Home NDC 57237-337 Proctozone-B
Product NDC 57237-337
11-digit product format 572370337
Labeler code 57237
Product ID 57237-337_ad7d1357-40a1-47d3-bb30-77aaf1547659
Type HUMAN OTC DRUG
Nonproprietary name Bisacodyl
Dosage form SUPPOSITORY
Route RECTAL
Labeler Rising Pharma Holdings, Inc.
Application M007.60
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-01
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 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Proctozone-B
Listing expiration 2026-12-31 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 57237-337-03 Proctozone-B 6 in 1 CARTON SUPPOSITORY 6 2 57237-337-04 Proctozone-B 4 in 1 BLISTER PACK SUPPOSITORY 4 2 57237-337-21 Proctozone-B 3 in 1 CARTON SUPPOSITORY 3 2 57237-337-51 Proctozone-B 5 in 1 BLISTER PACK SUPPOSITORY 5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57237-337 PROCTOZONE-B (BISACODYL) SUPPOSITORY [RISING PHARMA HOLDINGS, INC.] 2 Current NDC, 4 package rows 20241202_c53ed934-3846-4dc8-b97b-c84171c21ae1.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 1 of 1 · 1 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 57237-337-03 57237033703 6 BLISTER PACK in 1 CARTON (57237-337-03) / 5 SUPPOSITORY in 1 BLISTER PACK (57237-337-51) 6 blister pack 2025-02-01 No No Current 57237-337-04 57237033704 4 in 1 BLISTER PACK Historical 57237-337-21 57237033721 3 BLISTER PACK in 1 CARTON (57237-337-21) / 4 SUPPOSITORY in 1 BLISTER PACK (57237-337-04) 3 blister pack 2024-12-01 No No Current 57237-337-51 57237033751 5 in 1 BLISTER PACK Historical