Home NDC 55758-504 Laxomil
Product NDC 55758-504
11-digit product format 557580504
Labeler code 55758
Product ID 55758-504_4d7abf05-8f42-a9a5-e063-6394a90a579d
Type HUMAN OTC DRUG
Nonproprietary name Bisacodyl 5mg
Dosage form TABLET, COATED
Route ORAL
Labeler Pharmadel LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-10
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 Laxomil
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308753 Internal RxNorm lookup 2719716 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 55758-504-01 Laxomil 1 in 1 CARTON TABLET, COATED 1 2 55758-504-01 Laxomil 24 in 1 BLISTER PACK TABLET, COATED 24 2
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 55758-504-01 55758050401 1 BLISTER PACK in 1 CARTON (55758-504-01) / 24 TABLET, COATED in 1 BLISTER PACK 1 blister pack 2025-07-10 No No Current