FDA.reportPublic FDA data

Docusate Sodium Liquid

Product NDC
73564-813
11-digit product format
735640813
Labeler code
73564
Product ID
73564-813_58b4cbbb-02dd-b19e-e063-6394a90a9e70
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium.50mg/5mL
Dosage form
SOLUTION
Route
ORAL
Labeler
Aldama Pharmaceuticals, Inc
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-01
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 Liquid
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
492b6d37-47cf-3a28-e063-6294a90a2a18Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73564-813-16Docusate Sodium Liquid1 in 1 BOXSOLUTION11
73564-813-16Docusate Sodium Liquid473 mL in 1 BOTTLESOLUTION4731

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 23 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK OF MAGNESIAMAGNESIUM HYDROXIDEH E Bab995d9a-1e40-2b38-e053-2a95a90a87e42025-08-21WarningsExact identifier
application number: M007
SenokotSTANDARDIZED SENNA CONCENTRATEAtlantis Consumer Healthcare, Inc.d5bf67e5-82c6-edbf-e9ec-e027fdd47c842025-08-20WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMBJWC (Berkley & Jensen / BJ's)330758d2-fc1a-50ce-e063-6294a90a7db12025-08-19WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES AND DOCUSATE SODIUMAmerican Health Packaging4b84d5d7-43cf-47bb-af59-088550c3a0bc2025-08-12WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMGood Sense (Geiss, Destin & Dunn, Inc.)8066a52d-e683-47c1-905c-290d2d427acf2025-08-12WarningsExact identifier
application number: M007
ProlaxaDOCUSATE SODIUM 250MGAdvanced Rx of Tennessee, LLC3ba0c0d9-9e6f-a2e6-e063-6394a90a202d2025-08-05WarningsExact identifier
application number: M007
Dulcolax Stool SoftenerDOCUSATE SODIUMChattem, Inc.86cb7102-3585-4757-9c37-5bf9776bbe632025-08-01WarningsExact identifier
application number: M007
LEADER Mineral OilMINERAL OILCardinal Health, 110 dba Leader7d4f8fa3-8203-5523-e053-2991aa0aba1a2025-07-28WarningsExact identifier
application number: M007
Rapidol Sal InglesaMAGNESIUM SULFATE HEPTAHYDRATEPharmadel LLC1d4ef5f0-54c5-4838-e063-6394a90a44a82025-07-28WarningsExact identifier
application number: M007
Enemeez KidsDOCUSATE SODIUMQuest Products LLCf1602ba4-ad02-2936-e053-2995a90a27f22025-07-15WarningsExact identifier
application number: M007
SennosidesSENNOSIDESBryant Ranch Prepackd4ab04e4-b78a-4afc-aa16-d9dc8fb6cc102025-07-14WarningsExact identifier
application number: M007
Epsom SaltEPSOM SALTStrategic Sourcing Services LLC1515fadd-a7a5-4502-afe2-cfcd50d5bfc82025-07-11WarningsExact identifier
application number: M007
Quality Choice Fiber CapletsCALCIUM POLYCARBOPHILQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)29dbc831-23c1-487d-902a-9404d9ebe8052025-07-09WarningsExact identifier
application number: M007
Rexall Ready to use 4pk LAXATIVESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMDolgencorp, LLC78509915-0ef1-4238-99a5-78a49a68f98f2025-07-07WarningsExact identifier
application number: M007
Sal Inglesa EPSOM SALTMAGNESIUM SULFATE HEPTAHYDRATEMenper Distributors, Inc247aa3a3-d38f-4799-b44d-dfe18324fd0c2025-07-01WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMChain Drug Consortium, LLC550000ba-0d6d-4666-8461-f591c14478b12025-06-27WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEChain Drug Consortium, LLCc9807e6e-9dcc-41a2-8956-b61623ac21762025-06-27WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMChain Drug Consortium, LLC09449649-fd57-4446-8264-6c3bdd6621d02025-06-27WarningsExact identifier
application number: M007
SennaSENNOSIDESBryant Ranch Prepackf2b14378-2b60-4533-b232-8c8647fbce782025-06-26WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTARGET CORPORATION28fce2e2-2101-df88-e063-6394a90aa3de2025-06-25WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245686docusate sodium 50 MG in 5 mL Oral SolutionPSN492b6d37-47cf-3a28-e063-6294a90a2a182
1245686docusate sodium 10 MG/ML Oral SolutionSCD492b6d37-47cf-3a28-e063-6294a90a2a182
1245686docusate sodium 10 MG per 1 ML Oral SolutionSY492b6d37-47cf-3a28-e063-6294a90a2a182
1245686docusate sodium 100 MG per 10 ML Oral SolutionSY492b6d37-47cf-3a28-e063-6294a90a2a182
1245686docusate sodium 150 MG per 15 ML Oral SolutionSY492b6d37-47cf-3a28-e063-6294a90a2a182
1245686DOSS Sodium 10 MG/ML Oral SolutionSY492b6d37-47cf-3a28-e063-6294a90a2a182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73564-813-16735640813161 BOTTLE in 1 BOX (73564-813-16) / 473 mL in 1 BOTTLE1 bottle2026-06-01NoNoCurrent