Senna Tabs

Product NDC: 16103-363
11-digit product format: 161030363
Labeler code: 16103
Product ID: 16103-363_61f99f78-d945-4004-a167-f3a80979f4a4
Type: HUMAN OTC DRUG
Nonproprietary name: Senna
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Pharbest Pharmaceuticals, Inc.
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-09-03
Substance: SENNOSIDES A AND B
Active strength: 8.6 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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16103-363-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16103-363-11	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16103-363-08	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16103-363-11	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16103-363-08	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16103-363-11	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16103-363-08	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16103-363-11	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16103-363-08	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16103-363-11	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16103-363-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16103-363-11	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	16103-363-08	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	16103-363-11	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	16103-363-08	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	16103-363-11	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	16103-363-08	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	16103-363-11	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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 Tabs
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SENNOSIDES A AND B	8.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1B5FPI42EN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312935	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
b9f8ea59-932f-4827-a87c-b4aff909c43f	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
16103-363-08	2024-12-31	Drug Facts
16103-363-11	2024-12-31	Drug Facts
16103-363-08	2023-01-30	Drug Facts
16103-363-11	2023-01-30	Drug Facts
16103-363-08	2021-03-27	Drug Facts
16103-363-11	2021-03-27	Drug Facts
16103-363-08	2020-01-31	Drug Facts
16103-363-11	2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16103-363-08	Senna Tabs	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		4
16103-363-11	Senna Tabs	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16103-363-08	EA - Each	16103-363	d1c46bcd-5c41-4cf5-a0d1-def0b83c46da	1	2012-07-24
16103-363-11	EA - Each	16103-363	52f694b3-25f1-401c-a42d-b8750a77e2a6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SENNOSIDES A AND B	ACTIVE INGREDIENT	1B5FPI42EN	SENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]	1
SENNOSIDES A AND B	ACTIVE MOIETY	1B5FPI42EN	SENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	SENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	SENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16103-363	SENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20250101_b9f8ea59-932f-4827-a87c-b4aff909c43f.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 23 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	H E B	ab995d9a-1e40-2b38-e053-2a95a90a87e4	2025-08-21	Warnings	Exact identifier application number: M007
Senokot	STANDARDIZED SENNA CONCENTRATE	Atlantis Consumer Healthcare, Inc.	d5bf67e5-82c6-edbf-e9ec-e027fdd47c84	2025-08-20	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	BJWC (Berkley & Jensen / BJ's)	330758d2-fc1a-50ce-e063-6294a90a7db1	2025-08-19	Warnings	Exact identifier application number: M007
Sennosides and Docusate Sodium	SENNOSIDES AND DOCUSATE SODIUM	American Health Packaging	4b84d5d7-43cf-47bb-af59-088550c3a0bc	2025-08-12	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Good Sense (Geiss, Destin & Dunn, Inc.)	8066a52d-e683-47c1-905c-290d2d427acf	2025-08-12	Warnings	Exact identifier application number: M007
Prolaxa	DOCUSATE SODIUM 250MG	Advanced Rx of Tennessee, LLC	3ba0c0d9-9e6f-a2e6-e063-6394a90a202d	2025-08-05	Warnings	Exact identifier application number: M007
