SENNOSIDES AND DOCUSATE SODIUM

Product NDC: 49483-097
Requested package NDC: 49483-097-01
11-digit product format: 494830097
Labeler code: 49483
Product ID: 49483-097_2d9c974f-7555-3b50-e063-6294a90a406a
Type: HUMAN OTC DRUG
Nonproprietary name: SENNOSIDES AND DOCUSATE SODIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: TIME CAP LABORATORIES, INC
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-01-01
Substance: DOCUSATE SODIUM; SENNOSIDES
Active strength: 50; 8.6 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 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Additional Listing Data#

Finished product: Yes
Brand name base: SENNOSIDES AND DOCUSATE SODIUM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SENNOSIDES	50 mg/1
DOCUSATE SODIUM	8.6 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
0ad617e0-10a6-44fa-be62-4f3cc725fb01	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
49483-097-00	2025-02-10	209R TCL Laxative Docusate Sodium 50 mg Sennosides 8.6 mg Tablets
49483-097-01	2025-02-10	209R TCL Laxative Docusate Sodium 50 mg Sennosides 8.6 mg Tablets
49483-097-00	2025-01-30	209R TCL Laxative Docusate Sodium 50 mg Sennosides 8.6 mg Tablets
49483-097-01	2025-01-30	209R TCL Laxative Docusate Sodium 50 mg Sennosides 8.6 mg Tablets
49483-097-00	2021-11-29	209R TCL Laxative Docusate Sodium 50 mg Sennosides 8.6 mg Tablets
49483-097-01	2021-11-29	209R TCL Laxative Docusate Sodium 50 mg Sennosides 8.6 mg Tablets
49483-097-00	2020-01-31	209R TCL Laxative Docusate Sodium 50 mg Sennosides 8.6 mg Tablets
49483-097-01	2020-01-31	209R TCL Laxative Docusate Sodium 50 mg Sennosides 8.6 mg Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49483-097-00	SENNOSIDES AND DOCUSATE SODIUM	100000 in 1 CARTON	TABLET, FILM COATED	100000		3
49483-097-01	SENNOSIDES AND DOCUSATE SODIUM	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
SENNOSIDES	ACTIVE INGREDIENT	3FYP5M0IJX	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
DOCUSATE	ACTIVE MOIETY	M7P27195AG	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
SENNOSIDES	ACTIVE MOIETY	3FYP5M0IJX	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
STARCH, TAPIOCA	INACTIVE INGREDIENT	24SC3U704I	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	1
SENNOSIDES	ACTIVE INGREDIENT	3FYP5M0IJX	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	1
DOCUSATE	ACTIVE MOIETY	M7P27195AG	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	1
SENNOSIDES	ACTIVE MOIETY	3FYP5M0IJX	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-097	SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	3	Current NDC, Legacy NDC, 2 package rows	20250212_0ad617e0-10a6-44fa-be62-4f3cc725fb01.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 1 of 44 · 868 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topwin Speedy Enema	GLYCERIN	Health Chemical Pharmaceutical Co., Ltd	3ba8c3d2-1780-42e1-bec5-8f98771d475e	2026-07-27	Warnings	Exact identifier application number: M007
Curewell Senna Syrup	SENNOSIDES	RMT HEALTH LLC	57345324-5140-5cde-e063-6294a90ab97c	2026-07-22	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE ORAL SOLUTION	WALGREEN COMPANY	4ffe54ae-3126-ba58-e063-6294a90a8877	2026-07-20	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Bryant Ranch Prepack	deca083b-5c72-40fa-9021-b74028426a5a	2026-07-20	Warnings	Exact identifier application number: M007
Colace	DOCUSATE SODIUM	Atlantis Consumer Healthcare, Inc.	7793fced-e8ee-44e2-b212-dd2a59a5f462	2026-07-20	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Cardinal Health 107, LLC	fc5e82b6-e25c-4686-9781-2205819685f5	2026-07-20	Warnings	Exact identifier application number: M007
Best Choice Fiber Therapy Orange Flavor	PSYLLIUM HUSK	BEST CHOICE (VALU MERCHANDISERS COMPANY)	0b25f6c0-441b-41ef-ab19-2a29705a56c6	2026-07-17	Warnings	Exact identifier application number: M007
Best Choice Fiber Therapy original coarse	PSYLLIUM HUSK	BEST CHOICE (VALU MERCHANDISERS COMPANY)	d7eb71af-17e3-465e-b464-f77b3be7266d	2026-07-17	Warnings	Exact identifier application number: M007
Best Choice	CALCIUM POLYCARBOPHIL	BEST CHOICE (VALU MERCHANDISERS COMPANY)	24eb538f-abcb-4a91-b691-a8aac01c952a	2026-07-17	Warnings	Exact identifier application number: M007
Best Choice Fiber Laxative	PSYLLIUM HUSK	BEST CHOICE (VALU MERCHANDISERS COMPANY)	92b46689-b5fc-41f4-91ac-535699900b39	2026-07-17	Warnings	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	CVS Pharmacy, Inc.	498acb19-b2f4-4af0-8996-390115c17fe0	2026-07-17	Warnings, Adverse reactions	Exact identifier application number: M007
Best Choice Fiber Therapy	METHYLCELLULOSE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	fab6567f-d988-43f2-a6cf-44e5b24af279	2026-07-17	Warnings	Exact identifier application number: M007
stool softener	DOCUSATE SODIUM	Amazon.com Services LLC	4f83953e-3779-43b7-a5c6-7442a0675d9b	2026-07-16	Warnings	Exact identifier application number: M007
Stool Softener Extra Strength	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	183576bd-c252-471b-8797-32cac5b0329c	2026-07-16	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Walgreens	3f9d54d9-a9d5-40ff-a8a2-431997b58999	2026-07-16	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Walgreens	7174021b-bdc0-4fd3-90e7-3904980033c4	2026-07-16	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	STRATEGIC SOURCING SERVICES LLC	ff2179bd-cc76-9ee9-e053-6294a90a01c9	2026-07-15	Warnings	Exact identifier application number: M007
FEVIA Constipation Control	DOCUSATE SODIUM	VIVUNT PHARMA LLC	4b21ca11-b81f-402c-e063-6394a90a3acb	2026-07-15	Warnings	Exact identifier application number: M007
Docusate Sodium softgels 50mg (Dye Free)	DOCUSATE SODIUM	CVS Pharmacy	273ea95f-3c9c-98e8-e063-6294a90a2135	2026-07-14	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	STRATEGIC SOURCING SERVICES LLC	56957a51-7366-f7ed-e063-6294a90abfc5	2026-07-14	Warnings	Exact identifier application number: M007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F05Q2T2JA0	DOCUSATE SODIUM	577-11-7	DOCUSATE SODIUM
3FYP5M0IJX	SENNOSIDES		SENNOSIDES

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	0ad617e0-10a6-44fa-be62-4f3cc725fb01	3
998740	docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SCD	0ad617e0-10a6-44fa-be62-4f3cc725fb01	3
998740	DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SY	0ad617e0-10a6-44fa-be62-4f3cc725fb01	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49483-097-01	49483009701	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-097-01)	2010-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
209R TCL Laxative Docusate Sodium 50 mg Sennosides 8.6 mg Tablets	TIME CAP LABORATORIES, INC	2025-02-08	HUMAN OTC DRUG LABEL	3
DOK Plus Tablets	Major Pharmaceuticals	2019-08-27	HUMAN OTC DRUG LABEL	10