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 12 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Well at Walgreens Castor OilCASTOR OILWalgreen Co.e41f8553-3812-4d0b-95f8-20b2612792992026-02-12Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEWalgreen Co.b5a02809-6e01-4e01-b1c3-2b10c5091a4e2026-02-12Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILWalgreen Co.822fd02a-92b0-4010-8bfb-737dba331d542026-02-12Warnings, Adverse reactionsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDERugby Laboratories5fd89979-903e-4b31-872d-3b8974af3a6b2026-02-09WarningsExact identifier
application number: M007
Epsom SaltEPSOM SALTEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)1845ea0c-0cb6-482b-abe6-fa17785c5b902026-02-09WarningsExact identifier
application number: M007
Colace Fast-Acting Saline LaxativeMAGNESIUM HYDROXIDEAtlantis Consumer Healthcare, Inc.572adfaf-6e26-42e5-b65d-6d356a0bdfa92026-02-06WarningsExact identifier
application number: M007
Castor OilCASTOR OILRetail Business Services, LLC4e9c41fa-f240-4986-bb13-541bfeb0e50b2026-02-06WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATERetail Business Services, LLCf3661952-ef4f-4f29-93e6-ec09b84643652026-02-06Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATERetail Business Services, LLC2f6e9f87-4bff-482b-a54f-f51ca99aac8c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATERetail Business Services, LLC1a8b540c-b66e-4dca-b7af-23705ae247b62026-02-06Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILRetail Business Services, LLCb0abcdf9-c226-424f-8970-c2135708c6c82026-02-06Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEPublix Super Markets, Inc.e985e071-5541-456e-ae4d-dba85287fe752026-02-05Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEDiscount Drug Marta82a4aa9-c8af-4383-9d92-ba6c596f00952026-02-04WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEDiscount Drug Martb05a94d2-5cc6-4989-9fb8-096e54fa78522026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEGrocery Outlet, Inc.3dff4b00-e71a-1dc0-e063-6394a90a715f2026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEHARRIS TEETER73065a04-b7cd-437d-9624-f845f5ec93bf2026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Harris TeeterMINERALHarris Teeter401e3a7e-54be-47cc-88c3-a343f5cbbd102026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEHy-Vee, Inc.45374a86-80a4-481c-e063-6294a90a381a2026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEHy-Vee, Inc.44592ee0-13dd-57b1-e063-6394a90ab4022026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATECVS Pharmacy, Inc.a78d991a-ba21-4bc4-b8f9-f8dafbddc28f2026-02-03Warnings, 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