warnings
Warnings For rectal use only
Proctozone-B
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Proctozone-B
- Generic name
- BISACODYL
- Manufacturer
- Rising Pharma Holdings, Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- c53ed934-3846-4dc8-b97b-c84171c21ae1
- SPL ID
- ad7d1357-40a1-47d3-bb30-77aaf1547659
- Version
- 2
- Effective date
- 2024-10-22
- Source export date
- 2026-10-12
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:55:47
| Harmonized routes |
|---|
| RECTAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application number | M007.60 | openfda.application_number | |
| brand name | Proctozone-B | openfda.brand_name | |
| generic name | BISACODYL | openfda.generic_name | |
| manufacturer name | Rising Pharma Holdings, Inc. | openfda.manufacturer_name | |
| ndc | package | 57237-337-03 | openfda.package_ndc |
| ndc | package | 57237-337-21 | openfda.package_ndc |
| ndc | package | 57237-337-04 | openfda.package_ndc |
| ndc | package | 57237-337-51 | openfda.package_ndc |
| ndc | product | 57237-337 | openfda.product_ndc |
| ndc11 | package | 57237033751 | derived:openfda.package_ndc |
| ndc11 | package | 57237033704 | derived:openfda.package_ndc |
| ndc11 | package | 57237033721 | derived:openfda.package_ndc |
| ndc11 | package | 57237033703 | derived:openfda.package_ndc |
| rxcui | 198509 | openfda.rxcui | |
| spl id | ad7d1357-40a1-47d3-bb30-77aaf1547659 | id | |
| spl set id | c53ed934-3846-4dc8-b97b-c84171c21ae1 | set_id | |
| unii | 10X0709Y6I | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.