FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
11822-0652
11-digit product format
118220652
Labeler code
11822
Product ID
11822-0652_b7c9d7db-97ce-494e-b5b9-87606a98af46
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
2021-03-26
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11822-0652DDiscontinued by firm2026-10-20
excluded packagepackage11822-065211822-0652-0DDiscontinued by firm2026-10-20

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0652STOOL SOFTENER LAXATIVE EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RITE AID CORPORATION]4Legacy NDC20240509_de2d7062-5886-4d2a-be58-0d807364912e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11822-0652-011822065200100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (11822-0652-0) 2021-03-260000-00-00NoNoCurrent