Stool Softener

Product NDC
69618-086
11-digit product format
696180086
Labeler code
69618
Product ID
69618-086_44fae16b-d2fe-bf32-e063-6394a90a74b1
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Reliable 1 Laboratories LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-01
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

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
44fae161-3fc8-64c4-e063-6294a90a1d26Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-086-01Stool Softener100 in 1 BOTTLECAPSULE, LIQUID FILLED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-086-01EA - Each69618-086ed57a7b6-24b7-4ac3-bbb3-0671c65b527d12025-12-16

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 30 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna-LaxSENNOSIDESGuardian Drug Companyd3ee7288-986e-44a6-8aa2-05405210c8752024-12-19WarningsExact identifier
application number: M007
Quality Choice Stool SoftenerDOCUSATE SODIUMChain Drug Marketing Association4d5facd4-f57f-44f7-b8dd-83a33e57afd92024-12-18WarningsExact identifier
application number: M007
Good Neighbor Pharmacy Gentle LaxativeBISACODYLAmerisourceBergen Drug Corp8336d821-ec70-468e-98b2-512a9a7212e02024-12-18WarningsExact identifier
application number: M007
Good Neighbor Stool SoftenerDOCUSATE SODIUMAmerisourceBergen Drug Corp88d657a1-77be-412a-9295-034872db2dde2024-12-18WarningsExact identifier
application number: M007
Preferred Stool SoftenerDOCUSATE SODIUMReese Pharmaceutical Co217d13a0-3205-492c-af49-82eb80dba53a2024-12-18WarningsExact identifier
application number: M007
Preferred Stool SoftenerDOCUSATE CALCIUMReese Pharmaceutical Co3b481b74-5683-466f-ad74-3da63279ce912024-12-18WarningsExact identifier
application number: M007
Topcare Stool SoftenerDOCUSATE SODIUMTOPCO ASSOCIATES LLC9342c1b5-5d35-4b60-b347-c208c0774cdc2024-12-18WarningsExact identifier
application number: M007
HEB Stool SoftenerDOCUSATE SODIUMH E B3a513cb9-8404-43dc-a780-040bf9f1741d2024-12-18WarningsExact identifier
application number: M007
Topcare Stool Softener laxativeDOCUSATE SODIUMTOPCO ASSOCIATES LLCf9302fc2-684d-4cc2-bdd7-7ad0e9304edb2024-12-18WarningsExact identifier
application number: M007
Good Neighbor Stool Softener laxativeDOCUSATE SODIUMAmerisourceBergen Drug Corpd09151ae-1cc6-4e69-8d80-7813082a42362024-12-18WarningsExact identifier
application number: M007
Dollar General Gentle LaxativeBISACODYLDolgencorp, LLCf1977a2e-942a-49eb-8d0f-cdb67b020a262024-12-18WarningsExact identifier
application number: M007
Discount Drugmart Gentle LaxativeBISACODYLDiscount Drug Mart, Incb525a0a9-f97c-4406-8360-58e87e44cfce2024-12-18WarningsExact identifier
application number: M007
HEB Gentle LaxativeBISACODYLH E B3d163d71-93c7-419f-9707-5811aa6474fb2024-12-18WarningsExact identifier
application number: M007
Winco Stool SoftenerDOCUSATE SODIUMWinCo Foods, LLC4de2e315-5ec6-4ddf-8617-4e07ba4563542024-12-18WarningsExact identifier
application number: M007
Meijer Gentle LaxativeBISACODYLMeijer Distribution Inc.b49786a1-f0b9-45ae-b8f6-683489c54e762024-12-18WarningsExact identifier
application number: M007
H E B Stool Softener laxativeDOCUSATE SODIUMH E B9d848fdd-3a2f-45c6-9ff3-17f1d74e0f4f2024-12-18WarningsExact identifier
application number: M007
Preferred Stool Softener laxativeDOCUSATE SODIUMReese Pharmaceutical Co9135addd-4fc7-411b-b3c3-79e7e0e4cec82024-12-18WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMDiscount Drug Mart, Inc80092188-0517-4646-bd46-ab56c63bb3542024-12-18WarningsExact identifier
application number: M007
Winco Stool SoftenerDOCUSATE SODIUMWinCo Foods, LLCd74c54d6-7a75-4ca9-8425-7593b7841b0f2024-12-18WarningsExact identifier
application number: M007
Quality Choice Stool Softener laxativeDOCUSATE SODIUMChain Drug Marketing Association7635b081-4350-45d0-b44e-82afccce21342024-12-18WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN44fae161-3fc8-64c4-e063-6294a90a1d261
1115005docusate sodium 100 MG Oral CapsuleSCD44fae161-3fc8-64c4-e063-6294a90a1d261
1115005DOSS Sodium 100 MG Oral CapsuleSY44fae161-3fc8-64c4-e063-6294a90a1d261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69618-086-0169618008601100 CAPSULE, LIQUID FILLED in 1 BOTTLE (69618-086-01) 2025-09-01NoNoCurrent