Stool Softener

Product NDC: 46122-263
Requested package NDC: 46122-263-78
11-digit product format: 461220263
Labeler code: 46122
Product ID: 46122-263_10ba126f-c935-47dc-8cd6-d967918dd930
Type: HUMAN OTC DRUG
Nonproprietary name: DOCUSATE SODIUM
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: AmerisourceBergen (Good Neighbor Pharmacy) 46122
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-05-01
Marketing end: 2022-12-31
Substance: DOCUSATE SODIUM
Active strength: 250 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	46122-263	46122-263-78	D	Discontinued by firm		2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46122-263-78	EA - Each	46122-263	5642722e-8191-449b-926c-4b911fcfb8f7	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]	1
DOCUSATE	ACTIVE MOIETY	M7P27195AG	STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]	1

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1245468	docusate sodium 250 MG Oral Capsule	PSN	011c8a4a-507a-472e-bc45-868011083ab0	5
1245468	docusate sodium 250 MG Oral Capsule	SCD	011c8a4a-507a-472e-bc45-868011083ab0	5
1245468	DOSS Sodium 250 MG Oral Capsule	SY	011c8a4a-507a-472e-bc45-868011083ab0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46122-263-78	46122026378	100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (46122-263-78)	2014-05-01	2022-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	AmerisourceBergen (Good Neighbor Pharmacy) 46122	2020-11-04	HUMAN OTC DRUG LABEL	4
Drug Facts	Atlantic Biologicals Corps	2019-09-25	HUMAN OTC DRUG LABEL	5