NDC 58198-0796-4 - Itrafungol
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
- 58198-0796
- Requested NDC
- 58198-0796-4
- Package NDCs from labels
- 58198-0796-4
- Manufacturer
- Elanco US Inc. | SMS Pharmaceuticals Limited | Lusomedicamenta Sociedade Tecnica Farmaceutica S.A
- Effective date
- 2020-04-30
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Itrafungol™ (itraconazole oral solution) | Elanco US Inc. | SMS Pharmaceuticals Limited | Lusomedicamenta Sociedade Tecnica Farmaceutica S.A | 2020-04-30 | PRESCRIPTION ANIMAL DRUG LABEL |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| KUGIG ALOE FOAMING INTIMATE WASH | INTIMATE CLEANSING FOAM | Hong Kong KangXing Centennial Management Limited | 59f4d398-1186-a168-e063-6294a90ab44b | 2026-08-26 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | REMEDYREPACK INC. | 5dd5d148-6e23-41de-bff5-551b2aea9598 | 2026-08-24 | Warnings, Adverse reactions | 059QF0KO0R |
| Rohto Optic Glow | NAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOL | The Mentholatum Company | df9c5f7c-96e6-4b2b-b8cb-21a6a3342dff | 2026-08-20 | Warnings | 6DC9Q167V3 |
| Rohto Preservative Free Dry Aid | POVIDONE, PROPYLENE GLYCOL | The Mentholatum Company | f4b1974c-2412-45f6-b79d-88b8a0bcb608 | 2026-08-18 | Warnings | 6DC9Q167V3 |
| Rohto Dry-Aid | POVIDONE, PROPYLENE GLYCOL | The Mentholatum Company | 8ea5c6c9-48f4-406a-a2cb-9280c546d87d | 2026-08-18 | Warnings | 6DC9Q167V3 |
| Itraconazole | ITRACONAZOLE | Rising Pharma Holdings, Inc. | 6df5ff94-47ba-4881-abb4-b321e35a6955 | 2026-08-18 | Boxed warning, Warnings, Adverse reactions | 304NUG5GF4 |
| BM BM63 DROPS | CEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADEN | BM Private Limited | 59006d82-610a-2e08-e063-6394a90af1ed | 2026-08-14 | Warnings | 059QF0KO0R |
| SYSTANE HYDRATION PF PRESERVATIVE FREE | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 8936f66f-10fe-44ab-a26e-dd8b05dfa997 | 2026-08-10 | Warnings | 6DC9Q167V3 |
| Systane Pro PF | PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 23b3515f-fbe5-4398-b2df-8b2eccdd01e2 | 2026-08-10 | Warnings | 6DC9Q167V3 |
| Sterile Water | WATER | Cardinal Health 107, LLC | 48d75a7c-8329-48a8-bea0-a8c144ddf637 | 2026-08-07 | Warnings, Adverse reactions | 059QF0KO0R |
| Leader Lubricant Eye Drops 30ct | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | CARDINAL HEALTH 110, LLC. DBA LEADER | 8df69f2c-40c4-245c-e053-2a95a90a5406 | 2026-08-05 | Warnings | 6DC9Q167V3 |
| Itraconazole | ITRACONAZOLE | Amneal Pharmaceuticals LLC | 43ded1aa-f825-40fe-aa9a-addd36a07f06 | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | 304NUG5GF4 |
| ITRACONAZOLE | ITRACONAZOLE | Alembic Pharmaceuticals Inc. | 23126370-8d6a-4027-bd8f-860e2776ba3a | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | 304NUG5GF4 |
| Garzulys | INSULIN ASPART-FSAN | Meitheal Pharmaceuticals Inc. | 30c64769-d2f7-4604-ac9e-2a6bc09506c9 | 2026-07-31 | Warnings, Adverse reactions | 059QF0KO0R |
| Itraconazole | ITRACONAZOLE | Torrent Pharmaceuticals Limited | b1274d78-1096-4ae3-8299-a2e94eaa0ea5 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | 304NUG5GF4 |
| DECONIMO Reconstitution | DECONIMO RECONSTITUTION | Image Amazon LLC | 57ab9b1c-9a18-3786-e063-6394a90a2c63 | 2026-07-28 | Warnings | 059QF0KO0R |
| Neutraflush | EYEWASH STATION ADDITIVE CONCENTRATE | Aero Healthcare | 1d9ff2ef-9c9b-f367-e063-6294a90afa0e | 2026-07-24 | Warnings | 6DC9Q167V3 |
| Itraconazole | ITRACONAZOLE | Amneal Pharmaceuticals LLC | 2ab38a8a-3708-4b97-9f7f-8e554a15348d | 2026-07-22 | Boxed warning, Warnings, Adverse reactions | 304NUG5GF4 |
| Sterile Water | WATER | Cardinal Health 107, LLC | 9655cd02-82b5-4a75-813b-854b19551481 | 2026-07-21 | Warnings, Adverse reactions | 059QF0KO0R |
| FUNGAL NAIL TREATMENT kit .cream. | PSEUDOLARIX AMABILIS BARK 1% | GETHSEMANE BRANCH CORPORATION | 56c9d9fa-09ad-e26a-e063-6394a90a0ed9 | 2026-07-17 | Warnings | 6DC9Q167V3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.