FDA.reportPublic FDA data

Quality Choice Stool Softener

Product NDC
83324-197
11-digit product format
833240197
Labeler code
83324
Product ID
83324-197_6d726c03-d7d2-427a-8fea-80e2f38b4745
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-02
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
Quality Choice 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
b1440ab7-a7d5-4153-8143-cffad73120f5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-197-01Quality Choice Stool Softener100 in 1 BOTTLECAPSULE, LIQUID FILLED1001
83324-197-25Quality Choice Stool Softener250 in 1 BOTTLECAPSULE, LIQUID FILLED2501

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 7 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sennosides, Docusate SodiumSENNOSIDES, DOCUSATE SODIUMCardinal Health 107, LLC1a21b07a-263c-41a4-ba0c-ad2dc5a295d72026-05-05WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED4842a767-bb12-9d85-e063-6294a90a19b52026-04-27WarningsExact identifier
application number: M007
Alcohol wet wipesALCOHOL WET WIPESShandong Aishule Hygiene Products Co., Ltdf79dbac0-cec0-46bc-e053-6294a90a2b132026-04-25WarningsExact identifier
application number: M007
Sterilized wet wipesSTERILIZED WET WIPESShandong Aishule Hygiene Products Co., Ltdf7ca1799-eee4-66f0-e053-6294a90a273f2026-04-25WarningsExact identifier
application number: M007
Wet wipesWET WIPESJINGXIN GROUP (M) SDN BHD395225b1-486b-1867-e063-6394a90a18652026-04-25WarningsExact identifier
application number: M007
Sterilized wet wipesSTERILIZED WET WIPESJINGXIN GROUP (M) SDN BHD3952873e-5e3f-1bff-e063-6294a90a8a622026-04-25WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMPublix Supermarkets, Inc.ed50555f-b105-45c8-9dc4-1bd4d233a1e32026-04-23WarningsExact identifier
application number: M007
Mineral OilMINERAL OILPublix Supermarkets, Inc.382a57d1-85bf-480f-9967-f85da29044102026-04-23WarningsExact identifier
application number: M007
BISACODYLBISACODYLAARNA USA INC.50109967-69af-5fc5-e063-6394a90a87512026-04-22WarningsExact identifier
application number: M007
SennaSENNARugby Laboratories41d53783-7ac2-411c-b9bf-afd87b3af30d2026-04-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFI95bae7bf-f240-4674-9e3c-640a603fdc352026-04-15WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEPublix Super Markets, Inc.a4b442f1-d5a6-4cbf-b371-1f6639634f802026-04-13Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEPublix Super Markets, Inc.267c434d-3034-491b-b4b1-1d0cbacb16152026-04-13Warnings, Adverse reactionsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackd616685a-11fc-4ae0-80de-7d25c0d71ee92026-04-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMH E B84116db2-a7b7-460a-a5e5-8558bd4247812026-04-02WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEAmerican Health Packaging7d7d789b-b2e7-4600-a025-0cd2ff5b36722026-04-02WarningsExact identifier
application number: M007
Castor OilCASTOR OILSTRATEGIC SOURCING SERVICES4db6736f-416a-f142-e063-6394a90ab08f2026-04-01WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEFarmacias De Similares TX LLC4e6a64a0-e453-709b-e063-6294a90a74432026-04-01WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMMajor Pharmaceuticals93ef6486-0930-41e3-a2c6-44af7e37e98b2026-03-31WarningsExact identifier
application number: M007
Senna SyrupNATURAL VEGETABLE LAXATIVEBryant Ranch Prepack2c0d62e7-563b-46e4-9793-183e98e761a62026-03-25WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNb1440ab7-a7d5-4153-8143-cffad73120f51
1115005docusate sodium 100 MG Oral CapsuleSCDb1440ab7-a7d5-4153-8143-cffad73120f51
1115005DOSS Sodium 100 MG Oral CapsuleSYb1440ab7-a7d5-4153-8143-cffad73120f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-197-0183324019701100 CAPSULE, LIQUID FILLED in 1 BOTTLE (83324-197-01) 2025-12-02NoNoCurrent
83324-197-2583324019725250 CAPSULE, LIQUID FILLED in 1 BOTTLE (83324-197-25) 2025-12-02NoNoCurrent