FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
69842-782
11-digit product format
698420782
Labeler code
69842
Product ID
69842-782_45f92987-a003-4258-a2ca-e62060a17887
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS Pharmacy
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-05
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
f77c65b0-3e13-48ce-a2d9-36a9eba1851fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-782-10Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1006
69842-782-25Stool Softener Laxative250 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2506
69842-782-30Stool Softener Laxative30 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED306
69842-782-40Stool Softener Laxative400 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED4006
69842-782-75Stool Softener Laxative750 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED7506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-782STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CVS PHARMACY]6Current NDC, Legacy NDC, 5 package rows20240308_f77c65b0-3e13-48ce-a2d9-36a9eba1851f.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 18 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHILLIPS FRESH MINT MILK OF MAGNESIAPHILLIPS FRESH MINT MILK OF MAGNESIABayer HealthCare LLC.0a59f9c3-c14e-2824-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M007
CVS Mini EnemaDOCUSATE SODIUM W/BENZOCAINECVS HEALTHca00c520-410a-1905-e053-2995a90a56f02025-12-04WarningsExact identifier
application number: M007
Docusate Mini EnemaDOCUSATE SODIUMMajor Pharmaceuticals91099e15-94d7-b684-e053-2a95a90a574e2025-12-04WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp1057c0bf-4bf6-ea17-e063-6294a90a59842025-12-04WarningsExact identifier
application number: M007
PHILLIPS ORIGINAL MILK OF MAGNESIAPHILLIPS ORIGINAL MILK OF MAGNESIABayer HealthCare LLC.0a57bb45-d4f7-443b-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M007
Equalactin LaxativeCALCIUM POLYCARBOPHILNUMARK BRANDS, INC2feed33a-3b7f-11c6-6e62-c99150ecfddd2025-12-03WarningsExact identifier
application number: M007
Gentle Laxative Stimulant LaxativeBISACODYLQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)bcd3c07d-bd83-4452-9736-35c85db30c152025-12-03WarningsExact identifier
application number: M007
Quality Choice Fiber LaxativePSYLLIUM HUSKQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)2ee637c4-c4c6-4a24-ae99-612205afd5922025-12-03WarningsExact identifier
application number: M007
Quality ChoiceCALCIUM POLYCARBOPHILQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f1e69c65-c1b0-459f-9a12-b1a92b90036b2025-12-03WarningsExact identifier
application number: M007
CDMA Fiber TherapyMETHYLCELLULOSECHAIN DRUG MARKETING ASSOCIATION62bbcaf2-1d0c-485f-9159-685700aa34182025-12-03WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMReliable 1 Laboratories LLC44fae161-3fc8-64c4-e063-6294a90a1d262025-12-02WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMRMT HEALTH LLC44fbb197-fe90-c5a8-e063-6394a90adb7d2025-12-02WarningsExact identifier
application number: M007
Fiber LaxCALCIUM POLYCARBOPHILRugby Laboratories318d81ed-0b06-4d21-8b97-2d1f0267c7812025-12-02WarningsExact identifier
application number: M007
Magnesium CitrateEPIC MEDICAL MAGNESIUM CITRATE ORAL SOLUTION - LEMON4 Visions LLC44fe65d0-ee46-1d95-e063-6294a90abb712025-12-02WarningsExact identifier
application number: M007
FIBER TABSCALCIUM POLYCARBOPHILMajor Pharmaceuticalsbee100da-b9c9-4261-b6e6-7b3db57156252025-12-02WarningsExact identifier
application number: M007
Quality Choice Stool SoftenerDOCUSATE SODIUMChain Drug Marketing Associationb1440ab7-a7d5-4153-8143-cffad73120f52025-12-02WarningsExact identifier
application number: M007
Walgreen Fiber LaxCALCIUM POLYCARBOPHILWALGREENS CO.9cbe1798-e0dc-4a90-bd91-8696fc59b2a62025-11-25WarningsExact identifier
application number: M007
Walgreens Fiber TherapyMETHYLCELLULOSEWALGREENS CO.6401a2c3-5869-4898-81db-3cd7151ca69a2025-11-25WarningsExact identifier
application number: M007
Walgreens Senna LaxativeSENNOSIDESWALGREENS CO.a95bd796-d85e-4599-bbb1-2170088fa9372025-11-25WarningsExact identifier
application number: M007
Walgreens Stool Softener Fruit PunchDOCUSATE SODIUMWALGREENS CO.8428c81d-227a-4b0f-9a47-71d6a69838422025-11-25WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNf77c65b0-3e13-48ce-a2d9-36a9eba1851f6
1115005docusate sodium 100 MG Oral CapsuleSCDf77c65b0-3e13-48ce-a2d9-36a9eba1851f6
1115005DOSS Sodium 100 MG Oral CapsuleSYf77c65b0-3e13-48ce-a2d9-36a9eba1851f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-782-1069842078210100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-782-10) 2021-02-050000-00-00NoNoCurrent
69842-782-2569842078225250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-782-25) 2021-02-050000-00-00NoNoCurrent
69842-782-306984207823030 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-782-30) 2021-02-050000-00-00NoNoCurrent
69842-782-4069842078240400 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-782-40) 2021-02-050000-00-00NoNoCurrent
69842-782-7569842078275750 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-782-75) 2021-02-050000-00-00NoNoCurrent