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 1 of 44 · 865 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENOKOTSTANDARDIZED SENNAA-S Medication Solutions0c6e6bdd-9f49-4550-b60a-8f58b7c0f0902026-09-09WarningsExact identifier
application number: M007
BisacodylBISACODYLKROGER COMPANYa13a8eec-3652-8c57-e053-2995a90aaebf2026-09-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation4180a35b-cc50-46ae-a100-99bb218c10ff2026-09-09WarningsExact identifier
application number: M007
fiber laxativePSYLLIUM HUSKRaritan Pharmaceuticals Inc22e927bd-5734-424e-8870-1aaa18f1265e2026-09-08WarningsExact identifier
application number: M007
DRx Choice Fiber TherapyMETHYLCELLULOSERARITAN PHARMACEUTICALS INC5e5749f7-074e-4bbc-9f33-5090e603fdb42026-09-08WarningsExact identifier
application number: M007
Bisacodyl Stimulant LaxativeBISACODYLRaritan Pharmaceuticals Incb99c1a6d-3034-4822-8540-210179c068572026-09-08WarningsExact identifier
application number: M007
Daily Fiber Sugar FreePSYLLIUM HUSKRaritan Pharmaceuticals Inc9c4c41d8-a2d5-4168-9e97-9f9d47fc5e632026-09-08WarningsExact identifier
application number: M007
DRx Choice Fiber TherapyMETHYLCELLULOSERARITAN PHARMACEUTICALS INC56c7f197-f01a-4611-a761-cda18da6eed02026-09-08WarningsExact identifier
application number: M007
Sennosides 8.6 mgSENNOSIDESMorepen Bio Inc562c9f11-0ba1-011d-e063-6394a90a604a2026-09-05WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETarget Corporation87f98e6c-a3a1-4ca5-bd56-977e38f489142026-09-04Warnings, Adverse reactionsExact identifier
application number: M007
Kroger Stool Softener Fruit PunchDOCUSATE SODIUMKROGER COMPANYb86f8f3d-594e-466c-854a-b8bff9f7a0b82026-09-02WarningsExact identifier
application number: M007
OilMINERAL OILAtlantic Biologicals Corp.5a82197b-281d-76c0-e063-6294a90a57462026-09-02Warnings, Adverse reactionsExact identifier
application number: M007
Kroger Senna Laxative Regular StrengthSENNOSIDESKROGER COMPANYdbb040bb-21f9-43e8-9705-689aeee4d04c2026-09-01WarningsExact identifier
application number: M007
OneLAX SENNASENNAAkron Pharma Inc.27fa8f54-ed84-4afd-8da3-8754da48643b2026-09-01WarningsExact identifier
application number: M007
OneLAX Saline LaxativeMAGNESIUM CITRATEAKRON PHARMA INC44c87bbc-2507-4b87-a74b-02f4acb30cf42026-09-01WarningsExact identifier
application number: M007
OneLAX Saline LaxativeMAGNESIUM CITRATEAKRON PHARMA INCe6de00e6-dd81-4aab-af23-04fab261c6ff2026-09-01WarningsExact identifier
application number: M007
EZ2Go Magnesium Citrate Saline Laxative Lemon FlavorMAGNESIUM CITRATEValley Medical Products LLC5a71e88c-d8cc-a8bb-e063-6294a90af4f72026-09-01WarningsExact identifier
application number: M007
Fiber CapletsCALCIUM POLYCARBOPHILTHE KROGER CO.d6856f59-ccc3-40fc-9bf1-7a5394ed12da2026-09-01WarningsExact identifier
application number: M007
Mineral OilMINERAL OILYour Military Exchanges6025dce6-02e8-418c-a248-0b5c33ff60672026-08-28Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEChain Drug Marketing Association583b64e7-e48d-6ba6-e063-6294a90ad4d72026-08-28Warnings, Adverse reactionsExact 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