Product NDC
60687-878
11-digit product format
606870878
Labeler code
60687
Product ID
60687-878_328399bd-5afd-f961-e063-6294a90a7c0a
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
LIQUID
Route
ORAL
Labeler
American Health Packaging
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-20
Substance
DOCUSATE SODIUM
Active strength
100 mg/10mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/10mL

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
e5028f6d-d33d-47a9-8453-00af5cdf59a6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-878-42Docusate Sodium10 mL in 1 CUP, UNIT-DOSELIQUID101
60687-878-48Docusate Sodium10 in 1 TRAYLIQUID101
60687-878-56Docusate Sodium10 in 1 CASELIQUID101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-878-42ML - Milliliter60687-8785ce48099-6623-41c4-857a-bf7c1fb1458312025-05-14
60687-878-56ML - Milliliter60687-878b1bc5e56-c291-4fa8-93ec-f726a85a4cba12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-878DOCUSATE SODIUM LIQUID [AMERICAN HEALTH PACKAGING]1Current NDC, 3 package rows20250425_e5028f6d-d33d-47a9-8453-00af5cdf59a6.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 2 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Epsom SaltMAGNESIUM SULFATECardinal Health, 110 dba Leaderd27dc1cc-5e17-40d3-84fe-c1792552cfd52026-08-25Warnings, Adverse reactionsExact identifier
application number: M007
HyVee Senna SDOCUSATE SODIUM, SENNOSIDESHyVee Inc4982b9c6-ed0e-24da-e063-6394a90a147f2026-08-24WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ccec364a-3135-4a5d-b4b0-86b832387b4e2026-08-24WarningsExact identifier
application number: M007
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.a1591da0-a1a9-9583-3cf5-788b8fee38142026-08-24Exact identifier
application number: M007
MiraFAST soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.2cee67dd-b71f-32b8-e063-6394a90ae8642026-08-21WarningsExact identifier
application number: M007
HyVee Senna SDOCUSATE SODIUM, SENNOSIDESHyVee Inc49837b2c-492f-2fed-e063-6294a90aaa242026-08-21WarningsExact identifier
application number: M007
Senokot-SSTANDARDIZED SENNA CONCENTRATE AND DOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.c24cdc5e-62e0-41a6-8afb-512202a569f42026-08-21WarningsExact identifier
application number: M007
Foster and Thrive Senna-S Sennosides and Docusate Sodium Laxative and Stool SoftenerDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGStrategic Sourcing Services LLC5966ff80-7be2-788a-e063-6294a90ab4f32026-08-19WarningsExact identifier
application number: M007
Epsom SaltEPSOM SALTAmerisourceBergen (Good Neighbor Pharmacy) 46122d22fb02f-09c4-476a-b6d6-d3a2fd30049d2026-08-18WarningsExact identifier
application number: M007
FiberconCALCIUM POLYCARBOPHILMedtech Products Inc.59534afd-fe38-818a-e063-6394a90a21ea2026-08-18WarningsExact identifier
application number: M007
CVS Stool Softener Fruit PunchDOCUSATE SODIUMCVS PHARMACY, INC0e6900d6-7dc9-47d6-a006-1695feb8d5a52026-08-17WarningsExact identifier
application number: M007
CVS Senna LaxativeSENNOSIDESCVS PHARMACY5a5565b2-827f-4fcc-a835-d827f62da8f92026-08-17WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)306fd12b-ed60-40dc-a5be-2dc394bd29d22026-08-17WarningsExact identifier
application number: M007
CVS Health Childrens Saline LaxativeMAGNESIUM HYDROXIDECVS PHARMACY,INC.e57e5529-2190-4c66-8397-bc2848739e592026-08-14WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESMorepen Bio Inc562d1b9a-09d8-92fc-e063-6394a90a19932026-08-14WarningsExact identifier
application number: M007
CVS HealthNATURAL FIBER SUPPLEMENTCVS Pharmacy,Inc.04dbe9aa-ed18-4d76-a840-d010445a86432026-08-14WarningsExact identifier
application number: M007
CVS Fiber TherapyMETHYLCELLULOSECVS PHARMACYe066f5bd-5f34-4e04-beec-3c7d6db493812026-08-13WarningsExact identifier
application number: M007
Mineral oilMINERAL OILEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)92f2147d-b52d-4282-b217-28f6095dca0e2026-08-12WarningsExact identifier
application number: M007
CAREONE Orange FlavoredPSYLLIUM HUSKFOODHOLD USA4b1cccd2-e941-4d51-9924-4ca35e3a44292026-08-11WarningsExact identifier
application number: M007
CAREONEPSYLLIUM HUSKFOODHOLD USA3ec3ead0-382e-4765-bbe8-b21e7c7b42a62026-08-11WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245686docusate sodium 50 MG in 5 mL Oral SolutionPSNe5028f6d-d33d-47a9-8453-00af5cdf59a61
1245686docusate sodium 10 MG/ML Oral SolutionSCDe5028f6d-d33d-47a9-8453-00af5cdf59a61
1245686docusate sodium 10 MG per 1 ML Oral SolutionSYe5028f6d-d33d-47a9-8453-00af5cdf59a61
1245686docusate sodium 100 MG per 10 ML Oral SolutionSYe5028f6d-d33d-47a9-8453-00af5cdf59a61
1245686docusate sodium 150 MG per 15 ML Oral SolutionSYe5028f6d-d33d-47a9-8453-00af5cdf59a61
1245686DOSS Sodium 10 MG/ML Oral SolutionSYe5028f6d-d33d-47a9-8453-00af5cdf59a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-878-426068708784210 mL in 1 CUP, UNIT-DOSE10 mlHistorical
60687-878-486068708784810 in 1 TRAYHistorical
60687-878-566068708785610 TRAY in 1 CASE (60687-878-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-878-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-878-42) 10 tray2025-04-20NoNoCurrent