FDA.reportPublic FDA data

Docusate Sodium Liquid

Product NDC
54859-813
11-digit product format
548590813
Labeler code
54859
Product ID
54859-813_4745fe35-8aba-b427-e063-6394a90ab073
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
LIQUID
Route
ORAL
Labeler
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-01
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
2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-813-16Docusate Sodium Liquid473 mL in 1 BOTTLELIQUID4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-813-16ML - Milliliter54859-81325502fa9-6f5b-4d15-898f-034a45e4599b12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54859-813DOCUSATE SODIUM LIQUID (DOCUSATE SODIUM) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]8Current NDC, Legacy NDC, 1 package rows20241228_2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c.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 11 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral OilMINERAL OILUnited Natural Foods, Inc. dba UNFIcb7bc571-295f-47c2-ae93-18cba194752c2026-02-17Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILStrategic Sourcing Services LLCe4965086-dcc0-4b34-bb30-81facf7139f32026-02-17Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEValu Merchandisers Companycd3e5836-b2f0-41f3-8623-3105c46424912026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATEValu Merchandisers Companya693f6b0-0679-4609-9ca0-dddfa4158c022026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEValu Merchandisers Companyfb358bc3-e479-42e7-8aea-a6a3676f24302026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEValu Merchandisers Companyff539c1c-9ed3-49be-9b30-1858f12e1e902026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILUnited Natural Foods, Inc. dba UNFIbd19bea3-5ac9-4f8d-b1a0-478fd9c8a01f2026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
Walgreens SmoothLAX Soft ChewsMAGNESIUM HYDROXIDEWalgreens424e27ce-0b11-9cd2-e063-6294a90a3c212026-02-16WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATEUnited Natural Foods, Inc. dba UNFIda013c15-3531-4dc5-b122-bfc99bc494ae2026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEUnited Natural Foods, Inc. dba UNFIdb1bc651-1a35-4f92-a917-c6a19f4215942026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMThe Kroger Co.e1a68bd9-d31a-46a6-8c08-7ad8197b6e0b2026-02-13WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETopco Associates LLCb2ec06b3-647d-49ab-a392-6db63d96d1e32026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILTopco Associates LLC5643f2e0-93e2-4c2e-90a0-fd152150d18a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATETopco Associates LLCd3cc7cb6-098e-413c-b1ad-7ebf5fa352692026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATETopco Associates LLCbc89c4bc-5207-479d-9a3b-e570b412a7ba2026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETopco Associates LLC72f69aa0-381a-4e5c-975d-3a73fdc1b3772026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILTopco Associates LLCe9b1fd61-c229-4529-82c2-d6ac5b0760822026-02-13WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEPinnacle RX LLC4abbb0e4-e005-bc4e-e063-6394a90a126a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
365 Whole Foods Market Epsom SaltMAGNESIUM SULFATEWhole Foods Market, Inc.4147cdd0-57f6-3857-e063-6394a90afecb2026-02-12Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEYour Military Exchanges27cff497-123c-424a-9c43-57740c00168b2026-02-12Warnings, 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 SuspensionPSN2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c9
1248119docusate sodium 10 MG/ML Oral SuspensionSCD2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c9
1248119docusate sodium 100 MG per 10 ML Oral SuspensionSY2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c9
1248119docusate sodium 150 MG per 15 ML Oral SuspensionSY2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c9
1248119docusate sodium 50 MG per 5 ML Oral SuspensionSY2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c9
1248119DOSS Sodium 10 MG/ML Oral SuspensionSY2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c9
1248119docusate sodium 50 MG in 5 mL Oral SuspensionPSNefe4bf81-fb99-4755-aa23-4f8df5973be83
1248119docusate sodium 10 MG/ML Oral SuspensionSCDefe4bf81-fb99-4755-aa23-4f8df5973be83
1248119docusate sodium 100 MG per 10 ML Oral SuspensionSYefe4bf81-fb99-4755-aa23-4f8df5973be83
1248119docusate sodium 150 MG per 15 ML Oral SuspensionSYefe4bf81-fb99-4755-aa23-4f8df5973be83
1248119docusate sodium 50 MG per 5 ML Oral SuspensionSYefe4bf81-fb99-4755-aa23-4f8df5973be83
1248119DOSS Sodium 10 MG/ML Oral SuspensionSYefe4bf81-fb99-4755-aa23-4f8df5973be83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54859-813-1654859081316473 mL in 1 BOTTLE (54859-813-16) 473 ml2021-12-010000-00-00NoNoCurrent