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 22 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Senna Syrup	NATURAL VEGETABLE LAXATIVE	Method Pharmaceuticals	ce83ba78-7e0d-b37f-e053-2995a90a9383	2025-10-21	Warnings	Exact identifier application number: M007
Fiber Lax	CALCIUM POLYCARBOPHIL	PD-Rx Pharmaceuticals, Inc.	730198a5-b6d9-4fc7-b053-a7c65a93c540	2025-10-20	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Chain Drug Consortium LLC	4694f05b-d927-4e15-9630-a0a1cddb3cbb	2025-10-16	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Amerisource Bergen/Good Neighbor Pharmacy	e6a8914f-cfd9-4c72-abaa-22189bf0faef	2025-10-16	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Chain Drug Marketing Association Inc.	3386fada-6b7f-46fd-e063-6294a90abffc	2025-10-16	Warnings	Exact identifier application number: M007
Senna Syrup	SENNA SYRUP	Kesin Pharma Corporation	360fb98d-c6ad-7bcc-e063-6294a90a9453	2025-10-14	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	H E B	3d0566a1-57a5-6a31-e054-00144ff88e88	2025-10-09	Warnings	Exact identifier application number: M007
SENNA WITH DOCUSATE SODIUM	DOCUSATE SODIUM AND SENNOSIDES	HHH Pharmaceuticals	2bbb1b99-d43c-40a3-bc53-e18e8394c318	2025-10-08	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	BIONPHARMA INC.	3f9728e8-c7a2-6cfb-e063-6394a90a8f1d	2025-10-06	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	InvaTech Pharma Solutions LLC	3de39fbd-29be-fce7-e063-6394a90a67ae	2025-10-03	Warnings	Exact identifier application number: M007
Metamucil Therapy for regularity	PSYLLIUM HUSK	The Procter & Gamble Manufacturing Company	a9824f73-5ea2-4a65-a926-3a57561441b8	2025-10-01	Warnings	Exact identifier application number: M007
OneLAX SENNA	SENNA	Atlantic Biologicals Corp.	40202c76-4273-88fd-e063-6394a90a07b2	2025-10-01	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE ORAL SOLUTION	Bionpharma, Inc.	4019fbd0-fcf9-77a6-e063-6294a90a5ae7	2025-09-30	Warnings	Exact identifier application number: M007
LEADER HYDROCORTISONE WITH ALOE	HYDROCORTISONE	LEADER	39916470-15bf-4bd0-96e2-b909d68cf9c4	2025-09-29	Warnings	Exact identifier application number: M007
Leader Ready to Use Mineral Oil Laxative	MINERAL OIL	Cardinal Health	b8494d02-8a7d-47b4-80b0-b8ab51b625fd	2025-09-29	Warnings	Exact identifier application number: M007
Leader Ready to Use Saline Laxative	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Cardinal Health	1b4f9c28-0547-4922-aa15-990c6fd9dc9f	2025-09-29	Warnings	Exact identifier application number: M007
Milk of Magnesia	MAGNESIUM HYDROXIDE	Kesin Pharma Corporation	3f7cff50-749b-5275-e063-6394a90af407	2025-09-23	Warnings	Exact identifier application number: M007
Stimulant Laxative Plus Stool Softener	DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG	Bryant Ranch Prepack	12f613e4-c919-4cc4-a445-eb30039ae45f	2025-09-18	Warnings	Exact identifier application number: M007
Saline Laxative	SALINE LAXATIVE	Major Pharmaceuticals	b3758ffe-1bac-4df6-9714-5e33e9d28d90	2025-09-16	Warnings	Exact identifier application number: M007
Gentle Laxative	BISACODYL	BETTER LIVING BRANDS LLC.	f29d57f6-0938-d459-e053-2995a90ad86b	2025-09-13	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