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 34 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Senna-S	SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG	Proficient Rx LP	8678a3ee-0e2c-4c95-ad2e-83aa601f3238	2024-10-01	Warnings	Exact identifier application number: M007
Pedia-Lax	DOCUSATE SODIUM	C.B. Fleet Company, Inc.	0e908bea-ebab-44e7-919c-90002e6f5d42	2024-10-01	Warnings	Exact identifier application number: M007
Natural Vegetable Laxative and Stool Softener	DOCUSATE SODIUM AND SENNOSIDES	BETTER LIVING BRANDS LLC.	f2c562e1-4080-44cb-e053-2a95a90a4222	2024-09-25	Warnings	Exact identifier application number: M007
SENNA-S LAXATIVE WITH STOOL SOFTENER	SENNOSIDES	Basic Drugs, Inc.	d32b9956-fc04-8d64-e053-2a95a90a17b3	2024-09-14	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM, EXTRA STRENGTH 250 MG	DOCUSATE SODIUM	Advanced Rx LLC	e8be12c5-c591-eadd-e053-2a95a90a431b	2024-09-13	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	Proficient Rx LP	5f7f0df4-dabe-4c8f-a2b5-766f20af2f46	2024-09-01	Warnings	Exact identifier application number: M007
Fiber caplets 147	CALCIUM POLYCARBOPHIL	Chain Drug Marketing Association Inc.	17e2a50d-1867-49fe-e063-6394a90a56df	2024-08-27	Warnings	Exact identifier application number: M007
MAXIMUM STRENGTH LAXATIVE PILLS	SENNOSIDES	TARGET CORPORATION	7cae52ae-931c-3e7c-e053-2991aa0a8396	2024-08-22	Warnings	Exact identifier application number: M007
STOOL SOFTENER AND STIMULANT LAXATIVE	DOCUSATE SODIUM AND SENNOSIDES	TARGET CORPORATION	7cac99da-8d89-0aee-e053-2991aa0a0fd9	2024-08-22	Warnings	Exact identifier application number: M007
SENNA LAXATIVE	SENNOSIDES 8.6 MG	TARGET CORPORATION	7cab058f-3647-7124-e053-2a91aa0a41bd	2024-08-22	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Padagis Israel Pharmaceuticals Ltd	bce3b245-ec47-4e62-9cad-bb12d0812c18	2024-08-15	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	NuCare Pharmaceuticals,Inc.	56f7966a-c95e-3ce3-e054-00144ff88e88	2024-08-14	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Proficient Rx LP	ccfa095c-77f0-41ff-84f8-e02d983c7c74	2024-08-01	Warnings	Exact identifier application number: M007
Magnesium Citrate	HARRIS TEETER MAGNESIUM CITRATE ORAL SOLUTION - LEMON	Harris Teeter, LLC	1e8e01fc-2c89-9722-e063-6394a90a6acf	2024-07-31	Warnings	Exact identifier application number: M007
Senna laxative	SENNOSIDES	Best Choice (Valu Merchandisers Company)	d5f90aa1-78e5-491f-b09d-399d54f3def1	2024-07-31	Warnings	Exact identifier application number: M007
Stool Softener Laxative Plus Stimulant	DOCUSATE SODIUM AND SENNOSIDES	Walgreens	db528659-768a-46e0-a340-9fbcdb25ea5e	2024-07-25	Warnings	Exact identifier application number: M007
Senna laxative	SENNOSIDES	Walgreens	bfa089a6-4767-45e0-b663-ee7e8949d9a4	2024-07-25	Warnings	Exact identifier application number: M007
Dr. Fibra	PSYLLIUM HUSK	Pharmadel LLC	1a6151c9-e1c4-f0c1-e063-6394a90aad24	2024-07-22	Warnings	Exact identifier application number: M007
BISACODYL	BISCODYL	TARGET CORPORATION	8ed281d5-b17e-e3bb-e053-2995a90a2590	2024-07-15	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE CALCIUM	Walgreens	b6f0770e-671d-4965-9275-b1c224d7f06a	2024-07-10	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