DOCUSATE SODIUM

Product NDC
68210-0350
11-digit product format
682100350
Labeler code
68210
Product ID
68210-0350_eea069a1-3e5a-fe59-e053-2a95a90a0927
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-10
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68210-0350IInactivated by FDA2026-10-12
excluded packagepackage68210-035068210-0350-1IInactivated by FDA2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-0350-1DOCUSATE SODIUM1 in 1 CARTONCAPSULE, LIQUID FILLED16
68210-0350-1DOCUSATE SODIUM100 in 1 BOTTLECAPSULE, LIQUID FILLED1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-0350DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]6Legacy NDC, 2 package rows20241215_69ca6847-bb21-4b16-917e-caf7fe98a5f8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-0350-1682100350011 BOTTLE in 1 CARTON (68210-0350-1) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-03-100000-00-00NoNoCurrent