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 29 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chocolated LaxativeSENNOSIDES STIMULANT LAXATIVEWalgreensc8ea170b-57b5-4643-ba88-4cf2ae1bf6a02024-12-23WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMeijer, Inc.b09a234e-962d-49fc-a72e-898547b2f0992024-12-23WarningsExact identifier
application number: M007
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.4e15f6ca-a40c-485f-be3f-07c2ed7cb4982024-12-23WarningsExact identifier
application number: M007
Chocolate Laxative Regular strength, Sennosides Stimulant Laxative, equateSENNOSIDESWal-Mart Stores Inc10dc8b4d-8136-44a5-a2ce-30295866cd3b2024-12-23WarningsExact identifier
application number: M007
Chocolated Laxative Regular Strength Sennosides Stimulant Laxative, Best ChoiceSENNOSIDESValu Merchandisers Company4b7cab4b-a610-4fb9-ac31-011975f1b29c2024-12-23WarningsExact identifier
application number: M007
Chocolated Laxative Regular Strength Sennosides Stimulant Laxative, DG healthSENNOSIDESDolgencorp Inc.88dc2f9b-18ca-4e21-8faa-5339f82a2a752024-12-23WarningsExact identifier
application number: M007
Chocolated Laxative Regular Strength Sennosides Stimulant Laxative TopCare healthSENNOSIDESTopco Associatesf051b302-f70e-4ab6-bb69-f69b45f2642e2024-12-23WarningsExact identifier
application number: M007
Chocolated LaxativeSENNOSIDES STIMULANT LAXATIVEC.D.M.A., Inc.e80be2b6-a0ca-4838-b956-a1debb065d572024-12-23WarningsExact identifier
application number: M007
ConlaxBISACODYLBliss GVS Pharma Limited7d25990b-6f7c-1eac-e053-2a91aa0a70222024-12-21WarningsExact identifier
application number: M007
GeriCare Docusate Sodium LiquidDOCUSATE SODIUMGERI-CARE PHARMACEUTICALS, CORPe50558e1-f0c8-4b03-9109-6a273b61730d2024-12-20WarningsExact identifier
application number: M007
SENNA SyrupSENNOSIDES A AND BSDA Laboratories, Inc.cfc6ab2f-5376-46fc-ac58-7dedd70100062024-12-20WarningsExact identifier
application number: M007
Fiber TherapyCALCIUM POLYCARBOPHILWal-Mart Stores, Inc.3432a4a6-aeb1-4a72-8451-5903266931fa2024-12-20WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILUNITED NATURAL FOODS, INC. DBA UNFIf7236bbc-8ded-4e11-8cce-b0a2255e14502024-12-20WarningsExact identifier
application number: M007
Fiber CapsCALCIUM POLYCARBOPHILGuardian Drug Company31e6b0c7-1d4a-4660-ae87-9d18e0001dcd2024-12-19WarningsExact identifier
application number: M007
Epsom SaltsMAGNESIUM SULFATENEW PRIDE CORPf6626023-4857-518b-e053-2a95a90a98212024-12-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEWALGREEN COMPANY5fae9b56-2555-b583-e053-2991aa0a8d592024-12-19WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWALGREEN COMPANY5faf2ed0-dd71-17c9-e053-2a91aa0ab75a2024-12-19WarningsExact identifier
application number: M007
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGRUGBY LABORATORIESf5afd8eb-d35d-44ab-897d-1d41c98ca1382024-12-19WarningsExact identifier
application number: M007
Goodsense FiberMETHYLCELLULOSEGoodSense96ed1ba1-7f91-4912-a549-a4be2c3e03622024-12-19WarningsExact identifier
application number: M007
Senexon-SDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGRUGBY LABORATORIES2e758ff1-3083-4245-8f58-1c47b042bfdd2024-12-19WarningsExact 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