NDC 58198-0075-2 - Comfortis
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
- 58198-0075
- Requested NDC
- 58198-0075-2
- Package NDCs from labels
- 58198-0075-1, 58198-0075-2
- Manufacturer
- Elanco US Inc.
- Effective date
- 2024-11-06
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Comfortis ™ (spinosad) | Elanco US Inc. | 2024-11-06 | PRESCRIPTION ANIMAL DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58198-0075-1 | Comfortis | 10 in 1 BOX | TABLET, CHEWABLE | 10 | 2 | |
| 58198-0075-1 | Comfortis | 1 in 1 CARTON | TABLET, CHEWABLE | 1 | 2 | |
| 58198-0075-2 | Comfortis | 6 in 1 BLISTER PACK | TABLET, CHEWABLE | 6 | 2 | |
| 58198-0075-2 | Comfortis | 1 in 1 CARTON | TABLET, CHEWABLE | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58198-0075 | COMFORTIS (SPINOSAD) TABLET, CHEWABLE [ELANCO US INC.] | 2 | 4 package rows | 20241127_d3489ebc-9900-4377-9a8b-98ae7c38ebd2.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 |
|---|---|---|---|---|---|---|
| Spinosad | SPINOSAD | Cipher Pharmaceuticals Inc. | 16a95039-0df7-45d5-8b51-bbc81443fea3 | 2026-03-04 | Warnings, Adverse reactions | XPA88EAP6V |
| Natroba | SPINOSAD | Cipher Pharmaceuticals Inc. | 72cf38f4-9ef4-4b0e-b085-b02f399e2592 | 2026-03-04 | Warnings, Adverse reactions | XPA88EAP6V |
| Spinosad | SPINOSAD | Allegis Pharmaceuticals, LLC | 8e87bd3b-db25-4e97-bf57-96c875f67ce1 | 2025-12-17 | Warnings, Adverse reactions | XPA88EAP6V |
| Spinosad | SPINOSAD | ParaPRO LLC | 0d6e2507-3669-441e-b5ba-86087fd2955d | 2024-01-29 | Warnings, Adverse reactions | XPA88EAP6V |
| Natroba | SPINOSAD | ParaPRO LLC | fa90ccc8-2df0-49f7-8878-2b33e34cd272 | 2021-04-28 | Warnings, Adverse reactions | XPA88EAP6V |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.