Home NDC 85828-404 Laxative
Product NDC 85828-404
11-digit product format 858280404
Labeler code 85828
Product ID 85828-404_1595c8c4-99c4-4cad-9d6c-2015abe15570
Type HUMAN OTC DRUG
Nonproprietary name Bisacodyl 5mg
Dosage form TABLET, COATED
Route ORAL
Labeler Grocery Outlet
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-19
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 Laxative
Brand name suffix Enteric Coated
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 85828-404-92 LaxativeEnteric Coated 1 in 1 CARTON TABLET, COATED 1 1 85828-404-92 LaxativeEnteric Coated 25 in 1 BLISTER PACK TABLET, COATED 25 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 Units Marketing start Sample Exclude flag Status 85828-404-92 85828040492 1 BLISTER PACK in 1 CARTON (85828-404-92) / 25 TABLET, COATED in 1 BLISTER PACK 1 blister pack 2026-03-19 No No Current