Home NDC 69452-541 stimulant laxative
Product NDC 69452-541
11-digit product format 694520541
Labeler code 69452
Product ID 69452-541_4b1f7db3-c6a9-7f6a-e063-6394a90a5829
Type HUMAN OTC DRUG
Nonproprietary name bisacodyl
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler BIONPHARMA INC.
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-02-23
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 2027-12-31
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 stimulant laxative
Listing expiration 2027-12-31 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 69452-541-83 stimulant laxative 300 in 1 BOTTLE TABLET, DELAYED RELEASE 300 1
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 14 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69452-541-83 69452054183 300 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-541-83) 2026-02-23 No No Current