FDA.reportPublic FDA data

Stool Softener plus Stimulant Laxative

Product NDC
37808-084
11-digit product format
378080084
Labeler code
37808
Product ID
37808-084_fb9b0f28-b255-498b-b75b-362dc00cd6ed
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
H E B
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-04-30
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37808-084DDiscontinued by firm2026-10-12
excluded packagepackage37808-08437808-084-12DDiscontinued by firm2026-10-12
excluded packagepackage37808-08437808-084-24DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37808-084-122023-02-11Drug Facts
37808-084-242023-02-11Drug Facts
37808-084-122023-01-30Drug Facts
37808-084-242023-01-30Drug Facts
37808-084-122021-04-20Drug Facts
37808-084-242021-04-20Drug Facts
37808-084-122021-01-29Drug Facts
37808-084-242021-01-29Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-084STOOL SOFTENER PLUS STIMULANT LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [H E B]7Legacy NDC20230213_d0ec5647-f199-4673-b66f-54380e746eef.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-084-1237808008412120 TABLET in 1 BOTTLE, PLASTIC (37808-084-12) 120 tablet2016-04-300000-00-00NoNoCurrent
37808-084-2437808008424240 TABLET in 1 BOTTLE, PLASTIC (37808-084-24) 240 tablet2016-04-300000-00-00NoNoCurrent