SIMPEX Bisacodyl laxative

Product NDC: 76457-003
11-digit product format: 764570003
Labeler code: 76457
Product ID: 76457-003_0b586450-2c14-70e7-e063-6394a90a5f33
Type: HUMAN OTC DRUG
Nonproprietary name: BISACODYL
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Simpex Pharma Pvt. Ltd
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-02-09
Substance: BISACODYL
Active strength: 5 mg/1
Pharmacologic classes: Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: SIMPEX Bisacodyl laxative
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BISACODYL	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
10X0709Y6I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308753	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
5114ed64-4fec-401b-8a91-8df3e42b10b1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76457-003-00	SIMPEX Bisacodyl laxative	100 in 1 CARTON	TABLET, COATED	100		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISACODYL	ACTIVE INGREDIENT	10X0709Y6I	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
BISACODYL	ACTIVE MOIETY	10X0709Y6I	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76457-003	SIMPEX BISACODYL LAXATIVE (BISACODYL) TABLET, COATED [SIMPEX PHARMA PVT. LTD]	7	Current NDC, Legacy NDC, 1 package rows	20231201_5114ed64-4fec-401b-8a91-8df3e42b10b1.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 35 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener	DOCUSATE SODIUM	Bryant Ranch Prepack	2c9a1fe7-b77b-436b-8701-9f95f642d001	2024-07-05	Warnings	Exact identifier application number: M007
SENNA	SENNA	Precision Dose, Inc.	e637777e-a39d-4e2f-a95c-4f524aa122f7	2024-07-05	Warnings	Exact identifier application number: M007
Gentle Laxative	MAGNESIUM HYDROXIDE	GERI-CARE PHARMACEUTICALS, CORP	1c462af8-af1a-391c-e063-6394a90a8b49	2024-07-02	Warnings	Exact identifier application number: M007
Good Neighbor Pharmacy Fiber-Caps Fiber Laxative Stimulant Free	CALCIUM POLYCARBOPHIL	Amerisourcebergen Drug Corporation	4911fb44-e070-46c1-8f90-b78ceb10e51e	2024-06-28	Warnings	Exact identifier application number: M007
Fleet	DOCUSATE SODIUM	C.B. Fleet Company, Inc.	56a7b6c5-d674-4eed-91c2-77f7d18fff32	2024-06-27	Warnings	Exact identifier application number: M007
Stool Softener Laxative Extra Strength	DOCUSATE SODIUM	WALMART INC. (see also Equate)	2cf6c9bf-c318-445d-9306-5675b1d424b0	2024-06-26	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	WALMART INC. (see also Equate)	d9db24b5-e3b5-47f9-b86b-bc8d70896a11	2024-06-26	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE CALCIUM	Walgreens	2791223a-7ac0-47e5-9a6a-4d9a02cfeb63	2024-06-25	Warnings	Exact identifier application number: M007
Fleet	BISACODYL	C.B. Fleet Company, Inc.	4e0d973f-e6dc-48d9-8df3-1d47c87840f1	2024-06-21	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	TOP CARE (Topco Associates LLC)	3b184800-649b-45d0-9586-8055d6d7fe08	2024-06-20	Warnings	Exact identifier application number: M007
Senna Laxative	SENNA LAXATIVE	Good Sense	9393032e-4343-4ac5-8e91-36013e5ca089	2024-06-18	Warnings	Exact identifier application number: M007
Stool Softener	STOOL SOFTENER	Good Sense	64266195-1b07-42c2-98a7-d76c12f74776	2024-06-18	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant	DOCUSATE SODIUM AND SENNOSIDES	United Natural Foods, Inc. dba UNFI	6c8c7c46-3ded-4e89-8e16-30eeb72aa08b	2024-06-14	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	United Natural Foods, Inc. dba UNFI	50ca1ce2-885f-4b71-a5fb-90c2cf508ce6	2024-06-14	Warnings	Exact identifier application number: M007
basic care stool softener	DOCUSATE SODIUM	Amazon.com Services LLC	356a889f-ec23-4eb2-a25c-bbe609475155	2024-06-14	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	United Natural Foods, Inc. dba UNFI	88cc2575-27a1-4514-bc41-bd1eac283814	2024-06-13	Warnings	Exact identifier application number: M007
Senna laxative	SENNOSIDES	United Natural Foods, Inc. dba UNFI	2b5e1f03-0182-4d1c-8ba0-b1008b1335ad	2024-06-12	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	TARGET Corporation	1b7edd67-7b14-4fdd-9821-637f4b3c3a2c	2024-06-06	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	Patrin Pharma, Inc.	a9f1ef8d-8700-481f-a709-972bb9d27153	2024-05-30	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	WALGREEN COMPANY	5f9cd233-6c46-5b52-e053-2991aa0ab729	2024-05-23	Warnings	Exact identifier application number: M007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
10X0709Y6I	BISACODYL	603-50-9	BISACODYL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308753	bisacodyl 5 MG Delayed Release Oral Tablet	PSN	5114ed64-4fec-401b-8a91-8df3e42b10b1	7
308753	bisacodyl 5 MG Delayed Release Oral Tablet	SCD	5114ed64-4fec-401b-8a91-8df3e42b10b1	7
308753	bisacodyl 5 MG Enteric Coated Oral Tablet	SY	5114ed64-4fec-401b-8a91-8df3e42b10b1	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
76457-003-00	76457000300	100 TABLET, COATED in 1 CARTON (76457-003-00)	2018-02-09	0000-00-00	No	No	Current