Dulcolax Stool Softener	DOCUSATE SODIUM	Chattem, Inc.	86cb7102-3585-4757-9c37-5bf9776bbe63	2025-08-01	Warnings	Exact identifier application number: M007
LEADER Mineral Oil	MINERAL OIL	Cardinal Health, 110 dba Leader	7d4f8fa3-8203-5523-e053-2991aa0aba1a	2025-07-28	Warnings	Exact identifier application number: M007
Rapidol Sal Inglesa	MAGNESIUM SULFATE HEPTAHYDRATE	Pharmadel LLC	1d4ef5f0-54c5-4838-e063-6394a90a44a8	2025-07-28	Warnings	Exact identifier application number: M007
Enemeez Kids	DOCUSATE SODIUM	Quest Products LLC	f1602ba4-ad02-2936-e053-2995a90a27f2	2025-07-15	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	Bryant Ranch Prepack	d4ab04e4-b78a-4afc-aa16-d9dc8fb6cc10	2025-07-14	Warnings	Exact identifier application number: M007
Epsom Salt	EPSOM SALT	Strategic Sourcing Services LLC	1515fadd-a7a5-4502-afe2-cfcd50d5bfc8	2025-07-11	Warnings	Exact identifier application number: M007
Quality Choice Fiber Caplets	CALCIUM POLYCARBOPHIL	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	29dbc831-23c1-487d-902a-9404d9ebe805	2025-07-09	Warnings	Exact identifier application number: M007
Rexall Ready to use 4pk LAXATIVE	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Dolgencorp, LLC	78509915-0ef1-4238-99a5-78a49a68f98f	2025-07-07	Warnings	Exact identifier application number: M007
Sal Inglesa EPSOM SALT	MAGNESIUM SULFATE HEPTAHYDRATE	Menper Distributors, Inc	247aa3a3-d38f-4799-b44d-dfe18324fd0c	2025-07-01	Warnings	Exact identifier application number: M007
Stool Softener Extra Strength	DOCUSATE SODIUM	Chain Drug Consortium, LLC	550000ba-0d6d-4666-8461-f591c14478b1	2025-06-27	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Chain Drug Consortium, LLC	c9807e6e-9dcc-41a2-8956-b61623ac2176	2025-06-27	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Chain Drug Consortium, LLC	09449649-fd57-4446-8264-6c3bdd6621d0	2025-06-27	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	Bryant Ranch Prepack	f2b14378-2b60-4533-b232-8c8647fbce78	2025-06-26	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	TARGET CORPORATION	28fce2e2-2101-df88-e063-6394a90aa3de	2025-06-25	Warnings	Exact identifier application number: M007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1B5FPI42EN	SENNOSIDES A AND B	62211-03-4	SENNOSIDES A AND B

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312935	sennosides 8.6 MG Oral Tablet	PSN	2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa	9
312935	sennosides, USP 8.6 MG Oral Tablet	SCD	2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa	9
312935	sennosides A and B 8.6 MG Oral Tablet	SY	2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa	9
312935	sennosides 8.6 MG Oral Tablet	PSN	b9f8ea59-932f-4827-a87c-b4aff909c43f	4
312935	sennosides, USP 8.6 MG Oral Tablet	SCD	b9f8ea59-932f-4827-a87c-b4aff909c43f	4
312935	sennosides A and B 8.6 MG Oral Tablet	SY	b9f8ea59-932f-4827-a87c-b4aff909c43f	4
312935	sennosides 8.6 MG Oral Tablet	PSN	cd6e3fb4-0c5a-4aa7-89ea-109c6d072efe	3
312935	sennosides, USP 8.6 MG Oral Tablet	SCD	cd6e3fb4-0c5a-4aa7-89ea-109c6d072efe	3
312935	sennosides A and B 8.6 MG Oral Tablet	SY	cd6e3fb4-0c5a-4aa7-89ea-109c6d072efe	3
312935	sennosides 8.6 MG Oral Tablet	PSN	bcf5bc3f-60c8-bfd7-e053-2a95a90a97a7	1
312935	sennosides, USP 8.6 MG Oral Tablet	SCD	bcf5bc3f-60c8-bfd7-e053-2a95a90a97a7	1
312935	sennosides A and B 8.6 MG Oral Tablet	SY	bcf5bc3f-60c8-bfd7-e053-2a95a90a97a7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16103-363-08	16103036308	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16103-363-08)	2018-09-03	0000-00-00	No	No	Current
16103-363-11	16103036311	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16103-363-11)	2018-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Pharbest Pharmaceuticals, Inc. \| Pharbest Pharmaceuticals, Inc	2025-12-24	HUMAN OTC DRUG LABEL	4
Drug Facts	PD-Rx Pharmaceuticals, Inc.	2025-05-21	HUMAN OTC DRUG LABEL	9
Drug Facts	ATLANTIC BIOLOGICALS CORP. \| UNIT DOSE SOLUTIONS	2024-05-09	HUMAN OTC DRUG LABEL	3
Drug Facts	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2021-03-07	HUMAN OTC DRUG LABEL	1