FDA.reportPublic FDA data

STOOL SOFTENER

Product NDC
69842-319
11-digit product format
698420319
Labeler code
69842
Product ID
69842-319_edc546fd-187c-1793-e053-2995a90a143a
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM AND SENNOSIDES
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
CVS
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-03-15
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50 mg/1; 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69842-319IInactivated by FDA2026-10-12
excluded packagepackage69842-31969842-319-60IInactivated by FDA2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-319-60STOOL SOFTENER1 in 1 CARTONCAPSULE, GELATIN COATED18
69842-319-60STOOL SOFTENER60 in 1 BOTTLE, PLASTICCAPSULE, GELATIN COATED608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-319STOOL SOFTENER (DOCUSATE SODIUM AND SENNOSIDES) CAPSULE, GELATIN COATED [CVS]8Legacy NDC, 2 package rows20250101_271f134b-de73-415e-9c5e-a18267b765bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791612sennosides 8.6 MG / docusate sodium 50 MG Oral CapsulePSN271f134b-de73-415e-9c5e-a18267b765bc8
1791612docusate sodium 50 MG / sennosides, USP 8.6 MG Oral CapsuleSCD271f134b-de73-415e-9c5e-a18267b765bc8
1791612DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral CapsuleSY271f134b-de73-415e-9c5e-a18267b765bc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-319-60698420319601 BOTTLE, PLASTIC in 1 CARTON (69842-319-60) > 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC2018-03-150000-00-00NoNoCurrent