FDA.reportPublic FDA data

Docusate Sodium

Product NDC
72789-295
Requested package NDC
72789-295-30
11-digit product format
727890295
Labeler code
72789
Product ID
72789-295_f082acf2-6258-7499-e053-2995a90ae20d
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-05-28
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
100 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 packagepackage72789-29572789-295-30DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-295-30EA - Each72789-2953698d9bd-6883-4708-be78-df0ecc6fb90c12023-02-06
72789-295-90EA - Each72789-2951464b7e7-ddb8-4b56-9873-49bbfe2bcdfd12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-295DOCUSATE SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]6Legacy NDC20240720_2d657c29-c701-4db0-9c06-f680bd921241.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-295-307278902953030 CAPSULE in 1 BOTTLE, PLASTIC (72789-295-30) 30 capsule2022-12-230000-00-00NoNoCurrent