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Product NDC
17433-9883
Requested package NDC
17433-9883-5
11-digit product format
174339883
Labeler code
17433
Product ID
17433-9883_ecfb3572-aff2-375f-e053-2995a90ad328
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium w/benzocaine
Dosage form
LIQUID
Route
RECTAL
Labeler
Enemeez LLC DBA Summit Pharmaceuticals
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-07-12
Marketing end
2024-10-31
Substance
BENZOCAINE; DOCUSATE SODIUM
Active strength
20 mg/5mL; mg/5mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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 packagepackage17433-988317433-9883-5DDiscontinued by firm2026-09-09

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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17433-9883-32023-01-13C16284748780-19d75b9d0-b2de-f424-e053-dadaa90a57ce1233853f-01b7-6305-e054-00144ff88e88
17433-9883-32020-01-31C16284748780-19d75b9d0-b2de-f424-e053-dadaa90a57ce1233853f-01b7-6305-e054-00144ff88e88

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17433-9883-1EA - Each17433-98838cfaf1ab-6d6b-497e-b24b-f60ec9a8880212016-01-13
17433-9883-5EA - Each17433-9883fddd1d31-33c7-4610-872b-6702160c072612013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5DOCUSOL PLUS (DOCUSATE SODIUM W/BENZOCAINE) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]5
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSOL PLUS (DOCUSATE SODIUM W/BENZOCAINE) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]5
BENZOCAINEACTIVE MOIETYU3RSY48JW5DOCUSOL PLUS (DOCUSATE SODIUM W/BENZOCAINE) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]5
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSOL PLUS (DOCUSATE SODIUM W/BENZOCAINE) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSOL PLUS (DOCUSATE SODIUM W/BENZOCAINE) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSOL PLUS (DOCUSATE SODIUM W/BENZOCAINE) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]5
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5DOCUSOL PLUS (DOCUSATE SODIUM W/BENZOCAINE) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]2
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSOL PLUS (DOCUSATE SODIUM W/BENZOCAINE) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]2
BENZOCAINEACTIVE MOIETYU3RSY48JW5DOCUSOL PLUS (DOCUSATE SODIUM W/BENZOCAINE) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]2
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSOL PLUS (DOCUSATE SODIUM W/BENZOCAINE) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSOL PLUS (DOCUSATE SODIUM W/BENZOCAINE) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSOL PLUS (DOCUSATE SODIUM W/BENZOCAINE) LIQUID [ENEMEEZ INC. DBA SUMMIT PHARMACEUTICALS]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17433-9883-5174339883055 TUBE in 1 BOX (17433-9883-5) > 5 mL in 1 TUBE (17433-9883-1) 5 tube2013-07-122024-10-31NoNoCurrent