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 6 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ConlaxBISACODYLBliss GVS Pharma Limited7d25990b-6f7c-1eac-e053-2a91aa0a70222024-12-21WarningsExact identifier
rxcui: 198509
unii: 10X0709Y6I
Bliss GVS HemorrhoidalHARD FAT, PHENYLEPHRINE HCLBliss GVS Pharma Limited88c49f6c-2a48-2dae-e053-2a95a90af20a2024-12-19WarningsExact identifier
unii: 8334LX7S21
Good Neighbor Pharmacy Gentle LaxativeBISACODYLAmerisourceBergen Drug Corp8336d821-ec70-468e-98b2-512a9a7212e02024-12-18WarningsExact identifier
rxcui: 198509
unii: 10X0709Y6I
Dollar General Gentle LaxativeBISACODYLDolgencorp, LLCf1977a2e-942a-49eb-8d0f-cdb67b020a262024-12-18WarningsExact identifier
rxcui: 198509
unii: 10X0709Y6I
Discount Drugmart Gentle LaxativeBISACODYLDiscount Drug Mart, Incb525a0a9-f97c-4406-8360-58e87e44cfce2024-12-18WarningsExact identifier
rxcui: 198509
unii: 10X0709Y6I
HEB Gentle LaxativeBISACODYLH E B3d163d71-93c7-419f-9707-5811aa6474fb2024-12-18WarningsExact identifier
rxcui: 198509
unii: 10X0709Y6I
Meijer Gentle LaxativeBISACODYLMeijer Distribution Inc.b49786a1-f0b9-45ae-b8f6-683489c54e762024-12-18WarningsExact identifier
rxcui: 198509
unii: 10X0709Y6I
Foster and Thrive Gentle LaxativeBISACODYLStrategic Sourcing Services LLCd03c2c42-d9d9-4b4b-a6ae-31d99425a2282024-12-18WarningsExact identifier
rxcui: 198509
unii: 10X0709Y6I
stimulant laxative enteric coatedBISACODYLGeri-Care Pharmaceutical Corpc3fa1050-bb8b-449c-89e6-f5fd508278d22024-11-28WarningsExact identifier
unii: 10X0709Y6I
Proctozone-BBISACODYLRising Pharma Holdings, Inc.c53ed934-3846-4dc8-b97b-c84171c21ae12024-10-22WarningsExact identifier
ndc (package): 57237-337-03
ndc (package): 57237-337-21
ndc (package): 57237-337-04
ndc (package): 57237-337-51
ndc (product): 57237-337
ndc11 (package): 57237033704
rxcui: 198509
spl id: ad7d1357-40a1-47d3-bb30-77aaf1547659
spl set id: c53ed934-3846-4dc8-b97b-c84171c21ae1
unii: 10X0709Y6I
BisacodylBISACODYLPadagis US LLC7eada0fc-5f83-43da-a56f-b0f5372982082024-10-10WarningsExact identifier
rxcui: 198509
unii: 10X0709Y6I
BISACODYLBISCODYLTARGET CORPORATION8ed281d5-b17e-e3bb-e053-2995a90a25902024-07-15WarningsExact identifier
unii: 10X0709Y6I
FleetBISACODYLC.B. Fleet Company, Inc.4e0d973f-e6dc-48d9-8df3-1d47c87840f12024-06-21WarningsExact identifier
unii: 10X0709Y6I
Dulcolax LaxativeBISACODYLChattem, Inc.016a4920-77a7-4ac3-8d9d-fd2f564dfee62024-02-01WarningsExact identifier
rxcui: 198509
unii: 10X0709Y6I
stimulant laxative enteric coatedBISACODYLBryant Ranch Prepack06940a9d-02bb-4b8e-b1cf-d69d94a30b672024-01-19WarningsExact identifier
unii: 10X0709Y6I
WOMENS LAXATIVE ENTERIC COATEDBISACODYLCARDINAL HEALTHab34bc89-6738-d284-e053-2a95a90a5dc92024-01-11WarningsExact identifier
unii: 10X0709Y6I
Gentle LaxativeBISACODYLCARDINAL HEALTH97b83b7a-1a41-71e7-e053-2995a90ac6402023-12-06WarningsExact identifier
unii: 10X0709Y6I
SIMPEX Bisacodyl laxativeBISACODYLSimpex Pharma Pvt. Ltd5114ed64-4fec-401b-8a91-8df3e42b10b12023-11-29WarningsExact identifier
unii: 10X0709Y6I
STIMULANT LAXATIVEBISACODYLTIME CAP LABORATORIES, INC.e0a9f8d9-660b-431c-8043-6d8ec81f98e52019-09-27WarningsExact identifier
unii: 10X0709Y6I
Laxative Enteric CoatedBISACODYL 5MGMarc Glassman, Inc.ec34fc1e-d122-4fa4-859e-e89e3e12edd52019-09-18WarningsExact identifier
unii: 10X0709Y6I

Reported adverse events (FAERS/openFDA)#

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