FDA.reportPublic FDA data

Stool Softener

Product NDC
69842-879
11-digit product format
698420879
Labeler code
69842
Product ID
69842-879_108821ce-5708-45ba-88dc-70551fa8385e
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
2019-09-30
Substance
DOCUSATE SODIUM
Active strength
250 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
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM250 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
1245468Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dcd27653-4c81-4630-a8b7-5fb5dc3e976aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-879-25Stool SoftenerExtra Strength250 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2505
69842-879-50Stool SoftenerExtra Strength500 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED5005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-879STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CVS PHARMACY]5Current NDC, Legacy NDC, 2 package rows20240315_dcd27653-4c81-4630-a8b7-5fb5dc3e976a.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 9 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener plus Stimulant LaxativeDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGCARDINAL HEALTH, 110 DBA LEADER3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce2026-03-06WarningsExact identifier
application number: M007
Magnesium CitrateEQUATE MAGNESIUM CITRATE ORAL SOLUTION - LEMONWalmart Inc.484d0421-59ea-3783-e063-6394a90af6332026-03-04WarningsExact identifier
application number: M007
Magnesium CitrateEQUATE MAGNESIUM CITRATE ORAL SOLUTION - CHERRYWalmart Inc.484c2586-9e6f-1ce5-e063-6394a90a0d812026-03-04WarningsExact identifier
application number: M007
Magnesium CitrateEQUATE MAGNESIUM CITRATE ORAL SOLUTION - GRAPEWalmart Inc.450ddcbd-7ccd-3670-e063-6294a90ac2bd2026-03-04WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEAmazon.com Services LLC787ec4b0-c6c5-44ab-a53d-d6d25304f95e2026-03-03Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEOld East Main Co.3d0d63d7-640d-4e54-a6fd-6b265c79be092026-03-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEOld East Main Co.9b3b6cea-ab83-4b7c-a425-fd0ac7df426c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEOld East Main Co.51ed515b-cc51-4ea1-b612-0904761350052026-03-02Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEOld East Main Co.a8af6e2d-0052-4fc9-a51a-c9dbeb1ad3f52026-03-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEChain Drug Marketing Association629c5817-13b7-4527-8998-93131ee3529e2026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEChain Drug Marketing Association4df97cdc-e7a2-4350-8f95-a679cdcaff642026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEChain Drug Marketing Association46b26b44-e065-4337-a071-fa036f8971402026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEChain Drug Marketing Associationef163b24-ce92-4cbc-b45a-4fae3b5119492026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEChain Drug Marketing Association4ee26633-8eb1-4c68-a768-20460404533a2026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILChain Drug Marketing Association3bfdad9c-ac58-4e92-b952-555e8a8351cd2026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEThe Kroger Co.2bcab227-42b6-4bff-8363-f6800665755b2026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEThe Kroger Co.a87dceb2-da73-4d3a-b87c-db2af10471bf2026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Kroger Co.3ae7e275-7bbc-4e62-b30f-013c40a899492026-02-27WarningsExact identifier
application number: M007
SennosidesSENNOSIDESCVS Pharmacy, Inc0b7736df-c7de-7d00-e063-6294a90aa57e2026-02-26WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMPD-Rx Pharmaceuticals, Inc.5d300ea7-78eb-4e19-8333-1e42c73c4c542026-02-26WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245468docusate sodium 250 MG Oral CapsulePSNdcd27653-4c81-4630-a8b7-5fb5dc3e976a5
1245468docusate sodium 250 MG Oral CapsuleSCDdcd27653-4c81-4630-a8b7-5fb5dc3e976a5
1245468DOSS Sodium 250 MG Oral CapsuleSYdcd27653-4c81-4630-a8b7-5fb5dc3e976a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-879-2569842087925250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-879-25) 2019-09-300000-00-00NoNoCurrent
69842-879-5069842087950500 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-879-50) 2019-09-300000-00-00NoNoCurrent