FDA.reportPublic FDA data

Docusate Sodium

Product NDC
0904-7609
11-digit product format
009047609
Labeler code
0904
Product ID
0904-7609_8f5fe2d1-2047-45f5-8e9f-a5440b78132b
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-25
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/1

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
1115005Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e8321cf-7eda-d70c-e063-6394a90a35a5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7609-61Docusate Sodium1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED13
0904-7609-61Docusate Sodium100 in 1 CARTONCAPSULE, LIQUID FILLED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7609-61EA - Each0904-76092b039e75-f18f-4348-8026-08491b45d8bc12026-05-22

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 13 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Epsom SaltMAGNESIUM SULFATESam's West, Inc6edb7688-0a64-4a7e-a0c0-9f75c96682fe2026-02-03WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)cb2698b1-6c58-417f-ae86-74fbe38146262026-02-03WarningsExact identifier
application number: M007
Castor OilCASTOR OILCVS Pharmacy, Inc.f20de8f2-3637-4485-8b80-0a12fd5e651c2026-02-02Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATECVS Pharmacy, Inc.1dca8f4a-f544-4ae5-bb0a-8b671d4a488a2026-02-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATECVS Pharmacy, Inc.15a9996d-7391-41f8-ab15-27ee2a6a60e42026-02-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATERite Aid Corporatione562bf42-b9e1-4ea8-b880-7bec4dd620b42026-01-30Warnings, Adverse reactionsExact identifier
application number: M007
SENNA-SDOCUSATE SODIUM AND SENNOSIDESStrategic Sourcing Services, LLC905bd658-a0af-4f20-be3d-00c54868a26c2026-01-29WarningsExact identifier
application number: M007
Senna LaxativeSENNOSIDESStrategic Sourcing Services LLC9248a907-a8bd-47d5-98a2-48534d6023d42026-01-29WarningsExact identifier
application number: M007
Leader Castor OilCASTOR OILCardinal Health, 110 dba Leader49e3a40a-b717-43f6-abed-473d7ed03c2e2026-01-29Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILCARDINAL HEALTH 110, LLC. DBA LEADER803f444f-d136-4f06-9842-24a71a3d7d6b2026-01-29Warnings, Adverse reactionsExact identifier
application number: M007
Equate Ready-to-Use Enema LaxativeSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMWalMart04c7440e-5b25-4b63-9604-321298d510212026-01-29WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMMeijer Distribution Inc.81edf0d8-b6f3-4b3a-85db-0108160756b12026-01-28WarningsExact identifier
application number: M007
Quality Choice LaxativeSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMChain Drug Marketing Association1cac3b6b-155b-47bb-bb79-17c55d3457362026-01-28WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED1ad73079-ebb3-dae7-e063-6294a90a05582026-01-28WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100MGDOCUSATE SODIUM 100MGFarmacias De Similares TX LLC44269b79-a5ad-f443-e063-6294a90a84732026-01-28WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED19830f9a-27b1-910d-e063-6294a90adace2026-01-27WarningsExact identifier
application number: M007
SennosidesSENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED94936bd4-8bbf-6211-e053-2995a90a21382026-01-27Exact identifier
application number: M007
SennosidesSENNOSIDESSoftgel Healthcare Pvt Ltd16582306-7321-6c7c-e063-6394a90a509e2026-01-27WarningsExact identifier
application number: M007
Vegetable LaxativeSENNOSIDESWal-Mart Stores Inc97695092-1ded-4723-a015-fdadd7c28c812026-01-27WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILCVS Pharmacy, Incc3de1c1b-5042-aec3-e053-2a95a90ad1342026-01-27WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN3e8321cf-7eda-d70c-e063-6394a90a35a53
1115005docusate sodium 100 MG Oral CapsuleSCD3e8321cf-7eda-d70c-e063-6394a90a35a53
1115005DOSS Sodium 100 MG Oral CapsuleSY3e8321cf-7eda-d70c-e063-6394a90a35a53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7609-6100904760961100 BLISTER PACK in 1 CARTON (0904-7609-61) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK100 blister pack2025-11-25NoNoCurrent