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 8 of 43 · 858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna SyrupNATURAL VEGETABLE LAXATIVEBryant Ranch Prepack2c0d62e7-563b-46e4-9793-183e98e761a62026-03-25WarningsExact identifier
application number: M007
LaxomilBISACODYL 5MGPharmadel LLC3999935b-d8e8-52a6-e063-6294a90aa2a22026-03-20WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGGrocery Outletc820e6a1-fa23-447a-9ee9-50a1bd617adb2026-03-19WarningsExact identifier
application number: M007
CITRUCELMETHYLCELLULOSEHaleon US Holdings LLC9d5f2244-a610-4d45-b6e8-e79bb17a558f2026-03-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMSafeway, Inc.f178b31d-4843-4b91-a0d5-ab5ade835dc22026-03-16WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMSafeway, Inc.12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c2026-03-13WarningsExact identifier
application number: M007
Castor OilCASTOR OILOld East Main Co.a1ca668a-3bf9-46a9-8a4f-5cb61547bb812026-03-12Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILVi-Jon, LLCb29775df-8470-4fe3-bee3-f0490ea6903f2026-03-12WarningsExact identifier
application number: M007
Castor OilCASTOR OILNice-Pak Products, LLCcc43d514-ee82-4314-99b2-c64380f987792026-03-12Warnings, Adverse reactionsExact identifier
application number: M007
FiberconCALCIUM POLYCARBOPHILFoundation Consumer Brands7992a4bb-5535-4a1d-867d-a99f7e0c1be72026-03-12WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWalgreenscda27a9c-9175-4b07-9c0b-d8d8978829652026-03-12WarningsExact identifier
application number: M007
Magnesium Citrate Saline Laxative - Lemon FlavorMAGNESIUM CITRATEUniversal Distribution Center LLCaa02c9af-22b8-4ec2-9e43-fe073f5e617b2026-03-11WarningsExact identifier
application number: M007
Magnesium Citrate Saline Laxative - Grape FlavorMAGNESIUM CITRATEUniversal Distribution Center LLC021ebb61-2466-4272-8f7d-b49cafd087542026-03-11WarningsExact identifier
application number: M007
Magnesium Citrate Saline Laxative - Cherry FlavorMAGNESIUM CITRATEUniversal Distribution Center LLC1f14411b-6833-40e6-b1a5-2b8c5bf709d32026-03-11WarningsExact identifier
application number: M007
CitromaMAGNESIUM CITRATEUpLift Brands, LLCf83ba007-734d-4910-87cb-02e45285e1612026-03-11Warnings, Adverse reactionsExact identifier
application number: M007
CitromaMAGNESIUM CITRATEUpLift Brands, LLC57e914fa-8fa2-4221-bb5f-534f0ea0aba72026-03-11Warnings, Adverse reactionsExact identifier
application number: M007
CitromaMAGNESIUM CITRATEUpLift Brands, LLCf28a9043-e0ee-4b38-95d9-d3f23d4006912026-03-11Warnings, Adverse reactionsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAmerisource Bergen4caf0bcb-c1bf-0ae7-e063-6294a90a344b2026-03-10WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWalgreens92df761b-da68-4ce9-b02a-a5a74fd6620e2026-03-10WarningsExact identifier
application number: M007
FleetGLYCERINC.B. Fleet Company, Inc.31778652-e60e-4098-8e90-3e4f56b5800c2026-03-06WarningsExact 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