FDA.reportPublic FDA data

STOOL SOFTENER AND STIMULANT LAXATIVE

Product NDC
70000-0442
Requested package NDC
70000-0442-1
11-digit product format
700000442
Labeler code
70000
Product ID
70000-0442_edc408cf-9cc7-1550-e053-2995a90ad447
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM AND SENNOSIDES
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Cardinal Health
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-01-30
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70000-044270000-0442-1DDiscontinued by firm2026-10-12

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
70000-0442-1STOOL SOFTENER AND STIMULANT LAXATIVE1 in 1 CARTONCAPSULE, GELATIN COATED18
70000-0442-1STOOL SOFTENER AND STIMULANT LAXATIVE60 in 1 BOTTLE, PLASTICCAPSULE, GELATIN COATED608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0442-1EA - Each70000-0442fdb49bc1-e7ea-4562-80b8-0715227258ba12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0442STOOL SOFTENER AND STIMULANT LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) CAPSULE, GELATIN COATED [CARDINAL HEALTH]7Legacy NDC, 2 package rows20241215_333cd1db-f313-4e5d-b1b9-c4a5290519a5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0442-1700000442011 BOTTLE, PLASTIC in 1 CARTON (70000-0442-1) > 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC2019-01-300000-00-00NoNoCurrent