Senna-S

Product NDC: 16103-378
11-digit product format: 161030378
Labeler code: 16103
Product ID: 16103-378_0783ba51-f52a-4ac9-a5fe-ae0bfb6ef57c
Type: HUMAN OTC DRUG
Nonproprietary name: Sennosides 8.6mg and Docusate Sodium 50mg
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Pharbest Pharmaceuticals, Inc.
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-11-05
Substance: SENNOSIDES; DOCUSATE SODIUM
Active strength: 8.6; 50 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
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	16103-378-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16103-378-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16103-378-07	`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	16103-378-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16103-378-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16103-378-07	`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	16103-378-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16103-378-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16103-378-07	`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	16103-378-08	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16103-378-11	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16103-378-07	`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	16103-378-08	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16103-378-11	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16103-378-07	`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	16103-378-08	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16103-378-11	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16103-378-07	`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	16103-378-08	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	16103-378-11	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	16103-378-07	`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	16103-378-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	16103-378-11	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	16103-378-07	`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	16103-378-08	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	16103-378-11	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	16103-378-07	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Senna-S
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SENNOSIDES	8.6 mg/1
DOCUSATE SODIUM	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3FYP5M0IJX	Internal UNII lookup
F05Q2T2JA0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998740	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2b5152b2-d354-409f-a19f-b470f4181b3f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
16103-378-07	2024-12-31	Drug Facts
16103-378-08	2024-12-31	Drug Facts
16103-378-11	2024-12-31	Drug Facts
16103-378-07	2022-01-28	Drug Facts
16103-378-08	2022-01-28	Drug Facts
16103-378-11	2022-01-28	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16103-378-07	Senna-S	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	3
16103-378-08	Senna-S	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	3
16103-378-11	Senna-S	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16103-378-11	EA - Each	16103-378	011d0b12-3043-4597-a0fa-fbe72c961b7d	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16103-378	SENNA-S (SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 3 package rows	20250101_2b5152b2-d354-409f-a19f-b470f4181b3f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 13 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Epsom Salt	MAGNESIUM SULFATE	Sam's West, Inc	6edb7688-0a64-4a7e-a0c0-9f75c96682fe	2026-02-03	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	cb2698b1-6c58-417f-ae86-74fbe3814626	2026-02-03	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	CVS Pharmacy, Inc.	f20de8f2-3637-4485-8b80-0a12fd5e651c	2026-02-02	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	CVS Pharmacy, Inc.	1dca8f4a-f544-4ae5-bb0a-8b671d4a488a	2026-02-02	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	CVS Pharmacy, Inc.	15a9996d-7391-41f8-ab15-27ee2a6a60e4	2026-02-02	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Rite Aid Corporation	e562bf42-b9e1-4ea8-b880-7bec4dd620b4	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M007
SENNA-S	DOCUSATE SODIUM AND SENNOSIDES	Strategic Sourcing Services, LLC	905bd658-a0af-4f20-be3d-00c54868a26c	2026-01-29	Warnings	Exact identifier application number: M007
Senna Laxative	SENNOSIDES	Strategic Sourcing Services LLC	9248a907-a8bd-47d5-98a2-48534d6023d4	2026-01-29	Warnings	Exact identifier application number: M007
Leader Castor Oil	CASTOR OIL	Cardinal Health, 110 dba Leader	49e3a40a-b717-43f6-abed-473d7ed03c2e	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	CARDINAL HEALTH 110, LLC. DBA LEADER	803f444f-d136-4f06-9842-24a71a3d7d6b	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M007
Equate Ready-to-Use Enema Laxative	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	WalMart	04c7440e-5b25-4b63-9604-321298d51021	2026-01-29	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Meijer Distribution Inc.	81edf0d8-b6f3-4b3a-85db-0108160756b1	2026-01-28	Warnings	Exact identifier application number: M007
Quality Choice Laxative	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Chain Drug Marketing Association	1cac3b6b-155b-47bb-bb79-17c55d345736	2026-01-28	Warnings	Exact identifier application number: M007
Docusate Sodium and Sennosides	DOCUSATE SODIUM AND SENNOSIDES	SOFTGEL HEALTHCARE PRIVATE LIMITED	1ad73079-ebb3-dae7-e063-6294a90a0558	2026-01-28	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM 100MG	DOCUSATE SODIUM 100MG	Farmacias De Similares TX LLC	44269b79-a5ad-f443-e063-6294a90a8473	2026-01-28	Warnings	Exact identifier application number: M007
Docusate Sodium and Sennosides	DOCUSATE SODIUM AND SENNOSIDES	SOFTGEL HEALTHCARE PRIVATE LIMITED	19830f9a-27b1-910d-e063-6294a90adace	2026-01-27	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	SOFTGEL HEALTHCARE PRIVATE LIMITED	94936bd4-8bbf-6211-e053-2995a90a2138	2026-01-27		Exact identifier application number: M007
Sennosides	SENNOSIDES	Softgel Healthcare Pvt Ltd	16582306-7321-6c7c-e063-6394a90a509e	2026-01-27	Warnings	Exact identifier application number: M007
Vegetable Laxative	SENNOSIDES	Wal-Mart Stores Inc	97695092-1ded-4723-a015-fdadd7c28c81	2026-01-27	Warnings	Exact identifier application number: M007
Calcium Polycarbophil	CALCIUM POLYCARBOPHIL	CVS Pharmacy, Inc	c3de1c1b-5042-aec3-e053-2a95a90ad134	2026-01-27	Warnings	Exact identifier application number: M007

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

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	2b5152b2-d354-409f-a19f-b470f4181b3f	3
998740	docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SCD	2b5152b2-d354-409f-a19f-b470f4181b3f	3
998740	DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SY	2b5152b2-d354-409f-a19f-b470f4181b3f	3
998740	sennosides 8.6 MG / docusate sodium 50 MG Oral Tablet	PSN	8678a3ee-0e2c-4c95-ad2e-83aa601f3238	2
998740	docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SCD	8678a3ee-0e2c-4c95-ad2e-83aa601f3238	2
998740	DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SY	8678a3ee-0e2c-4c95-ad2e-83aa601f3238	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16103-378-07	16103037807	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16103-378-07)	2018-11-05	0000-00-00	No	No	Current
16103-378-08	16103037808	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16103-378-08)	2019-02-21	0000-00-00	No	No	Current
16103-378-11	16103037811	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16103-378-11)	2018-11-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Pharbest Pharmaceuticals, Inc.	2025-12-24	HUMAN OTC DRUG LABEL	3
Drug Facts	Proficient Rx LP	2024-10-01	HUMAN OTC DRUG LABEL	2
Drug Facts	PD-Rx Pharmaceuticals, Inc.	2023-10-03	HUMAN OTC DRUG LABEL	7
DOCUSATE SODIUM AND SENNA	DIRECTRX	2019-04-09	HUMAN OTC DRUG LABEL	1