Home NDC 69168-404 Laxative
Product NDC 69168-404
11-digit product format 691680404
Labeler code 69168
Product ID 69168-404_755e478f-3c15-4175-9f32-45d2a751e282
Type HUMAN OTC DRUG
Nonproprietary name Bisacodyl 5mg
Dosage form TABLET, SUGAR COATED
Route ORAL
Labeler Allegiant Health
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2002-03-25
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 Laxative
Brand name suffix Enteric Coated
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 69168-404-03 LaxativeEnteric Coated 250 in 1 BOTTLE TABLET, SUGAR COATED 250 4 69168-404-32 LaxativeEnteric Coated 100 in 1 BOTTLE TABLET, SUGAR COATED 100 4 69168-404-92 LaxativeEnteric Coated 1 in 1 CARTON TABLET, SUGAR COATED 1 4 69168-404-92 LaxativeEnteric Coated 25 in 1 BLISTER PACK TABLET, SUGAR COATED 25 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-404 LAXATIVE ENTERIC COATED (BISACODYL 5MG) TABLET, SUGAR COATED [ALLEGIANT HEALTH] 4 Current NDC, Legacy NDC, 4 package rows 20231115_51f1c6c0-770c-4426-820b-bc1f42e143fd.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 17 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 Marketing end Sample Exclude flag Status 69168-404-03 69168040403 250 TABLET, SUGAR COATED in 1 BOTTLE (69168-404-03) 2002-03-25 0000-00-00 No No Current 69168-404-32 69168040432 100 TABLET, SUGAR COATED in 1 BOTTLE (69168-404-32) 2022-05-18 0000-00-00 No No Current 69168-404-92 69168040492 1 BLISTER PACK in 1 CARTON (69168-404-92) / 25 TABLET, SUGAR COATED in 1 BLISTER PACK 1 blister pack 2002-03-25 0000-00-00 No No Current