FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
36800-778
Requested package NDC
36800-778-10
11-digit product format
368000778
Labeler code
36800
Product ID
36800-778_ea00d6b4-36e9-4147-b9fc-5d4e280385f4
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-07-31
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage36800-77836800-778-10DDiscontinued by firm2026-10-12

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 · 9 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…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
36800-778-602023-11-15f386c649-e6b4-0266-e053-dadaa90a7c1aDrug Facts
36800-778-102023-10-17f386c64a-223e-0266-e053-dadaa90a7c1aDrug Facts
36800-778-252023-10-17f386c64a-223e-0266-e053-dadaa90a7c1aDrug Facts
36800-778-102023-01-30f386c64a-223e-0266-e053-dadaa90a7c1aDrug Facts
36800-778-252023-01-30f386c64a-223e-0266-e053-dadaa90a7c1aDrug Facts
36800-778-602023-01-30f386c649-e6b4-0266-e053-dadaa90a7c1aDrug Facts

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-778-1036800077810100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (36800-778-10) 2018-03-310000-00-00NoNoCurrent