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 |
|---|---|---|---|---|---|---|
| FGPER ANTIFUNGAL | MICONAZOLE NITRATE | Guangzhou ChuanMa International Trading Co.,Ltd. | 5ced6af9-f9c4-6e62-e063-6294a90a0e11 | 2026-10-03 | Warnings | VW4H1CYW1K |
| polymyxin b sulfate and trimethoprim sulfate | POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE | REMEDYREPACK INC. | c68818b2-d849-41d2-be07-731244afbbac | 2026-09-09 | Warnings, Adverse reactions | 19371312D4 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | NuCare Pharmaceutical, Inc. | 5b14499e-e45c-7c05-e063-6294a90a1cc2 | 2026-09-09 | Warnings | 19371312D4 |
| Medline | MICONAZOLE NITRATE | Medline Industries, LP | 0d997d1d-8663-201f-e063-6394a90a285e | 2026-09-08 | Warnings | VW4H1CYW1K |
| Remedy Antifungal With Olivamine | MICONAZOLE NITRATE | Medline Industries, LP | 28c5183e-05b4-1754-e054-00144ff8d46c | 2026-09-08 | Warnings | VW4H1CYW1K |
| American Safety and First Aid Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Orazen Inc | eb0df2da-1688-c477-e053-2995a90a74a2 | 2026-09-07 | Warnings | 19371312D4 |
| American Safety and First Aid Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Orazen Inc | eb0d108f-42bf-3364-e053-2a95a90a4542 | 2026-09-07 | Warnings | 19371312D4 |
| Inlifay ANTIFUNGAL | MICONAZOLE NITRATE 2% ANTIFUNGAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a832f39-ac11-d8b3-e063-6394a90acb39 | 2026-09-06 | Warnings | VW4H1CYW1K |
| Jock Itch Powder | MICONAZOLE NITRATE | Premier Brands of America Inc | 5aaacc88-6752-ab47-e063-6394a90af7cd | 2026-09-04 | Warnings | VW4H1CYW1K |
| MEDI-FIRST | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Orazen Inc | f4e4d0a4-b90c-99b0-e053-2995a90ab423 | 2026-09-04 | Warnings | 19371312D4 |
| Lil Drug Store Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | ORAZEN INC | e6e5263b-328f-4775-9fac-34302f050ce0 | 2026-09-04 | Warnings | 19371312D4 |
| MEDI-FIRST | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Orazen Inc | f4e42c5c-e080-4efb-e053-2a95a90af52e | 2026-09-04 | Warnings | 19371312D4 |
| MEDI-FIRST | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Orazen Inc | f4e4854a-ee01-df72-e053-2995a90aa8ea | 2026-09-04 | Warnings | 19371312D4 |
| Circle K Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | ORAZEN INC | 84c3f7e4-b28b-40bb-8d9d-7c8d679e3a3a | 2026-09-04 | Warnings | 19371312D4 |
| First Aid Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL | Walgreen Company | b982091a-5aa0-4bbc-bb1d-08016f6d0a70 | 2026-09-03 | Warnings | 19371312D4 |
| triple antibiotic | BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B | Walgreen Company | 4f3cfe39-2df8-48b4-954d-5997217c92ba | 2026-08-31 | Warnings | 19371312D4 |
| First Aid Antibiotic | BACITRACIN ZINC | NINGBO TIANBO FIRST AID PRODUCT CO., LTD. | 217aa2b8-94f5-468a-99b4-52824a77b573 | 2026-08-28 | Warnings | 19371312D4 |
| OP Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Yiwu Ori-Power Medtech Co., Ltd. | 03f3cce9-7e9f-90a6-e063-6294a90a660b | 2026-08-28 | Warnings | 19371312D4 |
| Gembooxt RINGWORM Cream | MICONAZOLE NITRATE, HYDROCORTISONE | Guangdong Quadrant Ecological Technology Co., Ltd. | 464a33c3-6d16-0cfd-e063-6294a90abf4b | 2026-08-27 | Warnings | VW4H1CYW1K |
| Miconazole Nitrate | MICONAZOLE NITRATE | Sun Pharmaceutical Industries, Inc. | 7fd4037e-d350-47b7-a7d9-a43b8e366fa0 | 2026-08-25 | Warnings | VW4H1CYW1K |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.