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 32 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NuValu Epsom Salt	MAGNESIUM SULFATE (HEPTAHYDRATE)	J C SALES	5a503d8d-7899-4b1e-be6f-8e2a759af265	2024-12-04	Warnings	Exact identifier application number: M007
SENNOSIDES	SENNOSIDES	CVS Pharmacy, Inc.	6dffc3f5-bae0-c436-e053-2991aa0a0f8b	2024-12-02	Warnings	Exact identifier application number: M007
Pure and Gentle	MINERAL OIL	Medline Industries, LP	96d4cad5-0602-4c31-94ed-3117b4fd4a94	2024-11-26	Warnings	Exact identifier application number: M007
Pure and Gentle Laxative	SODIUM PHOSPHATE	Medline Industries, LP	e3165538-75dd-4f0f-adc8-d4075de10f1e	2024-11-26	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM 50 MG	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	af7533e6-8b06-48a4-940e-7ecb57b24b59	2024-11-25	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM 100mg Two-Tone	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	a923e5ca-86fd-4bf9-9931-180ddfdeae66	2024-11-25	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM 100mg Two-Tone	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	7cf1df18-d658-4bff-8a62-365fc5656942	2024-11-25	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM 100mg	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	c5bdfbfc-d24a-4088-9b60-ecea8120ff43	2024-11-25	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	b10fdf50-289e-41f3-9b83-a4e4dd892f88	2024-11-21	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM 100mg Two-Tone	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	85c64624-428d-46fa-8071-f42b8feec049	2024-11-21	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd	33251cb7-b7b1-4f6c-9e10-4fa64cbf03a0	2024-11-21	Warnings	Exact identifier application number: M007
STOOL SOFTENER	DOCUSATE SODIUM	Walgreen Co.	d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab5	2024-11-21	Warnings	Exact identifier application number: M007
4718 Enema, Mineral Oil	4718 ENEMA, MINERAL OIL	Dynarex	9e51c852-9477-5cf5-e053-2a95a90a97db	2024-11-20	Warnings	Exact identifier application number: M007
Relief	SODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	Leosons Overseas Corp	5b301d5b-1e2c-47ed-a05f-d6be0fdfc940	2024-11-19	Warnings	Exact identifier application number: M007
REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Leosons Overseas Corp	90e7c2b4-35e1-4a27-afea-9257c480e190	2024-11-19	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM 100MG	PuraCap Pharmaceutical LLC	272c86f1-f229-2ebf-e063-6394a90a3471	2024-11-18	Warnings	Exact identifier application number: M007
Milk of Magnesia Concentrate	MAGNESIUM HYDROXIDE	PAI Holdings, LLC dba PAI Pharma	2a99a1a8-a830-429f-9cfd-3f29c3d3547c	2024-11-12	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	A-S Medication Solutions	122486e9-74dd-4181-97d1-0b07688280f4	2024-11-06	Warnings	Exact identifier application number: M007
Stratuscare Adult Glycerin	GLYCERIN	Stratus Pharmaceuticals	3e1935da-5c1f-4942-98dd-320fade82321	2024-11-04	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM	DOCUSATE SODIUM	NuCare Pharmaceuticals,Inc.	fdf3c8e1-d554-4cdb-e053-6394a90a542e	2024-11-01	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