Senna and Docusate Sodium

Product NDC: 11534-134
11-digit product format: 115340134
Labeler code: 11534
Product ID: 11534-134_d08a4708-1de9-4bf4-8444-80d8942995b8
Type: HUMAN OTC DRUG
Nonproprietary name: Senna and Docusate Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sunrise Pharmaceutical Inc
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2007-07-26
Marketing end: 0000-00-00
Substance: DOCUSATE SODIUM; SENNOSIDES
Active strength: 50 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	11534-134		I	Inactivated by FDA	2026-09-14
excluded package	package	11534-134	11534-134-05	I	Inactivated by FDA	2026-09-14
excluded package	package	11534-134	11534-134-60	I	Inactivated by FDA	2026-09-14

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 2 · 63 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	11534-134-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11534-134-60	`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	11534-134-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11534-134-60	`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	11534-134-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11534-134-60	`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	11534-134-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11534-134-60	`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	11534-134-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11534-134-60	`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	11534-134-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11534-134-60	`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	11534-134-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11534-134-60	`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	11534-134-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11534-134-60	`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	11534-134-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11534-134-60	`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	11534-134-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11534-134-60	`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	11534-134-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11534-134-60	`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	11534-134-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11534-134-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	11534-134-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	11534-134-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	11534-134-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	11534-134-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	11534-134-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	11534-134-60	`1332a3947898…`	`d4bfe170f9cd…`
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	11534-134-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	11534-134-60	`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	11534-134-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	11534-134-60	`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	11534-134-05	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	11534-134-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	11534-134-05	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	11534-134-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	11534-134-05	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	11534-134-60	`e2bbac7714bc…`	`27bdfed8d636…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11534-134-05	2020-01-31	C162847	48780-1	9d75b9d1-1a7f-f424-e053-dadaa90a57ce	Senna and Docusate Sodium Film Coated Red Tablets 8.6 mg/ 50 mg Laxative
11534-134-60	2020-01-31	C162847	48780-1	9d75b9d1-1a7f-f424-e053-dadaa90a57ce	Senna and Docusate Sodium Film Coated Red Tablets 8.6 mg/ 50 mg Laxative

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11534-134-05	Senna and Docusate Sodium	57603 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	TABLET, FILM COATED	57603		5
11534-134-60	Senna and Docusate Sodium	60 in 1 BOTTLE	TABLET, FILM COATED	60		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
SENNOSIDES	ACTIVE INGREDIENT	3FYP5M0IJX	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
DOCUSATE	ACTIVE MOIETY	M7P27195AG	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
SENNOSIDES	ACTIVE MOIETY	3FYP5M0IJX	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11534-134	SENNA AND DOCUSATE SODIUM TABLET, FILM COATED [SUNRISE PHARMACEUTICAL INC]	5	Legacy NDC, 2 package rows	20130802_68d0fe5d-5de2-4853-bf8b-0042f14e8757.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F05Q2T2JA0	DOCUSATE SODIUM	577-11-7	DOCUSATE SODIUM
3FYP5M0IJX	SENNOSIDES		SENNOSIDES

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
998740	sennosides 8.6 MG / docusate sodium 50 MG Oral Tablet	PSN	68d0fe5d-5de2-4853-bf8b-0042f14e8757	5
998740	docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SCD	68d0fe5d-5de2-4853-bf8b-0042f14e8757	5
998740	DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SY	68d0fe5d-5de2-4853-bf8b-0042f14e8757	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
11534-134-05	11534013405	57603 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	Historical
11534-134-60	11534013460	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Senna and Docusate Sodium Film Coated Red Tablets 8.6 mg/ 50 mg Laxative	Sunrise Pharmaceutical Inc	2013-08-02	HUMAN OTC DRUG LABEL	5