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 |
|---|---|---|---|---|---|---|
| RoyceDerm Anti-Fungal Cream | MICONAZOLE NITRATE 2% | RoyceDerm LLC | 4e861073-88e8-b2f7-e063-6394a90ab94a | 2026-04-02 | Warnings | VW4H1CYW1K |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | H E B | 2a143950-13b4-457e-91a4-c61a88aad84b | 2026-04-02 | Warnings | 19371312D4 |
| Miconazole Nitrate | JOCK ITCH SPRAY | CVS Pharmacy | 7b70d3ea-126a-42aa-8509-b982893c710b | 2026-04-01 | Warnings | VW4H1CYW1K |
| Baza Antifungal | MICONAZOLE NITRATE | Coloplast Corp | 75182cb7-840a-423a-9c20-10840d6e1d65 | 2026-03-31 | Warnings | VW4H1CYW1K |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | ProStat First Aid, LLC. | 4e54f479-ad87-e86b-e063-6394a90aa6d2 | 2026-03-31 | Warnings | 19371312D4 |
| MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | MICONAZOLE NITRATE | Trifecta Pharmaceuticals Usa Llc | 80217dbb-a0f0-414a-8d22-a9a346b017aa | 2026-03-31 | Warnings | VW4H1CYW1K |
| Critic Aid Clear AF | MICONAZOLE NITRATE | Coloplast Corp | cbc5d976-850a-476e-b179-b7a5a8675524 | 2026-03-31 | Warnings | VW4H1CYW1K |
| Doctor Jiao Antifungal Cream | MICONAZOLE NITRATE | Jiangxi Haiwei Pharmaceutical Co., Ltd. | 4e3b231e-0642-bf63-e063-6394a90a905b | 2026-03-30 | Warnings | VW4H1CYW1K |
| Miconazole Nitrate | ATHLETES FOOT POWDER SPRAY TALC FREE | CVS Pharmacy | 3380263d-ee7b-4946-a467-35a24789a901 | 2026-03-27 | Warnings | VW4H1CYW1K |
| Micro-Guard (AF) | MICONAZOLE NITRATE | Coloplast Corp | a43a94d0-fec0-470f-bdb4-535dcce6d1e0 | 2026-03-27 | Warnings | VW4H1CYW1K |
| Hermon Jock Itch Antifungal Treatment Cream | MICONAZOLE NITRATE 2% | Beautivity LLC | 4dbc521c-2f5f-9736-e063-6294a90ad85d | 2026-03-23 | Warnings | VW4H1CYW1K |
| Triple Antifungal | MICONAZOLE NITRATE | Advantice Health, LLC | 9a47fb1b-a41f-4c8a-8e43-7332853c308e | 2026-03-19 | Warnings | VW4H1CYW1K |
| Antibiotic and Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | f7aa9330-c47c-4d2f-b784-11b831d919d6 | 2026-03-18 | Warnings | 19371312D4 |
| Neomycin and Polymyxin B Sulfates | NEOMYCIN AND POLYMYXIN B SULFATES | XGen Pharmaceuticals DJB, Inc. | a2f47d77-efd3-4c84-a364-08fb6d9978eb | 2026-03-18 | Warnings, Adverse reactions | 19371312D4 |
| Antifungal | MICONAZOLE NITRATE | Dynarex Corporation | 4d384385-f3c5-09ba-e063-6394a90aec7f | 2026-03-17 | Warnings | VW4H1CYW1K |
| Bacitracin Zinc and Polymyxin B Sulfate | BACITRACIN ZINC AND POLYMYXIN B SULFATE | A-S Medication Solutions | 51f6eac3-205e-4beb-8522-6ba2c593f350 | 2026-03-17 | Warnings, Adverse reactions | 19371312D4 |
| Miconazole 7 | MICONAZOLE NITRATE | Family Dollar (FAMILY WELLNESS) | c0249750-551a-4ab3-b5f1-409957889c8e | 2026-03-16 | Warnings | VW4H1CYW1K |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | ProStat First Aid, LLC. | 4cd49c65-e347-7589-e063-6394a90a53bd | 2026-03-12 | Warnings | 19371312D4 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | ProStat First Aid, LLC. | 4cc6d822-f383-2ceb-e063-6294a90aecc7 | 2026-03-11 | Warnings | 19371312D4 |
| Ora Zen Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Orazen Inc | abbf8c34-87cb-4366-9840-7264a5114b54 | 2026-03-11 | Warnings | 19371312D4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.