Stool Softener

Product NDC
68196-853
11-digit product format
681960853
Labeler code
68196
Product ID
68196-853_d737c0ad-f89f-4b67-94cd-6837dd086ab0
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Sam's West, Inc
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-28
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
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
b14d2495-1092-4063-869f-73a7e8c28708Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68196-853-602023-05-09C16284748780-1f386c64a-1c5f-0266-e053-dadaa90a7c1aDrug Facts
68196-853-602023-01-30C16284748780-1f386c64a-1c5f-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-853-60Stool Softener600 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED6003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-853STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC]3Current NDC, Legacy NDC, 1 package rows20240522_b14d2495-1092-4063-869f-73a7e8c28708.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 CapsulePSNb14d2495-1092-4063-869f-73a7e8c287083
1115005docusate sodium 100 MG Oral CapsuleSCDb14d2495-1092-4063-869f-73a7e8c287083
1115005DOSS Sodium 100 MG Oral CapsuleSYb14d2495-1092-4063-869f-73a7e8c287083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68196-853-6068196085360600 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68196-853-60) 2021-05-280000-00-00NoNoCurrent