FDA.reportPublic FDA data

Gentle Stool softener

Product NDC
11822-1573
11-digit product format
118221573
Labeler code
11822
Product ID
11822-1573_efe155a7-8d41-1c9d-e053-2995a90a09a5
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 productproduct11822-1573IInactivated by FDA2026-10-16
excluded packagepackage11822-157311822-1573-2IInactivated by FDA2026-10-16

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
11822-1573-2Gentle Stool softener1 in 1 CARTONCAPSULE, LIQUID FILLED15
11822-1573-2Gentle Stool softener25 in 1 BOTTLECAPSULE, LIQUID FILLED255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1573GENTLE STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RITE AID CORPORATION]5Legacy NDC, 2 package rows20250101_1c2c6ebd-f39e-4067-a753-295ea2d3f72d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN1c2c6ebd-f39e-4067-a753-295ea2d3f72d5
1115005docusate sodium 100 MG Oral CapsuleSCD1c2c6ebd-f39e-4067-a753-295ea2d3f72d5
1115005DOSS Sodium 100 MG Oral CapsuleSY1c2c6ebd-f39e-4067-a753-295ea2d3f72d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-1573-2118221573021 BOTTLE in 1 CARTON (11822-1573-2) > 25 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-11-070000-00-00NoNoCurrent