FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
11822-6328
11-digit product format
118226328
Labeler code
11822
Product ID
11822-6328_49c6cb23-812a-4dd2-a1a5-99b8ced2f5be
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
Rite Aid Corporation
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-29
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct11822-6328DDiscontinued by firm2026-10-20
excluded packagepackage11822-632811822-6328-3DDiscontinued by firm2026-10-20

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-6328-32023-02-20C16284748780-1f386c64a-3621-0266-e053-dadaa90a7c1aDRUG FACTS
11822-6328-32023-01-30C16284748780-1f386c64a-3621-0266-e053-dadaa90a7c1aDRUG FACTS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-6328STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE [RITE AID CORPORATION]3Legacy NDC20230221_bb6153a5-ad26-4c79-a3db-5c928a0a768e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11822-6328-3118226328031 BOTTLE, PLASTIC in 1 BOX (11822-6328-3) > 25 CAPSULE in 1 BOTTLE, PLASTIC2020-05-290000-00-00NoNoCurrent