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 37 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Laxative	DOCUSATE SODIUM	TARGET Corporation	89106733-69f1-469b-9d07-f06ac09b2fb6	2024-04-02	Warnings	Exact identifier application number: M007
FLEET	MINERAL OIL	C.B. Fleet Company, Inc.	e0b7acab-add4-4daf-b1df-bb7cf5ca8e19	2024-04-01	Warnings	Exact identifier application number: M007
Stool Softener Laxative Plus Stimulant	DOCUSATE SODIUM AND SENNOSIDES	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	89dc2063-6744-4412-89be-90990090b57c	2024-03-19	Warnings	Exact identifier application number: M007
Senna Laxative	SENNOSIDES	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	2322765d-6f08-48d4-a500-818a8a558f6f	2024-03-19	Warnings	Exact identifier application number: M007
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

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