FDA.reportPublic FDA data

Docusate Sodium Liquid

Product NDC
0536-1304
11-digit product format
005361304
Labeler code
0536
Product ID
0536-1304_472e65a6-72c1-d403-e063-6294a90a46a4
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
LIQUID
Route
ORAL
Labeler
RUGBY LABORATORIES
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-01
Substance
DOCUSATE SODIUM
Active strength
50 mg/5mL
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 Liquid
Listing expiration
2026-12-31

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
1248119Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e21d19d8-6c2d-4474-a663-dfe7e91ac320Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1304-85Docusate Sodium Liquid473 mL in 1 BOTTLELIQUID4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1304DOCUSATE SODIUM LIQUID (DOCUSATE SODIUM) LIQUID [RUGBY LABORATORIES]5Current NDC, Legacy NDC, 1 package rows20241222_e21d19d8-6c2d-4474-a663-dfe7e91ac320.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 35 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Pharmacy Fiber-Caps Fiber Laxative Stimulant FreeCALCIUM POLYCARBOPHILAmerisourcebergen Drug Corporation4911fb44-e070-46c1-8f90-b78ceb10e51e2024-06-28WarningsExact identifier
application number: M007
FleetDOCUSATE SODIUMC.B. Fleet Company, Inc.56a7b6c5-d674-4eed-91c2-77f7d18fff322024-06-27WarningsExact identifier
application number: M007
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMWALMART INC. (see also Equate)2cf6c9bf-c318-445d-9306-5675b1d424b02024-06-26WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWALMART INC. (see also Equate)d9db24b5-e3b5-47f9-b86b-bc8d70896a112024-06-26WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE CALCIUMWalgreens2791223a-7ac0-47e5-9a6a-4d9a02cfeb632024-06-25WarningsExact identifier
application number: M007
FleetBISACODYLC.B. Fleet Company, Inc.4e0d973f-e6dc-48d9-8df3-1d47c87840f12024-06-21WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESTOP CARE (Topco Associates LLC)3b184800-649b-45d0-9586-8055d6d7fe082024-06-20WarningsExact identifier
application number: M007
Senna LaxativeSENNA LAXATIVEGood Sense9393032e-4343-4ac5-8e91-36013e5ca0892024-06-18WarningsExact identifier
application number: M007
Stool SoftenerSTOOL SOFTENERGood Sense64266195-1b07-42c2-98a7-d76c12f747762024-06-18WarningsExact identifier
application number: M007
Stool Softener Plus StimulantDOCUSATE SODIUM AND SENNOSIDESUnited Natural Foods, Inc. dba UNFI6c8c7c46-3ded-4e89-8e16-30eeb72aa08b2024-06-14WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESUnited Natural Foods, Inc. dba UNFI50ca1ce2-885f-4b71-a5fb-90c2cf508ce62024-06-14WarningsExact identifier
application number: M007
basic care stool softenerDOCUSATE SODIUMAmazon.com Services LLC356a889f-ec23-4eb2-a25c-bbe6094751552024-06-14WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFI88cc2575-27a1-4514-bc41-bd1eac2838142024-06-13WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESUnited Natural Foods, Inc. dba UNFI2b5e1f03-0182-4d1c-8ba0-b1008b1335ad2024-06-12WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation1b7edd67-7b14-4fdd-9821-637f4b3c3a2c2024-06-06WarningsExact identifier
application number: M007
SennaSENNOSIDESPatrin Pharma, Inc.a9f1ef8d-8700-481f-a709-972bb9d271532024-05-30WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWALGREEN COMPANY5f9cd233-6c46-5b52-e053-2991aa0ab7292024-05-23WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFIb1d903a5-1d5f-44d4-9939-a4b86e5a620d2024-05-23WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESUnited Natural Foods, Inc. dba UNFI30b9bbf3-0a64-41de-bfb4-5c8c257cc3e82024-05-23WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEMEIJER, INC.11fe5bd0-585a-ad8a-e063-6294a90a3ae82024-05-22WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248119docusate sodium 50 MG in 5 mL Oral SuspensionPSNe21d19d8-6c2d-4474-a663-dfe7e91ac3206
1248119docusate sodium 10 MG/ML Oral SuspensionSCDe21d19d8-6c2d-4474-a663-dfe7e91ac3206
1248119docusate sodium 100 MG per 10 ML Oral SuspensionSYe21d19d8-6c2d-4474-a663-dfe7e91ac3206
1248119docusate sodium 150 MG per 15 ML Oral SuspensionSYe21d19d8-6c2d-4474-a663-dfe7e91ac3206
1248119docusate sodium 50 MG per 5 ML Oral SuspensionSYe21d19d8-6c2d-4474-a663-dfe7e91ac3206
1248119DOSS Sodium 10 MG/ML Oral SuspensionSYe21d19d8-6c2d-4474-a663-dfe7e91ac3206
1248119docusate sodium 50 MG in 5 mL Oral SuspensionPSNb23ad877-644d-4fde-bb2e-a6b8a22966da4
1248119docusate sodium 10 MG/ML Oral SuspensionSCDb23ad877-644d-4fde-bb2e-a6b8a22966da4
1248119docusate sodium 100 MG per 10 ML Oral SuspensionSYb23ad877-644d-4fde-bb2e-a6b8a22966da4
1248119docusate sodium 150 MG per 15 ML Oral SuspensionSYb23ad877-644d-4fde-bb2e-a6b8a22966da4
1248119docusate sodium 50 MG per 5 ML Oral SuspensionSYb23ad877-644d-4fde-bb2e-a6b8a22966da4
1248119DOSS Sodium 10 MG/ML Oral SuspensionSYb23ad877-644d-4fde-bb2e-a6b8a22966da4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1304-8500536130485473 mL in 1 BOTTLE (0536-1304-85) 473 ml2020-10-010000-00-00NoNoCurrent