Stool Softener Laxative

Product NDC: 11822-0584
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	11822-0584		D	Discontinued by firm		2026-10-12
excluded package	package	11822-0584	11822-0584-5	D	Discontinued by firm		2026-10-12

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	11822-0584-5	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	11822-0584-5	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	11822-0584-5	`bd6a592717d7…`	`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
Effective	Related label
2023-02-20	DRUG FACTS
2023-02-20	DRUG FACTS
2023-02-20	DRUG FACTS
2022-01-28	DRUG FACTS
2022-01-28	DRUG FACTS
2022-01-28	DRUG FACTS
2020-09-10	DRUG FACTS
2020-09-10	DRUG FACTS
2020-09-10	DRUG FACTS
2020-07-22	DRUG FACTS
2020-07-22	DRUG FACTS
2020-07-22	DRUG FACTS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-0584	STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE [RITE AID CORPORATION]	4	Legacy NDC	20240509_3593c39c-e8cb-4edb-a1d1-d49458652251.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F05Q2T2JA0	DOCUSATE SODIUM	577-11-7	DOCUSATE SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
11822-0584-5	11822058405	1 BOTTLE, PLASTIC in 1 BOX (11822-0584-5) > 50 CAPSULE in 1 BOTTLE, PLASTIC	2019-06-01	0000-00-00	No	No	Current