FDA.reportPublic FDA data

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 42 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener Extra StrengthDOCUSATE SODIUMMEIJER, INC.e43bd2ed-17c7-4530-af72-81a7ad70069c2023-10-12WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCare One (Retail Business Services, LLC.)9adaec97-43e3-48f2-96c8-c508b693676c2023-10-05WarningsExact identifier
application number: M007
Senna LaxSENNOSIDES 8.6MGTopCo Associates, LLC83aeb90a-ab00-4e26-aa44-5259dce590182021-04-28WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAllegiant Health9fbe783e-ddd9-445a-852a-00f4ad7548802021-04-20WarningsExact identifier
application number: M007
Topcare Stool SoftenerDOCUSATE SODIUMTopCo Associates, LLC6f4fddda-4129-4087-b0e4-ababc55584842021-02-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAllegiant Health30c9ff75-cee4-4632-86fd-acfdf5ee85af2020-10-27WarningsExact identifier
application number: M007
Stool SoftenerMARC GLASSMANMarc Glassman, Inc.909cd222-d836-416f-aa7d-deb4a0c5a5602020-09-08WarningsExact identifier
application number: M007
Senna LaxSENNOSIDES 8.6MGAllegiant Health94a9c24a-07c3-4535-b810-b7abc9fc5ad52019-12-11WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGMarc Glassman, Inc.ec34fc1e-d122-4fa4-859e-e89e3e12edd52019-09-18WarningsExact identifier
application number: M007
Womens LaxativeBISACODYLMarc Glassman, Inc.aeb3c49b-cbf5-4a47-b19c-e77fbb987a492019-09-17WarningsExact identifier
application number: M007
Bisacodyl 5mgBISACODYL 5MGAllegiant Health46a377f5-822b-496f-a73b-66d8f902680a2019-03-26WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGAllegiant Health51f1c6c0-770c-4426-820b-bc1f42e143fd2019-02-07WarningsExact identifier
application number: M007
Senna-LaxSENNOSIDESMarc Glassman, Inc.7dd97c54-2ba1-4629-87b9-1ba0913fe5312016-12-27WarningsExact 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