FDA.reportPublic FDA data

DocuSol

Product NDC
17433-9878
Requested package NDC
17433-9878-5
11-digit product format
174339878
Labeler code
17433
Product ID
17433-9878_ecfb3572-aff3-375f-e053-2995a90ad328
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium
Dosage form
LIQUID
Route
RECTAL
Labeler
Enemeez LLC DBA Summit Pharmaceuticals
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-07-08
Marketing end
2024-10-31
Substance
DOCUSATE SODIUM
Active strength
283 mg/5mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage17433-987817433-9878-5DDiscontinued 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 · 10 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…

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
17433-9878-32023-01-13C16284748780-19d75b9d0-2d8e-f424-e053-dadaa90a57ce1235366d-b572-3a41-e054-00144ff8d46c
17433-9878-32020-01-31C16284748780-19d75b9d0-2d8e-f424-e053-dadaa90a57ce1235366d-b572-3a41-e054-00144ff8d46c

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17433-9878-1EA - Each17433-9878bec574c2-ca74-46b5-bf9a-34ee462aed7012016-01-13
17433-9878-5EA - Each17433-98783e4b22f5-0f85-42c5-b015-d4c7beb48ad112013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSOL (DOCUSATE SODIUM) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]2
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSOL (DOCUSATE SODIUM) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSOL (DOCUSATE SODIUM) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSOL (DOCUSATE SODIUM) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]2
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSOL (DOCUSATE SODIUM) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]1
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSOL (DOCUSATE SODIUM) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSOL (DOCUSATE SODIUM) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSOL (DOCUSATE SODIUM) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17433-9878-5174339878055 TUBE in 1 BOX (17433-9878-5) > 5 mL in 1 TUBE (17433-9878-1) 5 tube2013-07-082024-10-31NoNoCurrent