Home NDC 83586-012 Bisacodyl
Product NDC 83586-012
11-digit product format 835860012
Labeler code 83586
Product ID 83586-012_559a7e45-7f25-d813-e063-6394a90a0f90
Type HUMAN OTC DRUG
Nonproprietary name Bisacodyl
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler HHH Pharmaceuticals
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-02
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 Bisacodyl
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.
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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83586-012-00 83586001200 310000 TABLET, DELAYED RELEASE in 1 BOX (83586-012-00) 2026-07-02 No No Current