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 22 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Senna Syrup	NATURAL VEGETABLE LAXATIVE	Method Pharmaceuticals	ce83ba78-7e0d-b37f-e053-2995a90a9383	2025-10-21	Warnings	Exact identifier application number: M007
Fiber Lax	CALCIUM POLYCARBOPHIL	PD-Rx Pharmaceuticals, Inc.	730198a5-b6d9-4fc7-b053-a7c65a93c540	2025-10-20	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Chain Drug Consortium LLC	4694f05b-d927-4e15-9630-a0a1cddb3cbb	2025-10-16	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Amerisource Bergen/Good Neighbor Pharmacy	e6a8914f-cfd9-4c72-abaa-22189bf0faef	2025-10-16	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Chain Drug Marketing Association Inc.	3386fada-6b7f-46fd-e063-6294a90abffc	2025-10-16	Warnings	Exact identifier application number: M007
Senna Syrup	SENNA SYRUP	Kesin Pharma Corporation	360fb98d-c6ad-7bcc-e063-6294a90a9453	2025-10-14	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	H E B	3d0566a1-57a5-6a31-e054-00144ff88e88	2025-10-09	Warnings	Exact identifier application number: M007
SENNA WITH DOCUSATE SODIUM	DOCUSATE SODIUM AND SENNOSIDES	HHH Pharmaceuticals	2bbb1b99-d43c-40a3-bc53-e18e8394c318	2025-10-08	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	BIONPHARMA INC.	3f9728e8-c7a2-6cfb-e063-6394a90a8f1d	2025-10-06	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	InvaTech Pharma Solutions LLC	3de39fbd-29be-fce7-e063-6394a90a67ae	2025-10-03	Warnings	Exact identifier application number: M007
Metamucil Therapy for regularity	PSYLLIUM HUSK	The Procter & Gamble Manufacturing Company	a9824f73-5ea2-4a65-a926-3a57561441b8	2025-10-01	Warnings	Exact identifier application number: M007
OneLAX SENNA	SENNA	Atlantic Biologicals Corp.	40202c76-4273-88fd-e063-6394a90a07b2	2025-10-01	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE ORAL SOLUTION	Bionpharma, Inc.	4019fbd0-fcf9-77a6-e063-6294a90a5ae7	2025-09-30	Warnings	Exact identifier application number: M007
LEADER HYDROCORTISONE WITH ALOE	HYDROCORTISONE	LEADER	39916470-15bf-4bd0-96e2-b909d68cf9c4	2025-09-29	Warnings	Exact identifier application number: M007
Leader Ready to Use Mineral Oil Laxative	MINERAL OIL	Cardinal Health	b8494d02-8a7d-47b4-80b0-b8ab51b625fd	2025-09-29	Warnings	Exact identifier application number: M007
Leader Ready to Use Saline Laxative	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Cardinal Health	1b4f9c28-0547-4922-aa15-990c6fd9dc9f	2025-09-29	Warnings	Exact identifier application number: M007
Milk of Magnesia	MAGNESIUM HYDROXIDE	Kesin Pharma Corporation	3f7cff50-749b-5275-e063-6394a90af407	2025-09-23	Warnings	Exact identifier application number: M007
Stimulant Laxative Plus Stool Softener	DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG	Bryant Ranch Prepack	12f613e4-c919-4cc4-a445-eb30039ae45f	2025-09-18	Warnings	Exact identifier application number: M007
Saline Laxative	SALINE LAXATIVE	Major Pharmaceuticals	b3758ffe-1bac-4df6-9714-5e33e9d28d90	2025-09-16	Warnings	Exact identifier application number: M007
Gentle Laxative	BISACODYL	BETTER LIVING BRANDS LLC.	f29d57f6-0938-d459-e053-2995a90ad86b	2025-09-13	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