FDA.reportPublic FDA data

Gentle Stool softener

Product NDC
11822-1574
11-digit product format
118221574
Labeler code
11822
Product ID
11822-1574_ece75b01-2926-b135-e053-2995a90a13e1
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
RITE AID CORPORATION
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-11-07
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 productproduct11822-1574IInactivated by FDA2026-10-12
excluded packagepackage11822-157411822-1574-5IInactivated 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
11822-1574-5Gentle Stool softener1 in 1 CARTONCAPSULE, LIQUID FILLED15
11822-1574-5Gentle Stool softener50 in 1 BOTTLECAPSULE, LIQUID FILLED505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1574GENTLE STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RITE AID CORPORATION]5Legacy NDC, 2 package rows20250101_34ac244f-c231-44d1-9ddb-9c2e8a709d27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN34ac244f-c231-44d1-9ddb-9c2e8a709d275
1115005docusate sodium 100 MG Oral CapsuleSCD34ac244f-c231-44d1-9ddb-9c2e8a709d275
1115005DOSS Sodium 100 MG Oral CapsuleSY34ac244f-c231-44d1-9ddb-9c2e8a709d275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-1574-5118221574051 BOTTLE in 1 CARTON (11822-1574-5) > 50 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-11-070000-00-00NoNoCurrent