FDA.reportPublic FDA data

NDC 58198-0076-2 - BAYTRIL OTIC

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
58198-0076
Requested NDC
58198-0076-2
Package NDCs from labels
58198-0076-1, 58198-0076-2, 58198-0076-3
Manufacturer
Elanco US Inc.
Effective date
2026-05-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BAYTRIL OTIC - Elanco US Inc.Elanco US Inc.2026-05-07PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-0076-1BAYTRIL OTIC15 mL in 1 BOTTLE, DROPPEREMULSION156
58198-0076-2BAYTRIL OTIC12 in 1 CARTONEMULSION126
58198-0076-3BAYTRIL OTIC6 in 1 CARTONEMULSION66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58198-0076BAYTRIL OTIC (ENROFLOXACIN, SILVER SULFADIAZINE) EMULSION [ELANCO US INC.]53 package rows20250206_5012fe70-6394-45f5-be75-04297e39574d.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.

Matched openFDA labels page 1 of 1 ยท 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SSD CreamSILVER SULFADIAZINEPreferred Pharmaceuticals Inc.cb7d2adf-d69d-4686-b9cf-c83d73acc4412026-08-31Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
Silver sulfadiazineSILVER SULFADIAZINEAscend Laboratories, LLCb4d6694f-2b0a-4d64-9e05-2fef6d8e60d92026-07-13Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
SSD CreamSILVER SULFADIAZINESt. Mary's Medical Park Pharmacy24b01ac4-3ed5-db3d-e063-6394a90a06292026-06-10Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINENuCare Pharmaceuticals,Inc.c6a40aee-ef43-e40b-e053-2995a90ae0482026-05-12Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEDIRECT RX7ef0cf79-e960-44a6-acac-797913b71c972026-03-17Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
Thermazene Silver SulfadiazineSILVER SULFADIAZINEPreferred Pharmaceuticals, Inc.42c3ece4-0df0-4ed8-ac0f-a65fad19eed72026-02-16Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
SILVADENESILVER SULFADIAZINEPfizer Laboratories Div Pfizer Incc437213a-1cd4-445e-a39f-bbcacb9f746f2026-01-26Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEAsclemed USA, Inc.4d9aa72e-b8dc-4ea3-be44-80f03ba819822026-01-23Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
SILVER SULFADIAZINESILVER SULFADIAZINEMylan Pharmaceuticals Inc.7a6a9590-9983-46ff-ae5c-fe95f4e16cb82025-12-26Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutions72ca5cb5-14d2-45e4-8b53-ed5809b0aeca2025-12-05Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutions067895f9-a797-4cbd-a3d2-d611d512fe5b2025-06-17Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
SSD CreamSILVER SULFADIAZINENuCare Pharmaceuticals, Inc.37670ded-5d4a-4e98-e063-6394a90a15712025-06-12Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEAdvanced Rx Pharmacy of Tennessee, LLCf1a0f489-0d9e-66c4-e053-2a95a90a063d2024-12-31Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutionsa4051ae4-f1ef-4082-920f-97d176b4cef22024-11-11Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
SSDSILVER SULFADIAZINEA-S Medication Solutionsbf1367b4-3075-4373-8998-d9006f680df32024-11-08Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEProficient Rx LP532d776e-54b3-4d4f-bb7a-94927bfba4d22024-03-01Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutions475953ba-b555-474c-9bcd-8cd314cc0d1f2024-01-31Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
SILVADENESILVER SULFADIAZINEA-S Medication Solutions54b77a36-205b-4044-9ecb-c5130f0934b52023-12-09Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEAsclemed USA, Inc.bee162c3-2627-4f28-9715-11a351d497eb2022-03-08Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
SSD CreamSILVER SULFADIAZINEDr Reddys Laboratories Inc30d6dc33-e457-466b-9159-d8e7cd7918202019-04-24Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.