FDA.reportPublic FDA data

NDC 57237-337-04 - Proctozone-B

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
57237-337
Requested NDC
57237-337-04
Package NDCs from labels
57237-337-04, 57237-337-21, 57237-337-51, 57237-337-03
Manufacturer
Rising Pharma Holdings, Inc.
Effective date
2024-10-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Proctozone-B TM Bisacodyl (USP) Suppositories 10 mgRising Pharma Holdings, Inc.2024-10-22HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-337-03Proctozone-B6 in 1 CARTONSUPPOSITORY62
57237-337-04Proctozone-B4 in 1 BLISTER PACKSUPPOSITORY42
57237-337-21Proctozone-B3 in 1 CARTONSUPPOSITORY32
57237-337-51Proctozone-B5 in 1 BLISTER PACKSUPPOSITORY52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-337PROCTOZONE-B (BISACODYL) SUPPOSITORY [RISING PHARMA HOLDINGS, INC.]2Current NDC, 4 package rows20241202_c53ed934-3846-4dc8-b97b-c84171c21ae1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-337-03EA - Each57237-33768a4090e-9719-4079-bb1d-ca2bd4cdde6012025-08-11
57237-337-04EA - Each57237-33702ae42a8-283d-4e63-a6e0-ce3ab92bf58912025-10-14
57237-337-21EA - Each57237-3376f774f0f-ba01-489f-9d72-aa3e78da545c12025-10-14

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 7 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Womens LaxativeBISACODYLMarc Glassman, Inc.aeb3c49b-cbf5-4a47-b19c-e77fbb987a492019-09-17WarningsExact identifier
unii: 10X0709Y6I
WOMENS GENTLE LAXATIVEBISACODYLTARGET CORPORATION7cabd434-f48f-a16a-e053-2991aa0a2bb32019-04-16WarningsExact identifier
unii: 10X0709Y6I
Bisacodyl 5mgBISACODYL 5MGAllegiant Health46a377f5-822b-496f-a73b-66d8f902680a2019-03-26WarningsExact identifier
unii: 10X0709Y6I
Laxative Enteric CoatedBISACODYL 5MGAllegiant Health51f1c6c0-770c-4426-820b-bc1f42e143fd2019-02-07WarningsExact identifier
unii: 10X0709Y6I

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.