FDA.reportPublic FDA data

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 5 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BisacodylBISACODYLChain Drug Consortium71215710-f33d-4e01-a543-fc46b5ce51372025-07-21WarningsExact identifier
unii: 10X0709Y6I
Bisacodyl LaxativeBISACODYL LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cb0386-a662-6893-e063-6294a90aa71a2025-07-03WarningsExact identifier
rxcui: 198509
unii: 10X0709Y6I
FleetBISACODYLC.B. Fleet Company, Inc.324e61eb-8f6b-48d7-85c2-b1b5642691c92025-06-23WarningsExact identifier
unii: 10X0709Y6I
Stimulant Laxative Enteric CoatedBISACODYLSDA Laboratories, Inc.017bc27d-a951-48a4-8f65-90fcbe6dbea02025-05-16WarningsExact identifier
unii: 10X0709Y6I
BisacodylBISACODYLRising Pharma Holdings, Inc.03429da4-1ce9-4789-bf54-ce1b3215b0132025-05-13WarningsExact identifier
rxcui: 198509
unii: 10X0709Y6I
Gentle Overnight LaxativeBISACODYLBetter Living Brands, LLC350e3214-2252-4f4f-89b7-386edcfd7bf22025-04-29WarningsExact identifier
unii: 10X0709Y6I
RIGHT REMEDIES OVERNIGHT LaxativeBISACODYLStrive Pharmaceuticals Inc.322beeab-cdff-3a31-e063-6294a90a0c522025-04-25WarningsExact identifier
unii: 10X0709Y6I
Dulcolax Stimulant LaxativeBISACODYLChattem, Inc.f1e4b28a-ed74-4eff-bd10-b2bfaf7483b02025-04-08WarningsExact identifier
unii: 10X0709Y6I
Dulcolax Simulant LaxativeBISACODYLChattem, Inc.d285651b-7ccc-4ae5-a862-7a38dffefa282025-04-01WarningsExact identifier
unii: 10X0709Y6I
BisacodylBISACODYLBryant Ranch Prepack71dea737-3fde-461f-958d-3a39ebdbf1ae2025-03-31WarningsExact identifier
unii: 10X0709Y6I
Womens Gentle LaxativeBISACODYLBETTER LIVING BRANDS LLC.f2c4ed1a-5aa4-1915-e053-2a95a90a59b62025-02-12WarningsExact identifier
unii: 10X0709Y6I
WOMENS GENTLE LAXATIVEBISACODYLCVS HEALTH CORPa95073f3-e1d6-d291-e053-2a95a90aefea2025-02-12WarningsExact identifier
unii: 10X0709Y6I
Extra Gentle LaxativeBISACODYLDOLGENCORP INCbe214c4e-f6db-cc8d-e053-2a95a90addf72025-02-10WarningsExact identifier
unii: 10X0709Y6I
Dulcolax Pink Stimulant LaxativeBISACODYLChattem, Inc.fb5ad666-57b3-4b95-b5de-9db5d265925e2025-02-05WarningsExact identifier
unii: 10X0709Y6I
BisacodylBISACODYL SUPPOSITORIESOncor Pharmaceuticals6f0aefc9-cd5f-4bdd-89c2-b6a80558987c2025-01-24WarningsExact identifier
rxcui: 198509
unii: 10X0709Y6I
LaxativeBISACODYLAdvanced Rx LLCaf2dbf50-f7ac-486d-a636-f8f77d7c880f2025-01-22WarningsExact identifier
unii: 10X0709Y6I
Gentle Laxative BisacodylGENTLE LAXATIVE BISACODYLNeilMed Pharmaceuticals Inc03b3733a-4d78-149f-e063-6294a90a65182025-01-17WarningsExact identifier
rxcui: 198509
unii: 10X0709Y6I
BisacodylBISACODYLAphena Pharma Solutions - Tennessee, LLCca67d5e8-d67d-44ce-adf7-cf9b2eed89d22025-01-10WarningsExact identifier
unii: 10X0709Y6I
stimulant laxative enteric coatedBISACODYLAphena Pharma Solutions - Tennessee, LLC0331c762-d318-48d6-97ed-86499c6c8b302025-01-09WarningsExact identifier
unii: 10X0709Y6I
GOOD REMEDIES GENTLE LaxativeBISACODYLStrive Pharmaceuticals Inc.c8286a71-52a4-4568-a909-b04940aa4bfe2025-01-02WarningsExact identifier
unii: 10X0709Y6I

Reported adverse events (FAERS/openFDA)#

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