warnings
Warnings For rectal use only
FARGELIN HEMORRHOIDAL
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
- FARGELIN HEMORRHOIDAL
- Generic name
- CALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDE
- Manufacturer
- MADISON ONE ACME INC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 6844ad63-512d-496a-9458-011894185b0d
- SPL ID
- 43466548-41d6-9d96-e063-6294a90acd67
- Version
- 6
- Effective date
- 2025-11-10
- Source export date
- 2026-09-28
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:15:20
| Harmonized routes |
|---|
| RECTAL, TOPICAL |
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 | M015 | openfda.application_number | |
| brand name | FARGELIN HEMORRHOIDAL | openfda.brand_name | |
| generic name | CALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | MADISON ONE ACME INC | openfda.manufacturer_name | |
| ndc | package | 55614-610-01 | openfda.package_ndc |
| ndc | product | 55614-610 | openfda.product_ndc |
| ndc11 | package | 55614061001 | derived:openfda.package_ndc |
| spl id | 43466548-41d6-9d96-e063-6294a90acd67 | id | |
| spl set id | 6844ad63-512d-496a-9458-011894185b0d | set_id | |
| unii | 4T6H12BN9U | openfda.unii | |
| unii | 04JA59TNSJ | openfda.unii | |
| unii | SOI2LOH54Z | openfda.unii | |
| unii | 1K09F3G675 | 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.