FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
49035-385
11-digit product format
490350385
Labeler code
49035
Product ID
49035-385_a024baf1-c8f3-4426-8d0c-10c53433d17f
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-01
Marketing end
2026-12-28
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-385-50Stool Softener Laxative50 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-385-50EA - Each49035-38586d852ec-6ba4-498b-9665-ba6d036b4a9812025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-385STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]3Current NDC, Legacy NDC, 1 package rows20240322_6484c373-697f-4a81-a375-8cb97223a42c.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 25 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Docusate Sodium Oral LiquidDOCUSATE SODIUM ORAL LIQUIDKesin Pharma Corporation331277b8-8304-d082-e063-6394a90a4dd32025-04-18WarningsExact identifier
application number: M007
Mineral OilMINERAL OILAmerisourceBergen (Good Neighbor Pharmacy) 46122581f81a0-7488-4c90-b33e-06c6301a4fd22025-04-17WarningsExact identifier
application number: M007
Vegetable LaxativeSENNOSIDESWalmart Inc.26dc60e7-5a05-64c3-e063-6394a90a55ce2025-04-14WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEStrategic Sourcing Services LLC99aa30ed-9659-4f60-a31d-6aaf09909b512025-04-14WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILGeri-Care Pharmaceutical Corp616b4399-7626-5e59-e053-2a91aa0a0f752025-04-07WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILCITRAGEN PHARMACEUTICALS, INC.b23dd90f-ba5a-80fc-e053-2995a90a22862025-04-03WarningsExact identifier
application number: M007
Phillips Milk Of Magnesia Wild CherryPHILLIPS MILK OF MAGNESIA WILD CHERRYBayer HealthCare LLC.0a6d824a-3d9a-07f9-e054-00144ff8d46c2025-04-01WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATECVS PHARMACY30ce5cbd-cc7a-0b2d-e063-6394a90a85202025-03-20WarningsExact identifier
application number: M007
SennaSENNOSIDESAARNA USA INC.7ad21fb7-20eb-48d6-be15-450aa2ec97d32025-03-20WarningsExact identifier
application number: M007
CVS Health Stool Softener Plus stimulant laxative SoftgelDOCUSATE SODIUM, SENNOSIDESCVS Pharmacy, Inc2881d83d-9929-677a-e063-6394a90a04242025-03-19WarningsExact identifier
application number: M007
Mineral OilMINERAL OILKesin Pharma Corporation30a11cc9-e407-23b7-e063-6294a90a7d6e2025-03-18WarningsExact identifier
application number: M007
CVS Magnesium Hydroxide Laxative ChewMAGNESIUM HYDROXIDECVS30126c74-6f5c-72f3-e063-6394a90ad81f2025-03-11WarningsExact identifier
application number: M007
Epsom SaltEPSOM SALTGood Sense (Geiss, Destin & Dunn, Inc.)c7a9f180-9c73-4317-adbe-f95702fb48022025-03-03WarningsExact identifier
application number: M007
Magnesium Citrate Saline LaxativeMAGNESIUM CITRATEAARNA USA INC.e7550220-df26-4a7a-a254-bebb225d9e5e2025-03-01WarningsExact identifier
application number: M007
Fiber laxativeCALCIUM POLYCARBOPHILDiscount Drug Mart, Inc2e0c4736-3d27-e088-e063-6294a90aeca82025-02-27WarningsExact identifier
application number: M007
Mineral oilMINERAL OILP & L Development, LLC68e88119-1468-4ab7-a5fa-242d960d25df2025-02-21WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEWhole Foods Market5a88048e-5417-4d8e-a149-f51610a5d4202025-02-19WarningsExact identifier
application number: M007
SennosidesSENNOSIDESPD-Rx Pharmaceuticals, Inc.829d24b7-a46a-4a29-88fe-180f35a2b6cd2025-02-18WarningsExact identifier
application number: M007
Stool Softener and Stimulant LaxativeDOCUSATE SODIUM, SENNOSIDESH-E-Bc19280c2-f968-b582-e053-2995a90a9bd32025-02-14WarningsExact identifier
application number: M007
STOOL SOFTENER-STIMULANT LAXATIVESTOOL SOFTENER-STIMULANT LAXATIVEKroger Companya22c9f95-e3a9-bfd3-e053-2995a90a3c662025-02-13WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN6484c373-697f-4a81-a375-8cb97223a42c3
1115005docusate sodium 100 MG Oral CapsuleSCD6484c373-697f-4a81-a375-8cb97223a42c3
1115005DOSS Sodium 100 MG Oral CapsuleSY6484c373-697f-4a81-a375-8cb97223a42c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-385-504903503855050 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49035-385-50) 2020-09-012026-12-28NoNoCurrent