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 40 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Milk of Magnesia mint	MAGNESIUM HYDROXIDE	Meijer, Inc.	bb8ba371-f53c-1088-e053-2a95a90a4cbf	2023-11-08	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	STRATEGIC SOURCING SERVICES LLC	00c61622-367b-0a5b-e063-6294a90a6706	2023-11-08	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Strategic Sourcing Services LLC	003a3c0d-7a48-e44d-e063-6394a90a3f4a	2023-11-08	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA MINT	MAGNESIUM HYDROXIDE	Geri-Care Pharmaceuticals, Corp	2d1be236-e136-4727-a52d-714f62880088	2023-11-08	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	AMERISOURCEBERGEN DRUG CORPORATION	5d690d82-e4fb-57ad-e053-2a91aa0a38ea	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA MINT	MAGNESIUM HYDROXIDE	AMERISOURCEBERGEN DRUG CORPORATION	5d6a8048-93e7-42e5-e053-2991aa0acabd	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA CHERRY	MAGNESIUM HYDROXIDE	AMERISOURCEBERGEN DRUG CORPORATION	5d7f5a38-4222-5bfb-e053-2991aa0a17e3	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA MINT	MAGNESIUM HYDROXIDE	CARDINAL HEALTH	af4b6b64-97c9-a794-e053-2a95a90aaf0b	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	CARDINAL HEALTH	af5ddf5d-b1f5-2918-e053-2995a90a2d61	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA MINT	MAGNESIUM HYDROXIDE	H E B	ab998776-6b30-9f17-e053-2995a90a96cd	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	H E B	abfe89c8-86f1-bd1e-e053-2995a90af773	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	GOODSENSE	a951617d-c6fa-75e0-e053-2995a90afcf8	2023-11-07	Warnings	Exact identifier application number: M007
Milk of Magnesia	MAGNESIUM HYDROXIDE	KROGER COMPANY	a1b04366-ff67-3bb3-e053-2a95a90a816c	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	BETTER LIVING BRANDS, LLC	b9440381-df40-4bc7-e053-2995a90ae83f	2023-11-07	Warnings	Exact identifier application number: M007
Milk of Magnesia mint	MAGNESIUM HYDROXIDE	TOP CARE (TOPCO ASSOCIATES LLC)	b83f6027-51a0-1730-e053-2995a90a553b	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	TOP CARE (TOPCO ASSOCIATES LLC)	b83eb807-d522-4408-e053-2a95a90a7926	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA CHERRY	MAGNESIUM HYDROXIDE	TOP CARE (TOPCO ASSOCIATES LLC)	b83f0c1c-0e90-2888-e053-2995a90a0b96	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	DOLGENCORP, INC.	b6991abf-9819-701c-e053-2a95a90ac0b4	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA MINT	MAGNESIUM HYDROXIDE	Chain Drug Marketing Association	7722145c-913c-4ed5-a9b2-a6c343064066	2023-11-06	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA CHERRY	MAGNESIUM HYDROXIDE	Chain Drug Marketing Association	12361478-d178-4950-9458-4e2e56565599	2023-11-06	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