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

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 · 872 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MiraFAST KIDS soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.58636827-239d-cc63-e063-6294a90a61802026-08-06WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMP & L Development, LLC4e97dd60-96e3-4b51-b614-c62480af19192026-08-06WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLC098d2377-0019-45fe-b995-700b1b1241c42026-08-05WarningsExact identifier
application number: M007
Docusate Sodium softgels 50mg (Dye Free)DOCUSATE SODIUMCVS Pharmacy273ea95f-3c9c-98e8-e063-6294a90a21352026-08-05WarningsExact identifier
application number: M007
Mineral OilMINERAL OILOld East Main Co.4bae831d-caba-40c9-bdb5-2611eac35dd52026-08-05Warnings, Adverse reactionsExact identifier
application number: M007
MiraFAST soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.2cee67dd-b71f-32b8-e063-6394a90ae8642026-08-05WarningsExact identifier
application number: M007
MiraSOFT Stool SoftenerDOCUSATE SODIUMBayer HealthCare LLC.5851f15f-8add-559f-e063-6394a90a7b7d2026-08-05WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcbb0edf4-1fa7-42f5-a6f7-027e3961b50a2026-08-05WarningsExact identifier
application number: M007
Metamucil Therapy for regularityPSYLLIUM HUSKAtlantic Biologicals Corp.57b112ea-f6b1-baa6-e063-6394a90a3b292026-08-04WarningsExact identifier
application number: M007
SennosidesSENNOSIDESLEADER/ Cardinal Health 110, Inc.e3c7ece8-82f3-cd0c-e053-2995a90ad8002026-08-04WarningsExact identifier
application number: M007
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.7793fced-e8ee-44e2-b212-dd2a59a5f4622026-08-04WarningsExact identifier
application number: M007
Dual Action Senna Stool SoftenerDOCUSATE SODIUM 50 MG, SENNOSIDES 8.6 MGShield Pharmaceuticals Corpa04435df-aace-497f-a3a8-d8e8489db6612026-08-03WarningsExact identifier
application number: M007
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMCardinal Health 107, LLCb5e4b14d-bf11-4309-bf6d-65ee9d877a242026-07-28WarningsExact identifier
application number: M007
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
application number: M007
Curewell Senna SyrupSENNOSIDESRMT HEALTH LLC57345324-5140-5cde-e063-6294a90ab97c2026-07-22WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATE ORAL SOLUTIONWALGREEN COMPANY4ffe54ae-3126-ba58-e063-6294a90a88772026-07-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackdeca083b-5c72-40fa-9021-b74028426a5a2026-07-20WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCfc5e82b6-e25c-4686-9781-2205819685f52026-07-20WarningsExact identifier
application number: M007
Best Choice Fiber Therapy Orange FlavorPSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)0b25f6c0-441b-41ef-ab19-2a29705a56c62026-07-17WarningsExact identifier
application number: M007
Best Choice Fiber Therapy original coarsePSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)d7eb71af-17e3-465e-b464-f77b3be7266d2026-07-17WarningsExact 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