Home NDC 76457-003 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.
DailyMed Product Concepts# 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 Uploaded 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 29 of 42 · 833 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Chocolated Laxative SENNOSIDES STIMULANT LAXATIVE Walgreens c8ea170b-57b5-4643-ba88-4cf2ae1bf6a0 2024-12-23 Warnings Exact identifier application number: M007 Sennosides SENNOSIDES Meijer, Inc. b09a234e-962d-49fc-a72e-898547b2f099 2024-12-23 Warnings Exact identifier application number: M007 Pedia-Lax GLYCERIN C.B. Fleet Company, Inc. 4e15f6ca-a40c-485f-be3f-07c2ed7cb498 2024-12-23 Warnings Exact identifier application number: M007 Chocolate Laxative Regular strength, Sennosides Stimulant Laxative, equate SENNOSIDES Wal-Mart Stores Inc 10dc8b4d-8136-44a5-a2ce-30295866cd3b 2024-12-23 Warnings Exact identifier application number: M007 Chocolated Laxative Regular Strength Sennosides Stimulant Laxative, Best Choice SENNOSIDES Valu Merchandisers Company 4b7cab4b-a610-4fb9-ac31-011975f1b29c 2024-12-23 Warnings Exact identifier application number: M007 Chocolated Laxative Regular Strength Sennosides Stimulant Laxative, DG health SENNOSIDES Dolgencorp Inc. 88dc2f9b-18ca-4e21-8faa-5339f82a2a75 2024-12-23 Warnings Exact identifier application number: M007 Chocolated Laxative Regular Strength Sennosides Stimulant Laxative TopCare health SENNOSIDES Topco Associates f051b302-f70e-4ab6-bb69-f69b45f2642e 2024-12-23 Warnings Exact identifier application number: M007 Chocolated Laxative SENNOSIDES STIMULANT LAXATIVE C.D.M.A., Inc. e80be2b6-a0ca-4838-b956-a1debb065d57 2024-12-23 Warnings Exact identifier application number: M007 Conlax BISACODYL Bliss GVS Pharma Limited 7d25990b-6f7c-1eac-e053-2a91aa0a7022 2024-12-21 Warnings Exact identifier application number: M007 GeriCare Docusate Sodium Liquid DOCUSATE SODIUM GERI-CARE PHARMACEUTICALS, CORP e50558e1-f0c8-4b03-9109-6a273b61730d 2024-12-20 Warnings Exact identifier application number: M007 SENNA Syrup SENNOSIDES A AND B SDA Laboratories, Inc. cfc6ab2f-5376-46fc-ac58-7dedd7010006 2024-12-20 Warnings Exact identifier application number: M007 Fiber Therapy CALCIUM POLYCARBOPHIL Wal-Mart Stores, Inc. 3432a4a6-aeb1-4a72-8451-5903266931fa 2024-12-20 Warnings Exact identifier application number: M007 Fiber Laxative CALCIUM POLYCARBOPHIL UNITED NATURAL FOODS, INC. DBA UNFI f7236bbc-8ded-4e11-8cce-b0a2255e1450 2024-12-20 Warnings Exact identifier application number: M007 Fiber Caps CALCIUM POLYCARBOPHIL Guardian Drug Company 31e6b0c7-1d4a-4660-ae87-9d18e0001dcd 2024-12-19 Warnings Exact identifier application number: M007 Epsom Salts MAGNESIUM SULFATE NEW PRIDE CORP f6626023-4857-518b-e053-2a95a90a9821 2024-12-19 Warnings Exact identifier application number: M007 MILK OF MAGNESIA CHERRY MAGNESIUM HYDROXIDE WALGREEN COMPANY 5fae9b56-2555-b583-e053-2991aa0a8d59 2024-12-19 Warnings Exact identifier application number: M007 MILK OF MAGNESIA MAGNESIUM HYDROXIDE WALGREEN COMPANY 5faf2ed0-dd71-17c9-e053-2a91aa0ab75a 2024-12-19 Warnings Exact identifier application number: M007 Stimulant Laxative Plus Stool Softener DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG RUGBY LABORATORIES f5afd8eb-d35d-44ab-897d-1d41c98ca138 2024-12-19 Warnings Exact identifier application number: M007 Goodsense Fiber METHYLCELLULOSE GoodSense 96ed1ba1-7f91-4912-a549-a4be2c3e0362 2024-12-19 Warnings Exact identifier application number: M007 Senexon-S DOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MG RUGBY LABORATORIES 2e758ff1-3083-4245-8f58-1c47b042bfdd 2024-12-19 Warnings Exact identifier application number: M007
DailyMed RxNorm Mappings# 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