Stool Softener plus Laxative

Product NDC
63868-137
Requested package NDC
63868-137-60
11-digit product format
638680137
Labeler code
63868
Product ID
63868-137_5202a0fe-e095-4377-882e-3f61527200f3
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM, SENNOSIDES
Dosage form
TABLET
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-11-30
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 packagepackage63868-13763868-137-60DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-137-602024-01-30C16284748780-11030e365-2c14-111a-e063-dadaa90a10e2DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-137-60Stool Softener plus Laxative1 in 1 BOXTABLET14
63868-137-60Stool Softener plus Laxative60 in 1 BOTTLETABLET604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-137-60EA - Each63868-13786faf8cf-b278-4500-a62e-2bd28bc6ac1b12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-137STOOL SOFTENER PLUS LAXATIVE (DOCUSATE SODIUM, SENNOSIDES) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4Legacy NDC, 2 package rows20221109_6dbf9db3-7489-458b-ba20-69dd38a0e40c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN6dbf9db3-7489-458b-ba20-69dd38a0e40c4
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD6dbf9db3-7489-458b-ba20-69dd38a0e40c4
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY6dbf9db3-7489-458b-ba20-69dd38a0e40c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-137-60638680137601 BOTTLE in 1 BOX (63868-137-60) > 60 TABLET in 1 BOTTLE1 bottle2015-11-300000-00-00NoNoCurrent