Home NDC 58980-415 Stratuscare Bisacodyl
Product NDC 58980-415
11-digit product format 589800415
Labeler code 58980
Product ID 58980-415_2fb66f5b-068d-4125-a66e-670ee944891b
Type HUMAN OTC DRUG
Nonproprietary name Bisacodyl
Dosage form SUPPOSITORY
Route RECTAL
Labeler Stratus Pharmaceuticals
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-05-30
Substance BISACODYL
Active strength 10 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 Stratuscare Bisacodyl
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISACODYL 10 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 198509 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 58980-415-04 Stratuscare Bisacodyl 4 in 1 BOX SUPPOSITORY 4 5 58980-415-08 Stratuscare Bisacodyl 8 in 1 BOX SUPPOSITORY 8 5 58980-415-12 Stratuscare Bisacodyl 12 in 1 BOX SUPPOSITORY 12 5 58980-415-16 Stratuscare Bisacodyl 1 in 1 BOX SUPPOSITORY 1 5 58980-415-16 Stratuscare Bisacodyl 16 in 1 BLISTER PACK SUPPOSITORY 16 5 58980-415-50 Stratuscare Bisacodyl 1 in 1 BOX SUPPOSITORY 1 5 58980-415-50 Stratuscare Bisacodyl 50 in 1 BLISTER PACK SUPPOSITORY 50 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58980-415 STRATUSCARE BISACODYL (BISACODYL) SUPPOSITORY [STRATUS PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 7 package rows 20250418_795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2d.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 30 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 58980-415-04 58980041504 4 BLISTER PACK in 1 BOX (58980-415-04) / 1 SUPPOSITORY in 1 BLISTER PACK 4 blister pack 2014-05-30 0000-00-00 No No Current 58980-415-08 58980041508 8 BLISTER PACK in 1 BOX (58980-415-08) / 1 SUPPOSITORY in 1 BLISTER PACK 8 blister pack 2014-05-30 0000-00-00 No No Current 58980-415-12 58980041512 12 BLISTER PACK in 1 BOX (58980-415-12) / 1 SUPPOSITORY in 1 BLISTER PACK 12 blister pack 2014-05-30 0000-00-00 No No Current 58980-415-16 58980041516 16 BLISTER PACK in 1 BOX (58980-415-16) / 1 SUPPOSITORY in 1 BLISTER PACK 16 blister pack 2025-05-01 No No Current 58980-415-50 58980041550 50 BLISTER PACK in 1 BOX (58980-415-50) / 1 SUPPOSITORY in 1 BLISTER PACK 50 blister pack 2020-06-01 No No Current