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 38 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	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
Stool Softener Laxative	DOCUSATE SODIUM	BJWC (Berkley & Jensen / BJ's)	2ca80e23-f38a-4f77-b536-131cc9f0cf5b	2024-02-23	Warnings	Exact identifier application number: M007
Colon Detox	DOCUSATE SODIUM AND SENNOSIDES	OPMX LLC	0a4d3265-080c-d2ed-e063-6394a90adbee	2024-02-21	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM AND SENNOSIDES	Best Choice (Valu Merchandisers Company)	4501d718-15a7-4e27-bdb1-8aa2d3ff06d0	2024-02-20	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Best Choice (Valu Merchandisers Company)	72bd251b-4e82-41ef-8362-39f95faf9916	2024-02-15	Warnings	Exact identifier application number: M007
Magnesium Citrate	LEADER MAGNESIUM CITRATE ORAL SOLUTION - LEMON	CARDINAL HEALTH, INC. 063997360	10bdd5e6-3db2-8f9e-e063-6394a90a9b3f	2024-02-06	Warnings	Exact identifier application number: M007
Magnesium Citrate	LEADER MAGNESIUM CITRATE ORAL SOLUTION - GRAPE	CARDINAL HEALTH, INC. 063997360	10beb3ec-a189-221d-e063-6394a90aabb5	2024-02-06	Warnings	Exact identifier application number: M007
Magnesium Citrate	LEADER MAGNESIUM CITRATE ORAL SOLUTION - CHERRY	CARDINAL HEALTH, INC. 063997360	10bebb63-19b3-2e14-e063-6394a90a8d4e	2024-02-06	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Proficient Rx LP	f9ac0344-5864-4ac1-81bc-16878a5946c5	2024-02-01	Warnings	Exact identifier application number: M007
Purifi Hand Sanitizer	BENZALKONIUM CHLORIDE	Purifi LLC	9267069d-4cf5-4e48-a446-7dbebea16bf5	2024-01-31	Warnings	Exact identifier application number: M007
WOMENS LAXATIVE ENTERIC COATED	BISACODYL	CARDINAL HEALTH	ab34bc89-6738-d284-e053-2a95a90a5dc9	2024-01-11	Warnings	Exact identifier application number: M007
MAXIMUM STRENGTH LAXATIVE	SENNOSIDES	CARDINAL HEALTH	b7b13bfa-8a94-6f62-e053-2995a90abbf4	2024-01-10	Warnings	Exact identifier application number: M007
FIBER LAXATIVE	CALCIUM POLYCARBOPHIL	Magno-Humphries, Inc.	e4a921c5-1cf7-12ca-e053-2a95a90a6e04	2024-01-03	Warnings	Exact identifier application number: M007
Freskaro Castor Oil	CASTOR OIL	Pharma Nobis, LLC	fbd6bdd5-a7a1-3f28-e053-6294a90aab87	2023-12-28	Warnings	Exact identifier application number: M007
Humco Castor Oil	CASTOR OIL	Pharma Nobis, LLC	e42f9d37-1b07-177a-e053-2a95a90a9b06	2023-12-26	Warnings	Exact identifier application number: M007
Magnesium Citrate	FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMON	Pharma Nobis, LLC	f0477328-eca1-9043-e053-2995a90aaa3d	2023-12-22	Warnings	Exact identifier application number: M007
Magnesium Citrate	FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRY	Pharma Nobis, LLC	f0489f6f-9e60-7d69-e053-2a95a90a9dfb	2023-12-22	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