NDC 57237-337-51 - 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
57237-337-51
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 2 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentle LaxativeBISACODYLFamily Dollar Services Inccffa0a9d-8353-432c-b098-318a2c43d7112026-06-16WarningsExact identifier
unii: 10X0709Y6I
LaxativeBISACODYLFamily Dollar Services Incaf976b4a-f444-49f4-9843-99638ed07d362026-06-16WarningsExact identifier
unii: 10X0709Y6I
Gentle LaxativeBISACODYLUnited Natural Foods, Inc. dba UNFI1daeccb6-b8ab-43dc-a8fd-07ffc1fc11382026-06-15WarningsExact identifier
unii: 10X0709Y6I
Gentle LaxativeBISACODYLWal-Mart Stores Inc1c27244f-f0e9-43bf-a5fa-f594952914ca2026-06-15WarningsExact identifier
unii: 10X0709Y6I
LaxativeBISACODYLStrategic Sourcing Services LLCc14524f6-1cdf-4212-b6c8-5f2cfc76b4f22026-06-15WarningsExact identifier
unii: 10X0709Y6I
Gentle LaxativeBISACODYLWalgreen Company8a419066-f22d-42e6-a855-b1c36fbb22cf2026-06-15WarningsExact identifier
unii: 10X0709Y6I
Gentle LaxativeBISACODYLWal-Mart Stores Incea6ce0e8-7e0e-4cce-84d5-84094ddf1f0e2026-06-10WarningsExact identifier
unii: 10X0709Y6I
Stratuscare BisacodylBISACODYLStratus Pharmaceuticals795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2d2026-06-09WarningsExact identifier
rxcui: 198509
unii: 10X0709Y6I
Gentle LaxativeBISACODYLCardinal Health 110, LLC. DBA Leadera82d21a9-1c40-447d-a880-4804e889459a2026-06-09WarningsExact identifier
unii: 10X0709Y6I
LaxativeBISACODYLPublix Super Markets Inc4460b4c3-fd53-4067-8845-55b6bdc446092026-05-28WarningsExact identifier
unii: 10X0709Y6I
LaxativeBISACODYLHHH Pharmaceuticalsafb39544-c509-490c-ad42-ba68ebbf986b2026-05-06WarningsExact identifier
unii: 10X0709Y6I
Gentle LaxativeBISACODYLTopco Associates, LLCe4ff1277-b859-4c34-872f-0dc5b78791212026-04-27WarningsExact identifier
unii: 10X0709Y6I
BISACODYLBISACODYLAARNA USA INC.50109967-69af-5fc5-e063-6394a90a87512026-04-22WarningsExact identifier
rxcui: 198509
unii: 10X0709Y6I
LaxativeBISACODYLTOPCO ASSOCIATES LLCdcb1b698-a6ac-4820-8e51-67256634e73f2026-04-22WarningsExact identifier
unii: 10X0709Y6I
BisacodylBISACODYLCardinal Health 107, LLC49cb9a34-4c76-48c5-92c0-39e0ffc805c32026-04-14WarningsExact identifier
unii: 10X0709Y6I
Gentle LaxativeBISACODYLCVS Pharmacy916339d0-aee1-425c-a5f1-8d02176992202026-04-09WarningsExact identifier
unii: 10X0709Y6I
Gentle LaxativeBISACODYLDOLGENCORP, LLC9fccd9f0-5621-433a-a52b-f647b00d37e32026-04-09WarningsExact identifier
unii: 10X0709Y6I
laxative for womenBISACODYLRite Aid Corporationfeae105a-6bee-4895-82be-2dd8a4bc033c2026-04-08WarningsExact identifier
unii: 10X0709Y6I
C-Lax LaxativeBISACODYLCVS Pharmacy46e59908-fed4-4e24-a148-ca75164d977a2026-03-24WarningsExact identifier
unii: 10X0709Y6I
LaxomilBISACODYL 5MGPharmadel LLC3999935b-d8e8-52a6-e063-6294a90aa2a22026-03-20WarningsExact identifier
unii: 10X0709Y6I

Reported adverse events (FAERS/openFDA)#

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