FDA.reportPublic FDA data

Docusate Sodium

Product NDC
55154-2346
11-digit product format
551542346
Labeler code
55154
Product ID
55154-2346_8370cf26-77e8-4699-85cb-4a60dc1b6af3
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
LIQUID
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-26
Substance
DOCUSATE SODIUM
Active strength
50 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Listing expiration
2027-12-31

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
1245686Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ee14dfe2-405f-493a-a774-ce1b01d05dd4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-2346-5Docusate Sodium5 in 1 BAGLIQUID54
55154-2346-5Docusate Sodium10 mL in 1 CUP, UNIT-DOSELIQUID104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2346DOCUSATE SODIUM LIQUID [CARDINAL HEALTH 107, LLC]2Current NDC, 2 package rows20240723_ee14dfe2-405f-493a-a774-ce1b01d05dd4.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 39 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magnesium CitrateFRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPEPharma Nobis, LLCf0488c86-6c74-3987-e053-2a95a90a31b42023-12-22WarningsExact identifier
application number: M007
Mineral Oil HeavyMINERAL OILPharma Nobis, LLCe42f6c6d-c4de-02c6-e053-2995a90a3ace2023-12-22WarningsExact identifier
application number: M007
Quality Choice Castor OilCASTOR OILChain Drug Market Asociation18d7124f-7745-45b2-adc4-cb1103add5d62023-12-20WarningsExact identifier
application number: M007
Premiere Value Castor OilCASTOR OILChain Drug Consortium5c8c1564-fcff-894b-e053-2991aa0a9c0b2023-12-20WarningsExact identifier
application number: M007
Magnesium CitrateBE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - CHERRYBionpharma, Inc.f0fa4b72-50a5-5c42-e053-2995a90a159a2023-12-20WarningsExact identifier
application number: M007
Harris Teeter Castor OilCASTOR OILHarris Teeter, LLC5cca6b4b-d88f-1c7d-e053-2991aa0a051f2023-12-20WarningsExact identifier
application number: M007
Magnesium CitrateBE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - LEMONBionpharma, Inc.f0f9c36e-c43b-05d2-e053-2995a90a6d652023-12-20WarningsExact identifier
application number: M007
Magnesium CitrateBE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - GRAPEBionpharma, Inc.f0f9ff19-ae08-0af0-e053-2a95a90ab8422023-12-20WarningsExact identifier
application number: M007
CVS Mineral OilMINERAL OILCVS9d7402e1-524b-1084-e053-2a95a90ae3af2023-12-20WarningsExact identifier
application number: M007
Top Care Castor OilCASTOR OILTOPCO ASSOCIATES LLC8dce1a1f-e765-9c75-e053-2995a90abf9f2023-12-18WarningsExact identifier
application number: M007
Humco Epson SaltMAGNESIUM SULFATEHumco Holding Group, Inc.7a9d1b77-6c39-46f1-86f2-4059dde20f852023-12-15WarningsExact identifier
application number: M007
Humco Mineral Oil HeavyMINERAL OILHumco Holding Group, Inc.9f943fdf-5058-4e18-ba96-6be112bf72ca2023-12-15WarningsExact identifier
application number: M007
Rite Aid Castor OilCASTOR OILRite Aid Corporation.5e0d3664-b01b-ba28-e053-2991aa0a8a4c2023-12-15WarningsExact identifier
application number: M007
GNP Castor OilCASTOR OILAmerisource Bergen5d06bec6-f1e7-4f0c-e053-2991aa0a8ad82023-12-14WarningsExact identifier
application number: M007
SankaijoDOCUSATE SODIUM, SENNOSIDESSato Pharmaceutical Co., Ltd.83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b2023-11-29WarningsExact identifier
application number: M007
SIMPEX Bisacodyl laxativeBISACODYLSimpex Pharma Pvt. Ltd5114ed64-4fec-401b-8a91-8df3e42b10b12023-11-29WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corpb595063a-5fee-18c2-e053-2a95a90a5b992023-11-15WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEPublixcbf7dcef-7623-b333-e053-2a95a90a0f1a2023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEMeijer, Inc.bb8b51e9-ba4a-270d-e053-2a95a90a318b2023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDESTRATEGIC SOURCING SERVICES LLCff0d4b9f-7ce8-dd98-e053-6394a90ab6142023-11-08WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245686docusate sodium 50 MG in 5 mL Oral SolutionPSNee14dfe2-405f-493a-a774-ce1b01d05dd44
1245686docusate sodium 10 MG/ML Oral SolutionSCDee14dfe2-405f-493a-a774-ce1b01d05dd44
1245686docusate sodium 10 MG per 1 ML Oral SolutionSYee14dfe2-405f-493a-a774-ce1b01d05dd44
1245686docusate sodium 100 MG per 10 ML Oral SolutionSYee14dfe2-405f-493a-a774-ce1b01d05dd44
1245686docusate sodium 150 MG per 15 ML Oral SolutionSYee14dfe2-405f-493a-a774-ce1b01d05dd44
1245686DOSS Sodium 10 MG/ML Oral SolutionSYee14dfe2-405f-493a-a774-ce1b01d05dd44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55154-2346-5551542346055 CUP, UNIT-DOSE in 1 BAG (55154-2346-5) / 10 mL in 1 CUP, UNIT-DOSE2023-12-26NoNoCurrent