FDA.reportPublic FDA data

Stool Softener

Product NDC
69842-862
Requested package NDC
69842-862-10
11-digit product format
698420862
Labeler code
69842
Product ID
69842-862_51e5ab39-3077-4422-8d49-9666baf1519e
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
CVS Pharmacy
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-01-31
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69842-86269842-862-10DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-862-10Stool Softener100 in 1 BOTTLE, PLASTICCAPSULE1004
69842-862-25Stool Softener1 in 1 BOXCAPSULE14
69842-862-25Stool Softener25 in 1 BOTTLE, PLASTICCAPSULE254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-862-25EA - Each69842-8622637b6b5-46cc-4396-94ac-d749099aef7f12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-862STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE [CVS PHARMACY]4Legacy NDC, 3 package rows20240308_89d2e4cf-b6f6-4c96-97bb-2e4b3dc852c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN89d2e4cf-b6f6-4c96-97bb-2e4b3dc852c74
1115005docusate sodium 100 MG Oral CapsuleSCD89d2e4cf-b6f6-4c96-97bb-2e4b3dc852c74
1115005DOSS Sodium 100 MG Oral CapsuleSY89d2e4cf-b6f6-4c96-97bb-2e4b3dc852c74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-862-1069842086210100 CAPSULE in 1 BOTTLE, PLASTIC (69842-862-10) 100 capsule2020-01-310000-00-00NoNoCurrent