NDC 58198-0813 - Surolan
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
- 58198-0813
- Package NDCs from labels
- 58198-0813-1, 58198-0813-2
- Manufacturer
- Elanco US Inc. | Olan SpA | EuroAPI France | Xellia Pharmaceuticals ApS | LUSOMEDICAMENTA - SOCIEDADE TÉCNICA FARMACÊUTICA, S.A.
- Effective date
- 2022-11-03
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Surolan™ Rx otic suspension (miconazole nitrate, polymyxin B sulfate, prednisolone acetate) | Elanco US Inc. | Olan SpA | EuroAPI France | Xellia Pharmaceuticals ApS | LUSOMEDICAMENTA - SOCIEDADE TÉCNICA FARMACÊUTICA, S.A. | 2022-11-03 | PRESCRIPTION ANIMAL DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58198-0813-1 | Surolan | 15 mL in 1 BOTTLE, WITH APPLICATOR | SOLUTION/ DROPS | 15 | 3 | |
| 58198-0813-1 | Surolan | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 3 | |
| 58198-0813-2 | Surolan | 30 mL in 1 BOTTLE, WITH APPLICATOR | SOLUTION/ DROPS | 30 | 3 | |
| 58198-0813-2 | Surolan | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58198-0813 | SUROLAN (MICONAZOLE NITRATE, POLYMYXIN B SULFATE, PREDNISOLONE ACETATE) SOLUTION/ DROPS [ELANCO US INC.] | 3 | 4 package rows | 20221111_d8ab8c22-4667-4577-a0b7-166c86477a4e.zip |
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 |
|---|---|---|---|---|---|---|
| ProCure Antifungal | MICONAZOLE NITRATE 2% | Twin Med LLC | 3d380fe4-a870-cb55-e063-6394a90a9c90 | 2026-01-28 | Warnings | VW4H1CYW1K |
| Foot Powder | MICONAZOLE NITRATE | Walgreens Company | 137a493b-6ed5-d649-e063-6294a90ac442 | 2026-01-28 | Warnings | VW4H1CYW1K |
| Polymyxin B Sulfate and Trimethoprim | POLYMYXIN B SULFATE AND TRIMETHOPRIM | REMEDYREPACK INC. | 2a040ba4-54bd-41e4-b519-01ca6a59658f | 2026-01-27 | Warnings, Adverse reactions | 19371312D4 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | ProStat First Aid, LLC. | 4963f926-3d48-36de-e063-6294a90a9acc | 2026-01-27 | Warnings | 19371312D4 |
| Miconazole Nitrate | JOCK ITCH SPRAY | Wal-Mart Stores, Inc. | 76259769-9923-4856-a160-a738bc8a72f0 | 2026-01-27 | Warnings | VW4H1CYW1K |
| Drs. Pharmacy Triple Antibiotic AND BURN RELIEF | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | OL PHARMA TECH, LLC Drs PHARMACY | 4928d9dd-542b-fe8b-e063-6294a90a9252 | 2026-01-22 | Warnings | 19371312D4 |
| Neomycin and Polymyxin B Sulfates and Dexamethasone | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE | NuCare Pharmaceuticals,Inc. | c3b6004a-8cfc-d5f8-e053-2a95a90a3efb | 2026-01-21 | Warnings, Adverse reactions | 19371312D4 |
| Miconazole Nitrate | MICONAZOLE NITRATE | AvKARE | 1a26534d-eeb8-8d17-e063-6294a90a70c7 | 2026-01-19 | Warnings | VW4H1CYW1K |
| Neomycin and Polymyxin B Sulfates and Dexamethasone | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE | Preferred Pharmaceuticals Inc. | e42d4837-77c2-40c3-8705-20966a51a822 | 2026-01-19 | Warnings, Adverse reactions | 19371312D4 |
| Lotrimin Antifungal | MICONAZOLE NITRATE | Bayer HealthCare LLC. | cebd222c-074f-443c-bd37-612114b27bbd | 2026-01-16 | Warnings | VW4H1CYW1K |
| Lotrimin AF Jock Itch | MICONAZOLE NITRATE | Bayer HealthCare LLC. | 1300d84f-d7ff-ec57-e063-6294a90ae0de | 2026-01-16 | Warnings | VW4H1CYW1K |
| Antifungal Ringworm Treatment | MICONAZOLE NITRATE | Rida LLC | eb953281-cf86-44cf-a3d1-37b8d344a6bc | 2026-01-15 | Warnings | VW4H1CYW1K |
| ElixirTripleGuard Triple Antibiotic | MICONAZOLE NITRATE CREAM | ELIXIR HEALTHCARE USA, LLC. | 0482ce9f-c98a-4f37-8b37-6df1738b6da3 | 2026-01-15 | Warnings | VW4H1CYW1K |
| Bacitracin Zinc and Polymyxin B Sulfate | BACITRACIN ZINC AND POLYMYXIN B SULFATE | A-S Medication Solutions | 19b4cfab-5927-47c5-a032-58ab2998d9c7 | 2026-01-13 | Warnings, Adverse reactions | 19371312D4 |
| Desenex | MICONAZOLE NITRATE | Crown Laboratories | 09964187-12f1-bbe6-e063-6394a90acba0 | 2026-01-12 | Warnings | VW4H1CYW1K |
| Zeasorb Jock Itch | MICONAZOLE NITRATE | Crown Laboratories | 09d088ef-aab3-5565-e063-6394a90af263 | 2026-01-12 | Warnings | VW4H1CYW1K |
| Zeasorb Athletes Foot | MICONAZOLE NITRATE | Crown Laboratories | 09bb313e-90cb-5629-e063-6294a90ac268 | 2026-01-12 | Warnings | VW4H1CYW1K |
| Desenex Antifungal Foot Cream | MICONAZOLE NITRATE | Crown Laboratories, Inc. | 311abb56-e176-0510-e063-6294a90a97f5 | 2026-01-12 | Warnings | VW4H1CYW1K |
| Neomycin and Polymyxin B Sulfates and Hydrocortisone | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE | REMEDYREPACK INC. | 04fe1b32-adfb-4c36-a986-d81b49497e0f | 2026-01-12 | Warnings, Adverse reactions | 19371312D4 |
| miconazole nitrate | MICONAZOLE NITRATE | AvPAK | eaf016f6-b631-af00-e053-2a95a90adc7b | 2026-01-09 | Warnings | VW4H1CYW1K |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.