FDA.reportPublic FDA data

Stool Softener

Product NDC
49035-378
Requested package NDC
49035-378-14
11-digit product format
490350378
Labeler code
49035
Product ID
49035-378_6880d97d-63ec-4ddf-99f6-bb4fdc0c01d3
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-09-01
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
250 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 packagepackage49035-37849035-378-14DDiscontinued by firm2026-10-12

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
49035-378-14Stool SoftenerExtra Strength140 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-378-14EA - Each49035-378e18b81d9-9463-4baf-8d7b-3fc90857326e12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-378STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]4Legacy NDC, 1 package rows20240322_6cc9e30c-dd32-42b2-890c-a8e026ed0cca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245468docusate sodium 250 MG Oral CapsulePSN6cc9e30c-dd32-42b2-890c-a8e026ed0cca4
1245468docusate sodium 250 MG Oral CapsuleSCD6cc9e30c-dd32-42b2-890c-a8e026ed0cca4
1245468DOSS Sodium 250 MG Oral CapsuleSY6cc9e30c-dd32-42b2-890c-a8e026ed0cca4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-378-1449035037814140 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49035-378-14) 2020-09-010000-00-00NoNoCurrent