Stool Softener Laxative

Product NDC
41163-862
11-digit product format
411630862
Labeler code
41163
Product ID
41163-862_4d26424e-ff0f-48bd-a90a-09f54f64c928
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-31
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
b1d903a5-1d5f-44d4-9939-a4b86e5a620dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-862-25Stool Softener Laxative25 in 1 BOTTLE, PLASTICCAPSULE253
41163-862-25Stool Softener Laxative1 in 1 BOXCAPSULE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-862STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE [UNITED NATURAL FOODS, INC. DBA UNFI]3Current NDC, Legacy NDC, 2 package rows20240524_b1d903a5-1d5f-44d4-9939-a4b86e5a620d.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 41 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWal-Mart Stores, Inc.750e0355-369e-b679-e053-2a91aa0a66ca2023-11-01WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWal-Mart Stores, Inc.750efd58-5845-fbc4-e053-2a91aa0a86d12023-11-01WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEWALGREEN COMPANYba4a29b3-2ddc-b906-e053-2995a90a2ab72023-11-01WarningsExact identifier
application number: M007
DOCUZENSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGProficient Rx LP92879e62-f60a-4ab4-9532-610cdd2628ee2023-11-01WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions5999904a-6ac8-4d9e-951c-6e64e8cd93eb2023-11-01WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e98f9d9-679c-63a2-e053-2991aa0a4b8d2023-10-31WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e957b01-4f44-0a2a-e053-2991aa0a37a02023-10-31WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e993b13-8dc8-6653-e053-2a91aa0a4c2a2023-10-31WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDECVS3c8e4144-6702-2678-e054-00144ff88e882023-10-31WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILMagno-Humphries, Inc.9d22c208-d089-8b6a-e053-2995a90ab90a2023-10-27WarningsExact identifier
application number: M007
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.a0e6ab9b-fd31-45fd-93d5-b51d705c180a2023-10-27WarningsExact identifier
application number: M007
Sennosides Natural LaxativeSENNOSIDESMagno-Humphries, Inc.9d22bedb-9fca-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
application number: M007
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.9d22d642-8aed-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM, SENNOSIDESMagno-Humphries, Inc.9deaf264-6af0-40ba-e053-2a95a90ada0e2023-10-27WarningsExact identifier
application number: M007
FLEETMINERAL OILC.B. Fleet Company, Inc.2528cb5e-437e-41f0-9c34-e9ce57404d8b2023-10-26WarningsExact identifier
application number: M007
Magnesium CitrateMAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMONMajor Pharmaceuticals088e5543-c947-af78-e063-6294a90a8bc42023-10-25WarningsExact identifier
application number: M007
DOKDOCUSATE SODIUMMAJOR PHARMACEUTICALS7a92070d-98cc-662f-e053-2991aa0aa1b22023-10-23WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMKROGER COMPANYa1afaa71-7e8c-5a49-e053-2a95a90a4db02023-10-23WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp644d81ec-d38f-4172-a087-727b94e2fefe2023-10-19WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAsclemed USA, Inc.30fc8c07-c26b-4bcc-a727-6e193f5727fd2023-10-16WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNb1d903a5-1d5f-44d4-9939-a4b86e5a620d3
1115005docusate sodium 100 MG Oral CapsuleSCDb1d903a5-1d5f-44d4-9939-a4b86e5a620d3
1115005DOSS Sodium 100 MG Oral CapsuleSYb1d903a5-1d5f-44d4-9939-a4b86e5a620d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41163-862-25411630862251 BOTTLE, PLASTIC in 1 BOX (41163-862-25) / 25 CAPSULE in 1 BOTTLE, PLASTIC2020-01-310000-00-00NoNoCurrent