FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
11822-0584
Requested package NDC
11822-0584-5
11-digit product format
118220584
Labeler code
11822
Product ID
11822-0584_6e516683-2acc-4da8-b0a0-4f0c3afe0281
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
2019-06-01
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage11822-058411822-0584-5DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage11822-058411822-0584-5IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage11822-058411822-0584-5IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage11822-058411822-0584-5IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-02-20DRUG FACTS
2023-02-20DRUG FACTS
2023-02-20DRUG FACTS
2022-01-28DRUG FACTS
2022-01-28DRUG FACTS
2022-01-28DRUG FACTS
2020-09-10DRUG FACTS
2020-09-10DRUG FACTS
2020-09-10DRUG FACTS
2020-07-22DRUG FACTS
2020-07-22DRUG FACTS
2020-07-22DRUG FACTS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0584STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE [RITE AID CORPORATION]4Legacy NDC20240509_3593c39c-e8cb-4edb-a1d1-d49458652251.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11822-0584-5118220584051 BOTTLE, PLASTIC in 1 BOX (11822-0584-5) > 50 CAPSULE in 1 BOTTLE, PLASTIC2019-06-010000-00-00NoNoCurrent