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 30 of 42 · 833 matching rows.
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