EXTRA STRENGTH STOOL SOFTENER LAXATIVE

Product NDC: 0536-3757
11-digit product format: 005363757
Labeler code: 0536
Product ID: 0536-3757_487cc305-09ae-4773-b2fe-3a3f471f4f82
Type: HUMAN OTC DRUG
Nonproprietary name: DOCUSATE SODIUM
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Rugby Laboratories, Inc.
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-03-29
Marketing end: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0536-3757		D	Discontinued by firm	2026-08-11
excluded package	package	0536-3757	0536-3757-01	D	Discontinued by firm	2026-08-11
excluded package	package	0536-3757	0536-3757-10	D	Discontinued by firm	2026-08-11

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 · 36 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0536-3757-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0536-3757-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0536-3757-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0536-3757-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0536-3757-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0536-3757-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0536-3757-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0536-3757-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0536-3757-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0536-3757-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0536-3757-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0536-3757-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0536-3757-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0536-3757-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0536-3757-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0536-3757-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0536-3757-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0536-3757-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0536-3757-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0536-3757-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0536-3757-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0536-3757-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0536-3757-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0536-3757-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
0536-3757-01	EA - Each	0536-3757	23d24866-d12b-450b-a459-ab8303d4f55b	1	2012-07-24
0536-3757-10	EA - Each	0536-3757	02cdaa8e-822a-4c24-874d-a5e3dba9bfdc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]	1000
DOCUSATE	ACTIVE MOIETY	M7P27195AG	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]	1000
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]	1000
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]	1000
GELATIN	INACTIVE INGREDIENT	2G86QN327L	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]	1000
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]	1000
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]	1000
SORBITOL	INACTIVE INGREDIENT	506T60A25R	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]	1000
WATER	INACTIVE INGREDIENT	059QF0KO0R	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]	1000
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]	8
DOCUSATE	ACTIVE MOIETY	M7P27195AG	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]	8
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]	8
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]	8
SORBITOL	INACTIVE INGREDIENT	506T60A25R	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]	8
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAPAK SERVICES, LLC]	1
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [DISPENSING SOLUTIONS, INC.]	1
DOCUSATE	ACTIVE MOIETY	M7P27195AG	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAPAK SERVICES, LLC]	1
DOCUSATE	ACTIVE MOIETY	M7P27195AG	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [DISPENSING SOLUTIONS, INC.]	1
DOCUSATE	ACTIVE MOIETY	M7P27195AG	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAPAK SERVICES, LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [DISPENSING SOLUTIONS, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAPAK SERVICES, LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [DISPENSING SOLUTIONS, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [DISPENSING SOLUTIONS, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAPAK SERVICES, LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [DISPENSING SOLUTIONS, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAPAK SERVICES, LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAPAK SERVICES, LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [DISPENSING SOLUTIONS, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [DISPENSING SOLUTIONS, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAPAK SERVICES, LLC]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAPAK SERVICES, LLC]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [DISPENSING SOLUTIONS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAPAK SERVICES, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [DISPENSING SOLUTIONS, INC.]	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	9b68acea-9eb4-406a-8c0d-2cc7a9317d02	1
1245468	docusate sodium 250 MG Oral Capsule	PSN	e05cd4e1-e2e9-450f-9371-30eddd35006d	1
1245468	docusate sodium 250 MG Oral Capsule	SCD	9b68acea-9eb4-406a-8c0d-2cc7a9317d02	1
1245468	docusate sodium 250 MG Oral Capsule	SCD	e05cd4e1-e2e9-450f-9371-30eddd35006d	1
1245468	DOSS Sodium 250 MG Oral Capsule	SY	9b68acea-9eb4-406a-8c0d-2cc7a9317d02	1
1245468	DOSS Sodium 250 MG Oral Capsule	SY	e05cd4e1-e2e9-450f-9371-30eddd35006d	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Rugby Laboratories, Inc. \| P & L Development, LLC	2018-12-20	HUMAN OTC DRUG LABEL	9
Docusate Sodium 250mg - Relabeled Product	Aidapak Services, LLC	2014-10-10	HUMAN OTC DRUG LABEL	1
Drug Facts	State of Florida DOH Central Pharmacy	2014-03-03	HUMAN OTC DRUG LABEL	1
Rugby Extra Strength Stool Softener Laxative	Bryant Ranch Prepack	2013-02-13	HUMAN OTC DRUG LABEL	1000
Docusate Sodium ES	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-09-14	HUMAN OTC DRUG LABEL	1