FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
0904-7280
11-digit product format
009047280
Labeler code
0904
Product ID
0904-7280_9106599b-ff0f-4d97-a4e4-ce9ca098e23c
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
2022-11-15
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
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
Stool Softener Laxative
Listing expiration
2027-12-31

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
97561cd4-63d9-44c2-a3a3-ec668a09a4edAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7280-60Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1009
0904-7280-80Stool Softener Laxative1000 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7280-60EA - Each0904-728026a1e584-5c99-4037-9a6b-ca3b57d707f212023-03-13
0904-7280-80EA - Each0904-7280d88438cf-e71a-4f39-b013-ee79652343c412023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7280STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]8Current NDC, Legacy NDC, 2 package rows20240904_97561cd4-63d9-44c2-a3a3-ec668a09a4ed.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 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 CapsulePSNd616685a-11fc-4ae0-80de-7d25c0d71ee9104
1115005docusate sodium 100 MG Oral CapsuleSCDd616685a-11fc-4ae0-80de-7d25c0d71ee9104
1115005DOSS Sodium 100 MG Oral CapsuleSYd616685a-11fc-4ae0-80de-7d25c0d71ee9104
1115005docusate sodium 100 MG Oral CapsulePSN5d300ea7-78eb-4e19-8333-1e42c73c4c5410
1115005docusate sodium 100 MG Oral CapsuleSCD5d300ea7-78eb-4e19-8333-1e42c73c4c5410
1115005DOSS Sodium 100 MG Oral CapsuleSY5d300ea7-78eb-4e19-8333-1e42c73c4c5410
1115005docusate sodium 100 MG Oral CapsulePSN97561cd4-63d9-44c2-a3a3-ec668a09a4ed9
1115005docusate sodium 100 MG Oral CapsuleSCD97561cd4-63d9-44c2-a3a3-ec668a09a4ed9
1115005DOSS Sodium 100 MG Oral CapsuleSY97561cd4-63d9-44c2-a3a3-ec668a09a4ed9
1115005docusate sodium 100 MG Oral CapsulePSN867a7771-6846-427d-b526-b964d74f77004
1115005docusate sodium 100 MG Oral CapsuleSCD867a7771-6846-427d-b526-b964d74f77004
1115005DOSS Sodium 100 MG Oral CapsuleSY867a7771-6846-427d-b526-b964d74f77004
1115005docusate sodium 100 MG Oral CapsulePSN4d678da0-9ada-4d00-9db9-33b45c7761073
1115005docusate sodium 100 MG Oral CapsuleSCD4d678da0-9ada-4d00-9db9-33b45c7761073
1115005DOSS Sodium 100 MG Oral CapsuleSY4d678da0-9ada-4d00-9db9-33b45c7761073
1115005docusate sodium 100 MG Oral CapsulePSNccfa095c-77f0-41ff-84f8-e02d983c7c742
1115005docusate sodium 100 MG Oral CapsulePSNfdf3c8e1-d554-4cdb-e053-6394a90a542e2
1115005docusate sodium 100 MG Oral CapsuleSCDccfa095c-77f0-41ff-84f8-e02d983c7c742
1115005docusate sodium 100 MG Oral CapsuleSCDfdf3c8e1-d554-4cdb-e053-6394a90a542e2
1115005DOSS Sodium 100 MG Oral CapsuleSYfdf3c8e1-d554-4cdb-e053-6394a90a542e2
1115005DOSS Sodium 100 MG Oral CapsuleSYccfa095c-77f0-41ff-84f8-e02d983c7c742
1115005docusate sodium 100 MG Oral CapsulePSN2c65319f-6cf5-aa90-e063-6394a90ad6621
1115005docusate sodium 100 MG Oral CapsuleSCD2c65319f-6cf5-aa90-e063-6394a90ad6621
1115005DOSS Sodium 100 MG Oral CapsuleSY2c65319f-6cf5-aa90-e063-6394a90ad6621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-7280-6000904728060100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0904-7280-60) 2022-11-150000-00-00NoNoCurrent
0904-7280-80009047280801000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0904-7280-80) 2022-11-150000-00-00NoNoCurrent