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 37 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Laxative Plus Stimulant	DOCUSATE SODIUM AND SENNOSIDES	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	dcab26ff-2c10-4478-90a8-c89d87261bfa	2024-03-19	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	4d1391da-7874-4a51-a468-2843ecf6f92b	2024-03-18	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	adaea845-e029-422d-a947-d8ce8f5787ed	2024-03-18	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	8b033d56-b95b-4905-9f33-cf2fbd61ce35	2024-03-15	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	CVS Pharmacy	6a97a181-1ec2-473d-a588-db2f2f2f662d	2024-03-14	Warnings	Exact identifier application number: M007
Stool Softener Extra Strength	DOCUSATE SODIUM	CVS Pharmacy	dcd27653-4c81-4630-a8b7-5fb5dc3e976a	2024-03-13	Warnings	Exact identifier application number: M007
EX-LAX REGULAR STRENGTH STIMULANT LAXATIVE	SENNOSIDES	Haleon US Holdings LLC	62544c2f-6e30-4cec-ae63-233715ef0699	2024-03-13	Warnings	Exact identifier application number: M007
Laxative Stool Softener	DOCUSATE SODIUM, SENNOSIDES	CVS Pharmacy	b52181e3-fd84-479e-8590-18619f6c0dae	2024-03-13	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	CVS Pharmacy	5eb047d2-8317-4de3-9268-d206ca039e3d	2024-03-13	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	CVS Pharmacy	f77c65b0-3e13-48ce-a2d9-36a9eba1851f	2024-03-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	CVS Pharmacy	849b057a-dc46-423c-a2f4-b01f135a3803	2024-03-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE CALCIUM	CVS Pharmacy	cf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cf	2024-03-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	CVS Pharmacy	8d59fa14-fc7c-4146-ba59-c2a907356dd6	2024-03-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Costco Wholesale	a19c20bd-84ff-4931-8312-2fbf0400e8e0	2024-03-06	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Care One (Retail Business Services, LLC.)	a1ea0993-2d23-44e3-bc72-e4bf497ab723	2024-03-05	Warnings	Exact identifier application number: M007
Senna Laxative	SENNOSIDES	Care One (Retail Business Services, LLC.)	a5994303-c9d0-4c6f-8eb7-5f364aa6ed0f	2024-03-05	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Care One (Retail Business Services, LLC.)	eb7f3d65-8741-407d-b3f3-1d9dda19684d	2024-03-05	Warnings	Exact identifier application number: M007
Fleet	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC	C.B. Fleet Company, Inc.	f50ba829-16c3-40a7-9822-8d6d00353b33	2024-02-29	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	BJWC (Berkley & Jensen / BJ's)	4ce62421-97e0-4920-9a6d-9fa1f0f93fe4	2024-02-23	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Bryant Ranch Prepack	851a5dda-e72b-4067-a98f-54d3222f646e	2024-02-23	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