FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
0904-6997
Requested package NDC
0904-6997-40
11-digit product format
009046997
Labeler code
0904
Product ID
0904-6997_1ad9a5e9-bcbc-4fd6-b092-b92cf50e0ea9
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate calcium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-09-30
Marketing end
0000-00-00
Substance
DOCUSATE CALCIUM
Active strength
240 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0904-69970904-6997-40DDiscontinued by firm2026-08-03

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6997-40EA - Each0904-69974d83e65e-6ef2-4d0d-9a20-46b99ae0b08412021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6997STOOL SOFTENER LAXATIVE (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]4Legacy NDC20240413_40f14e88-015a-455c-82bb-30df683bb55a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-6997-4000904699740500 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0904-6997-40) 2019-09-300000-00-00NoNoCurrent