NDC 58177-092 - Benzonatate
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
- 58177-092
- Package NDCs from labels
- 58177-092-04
- Manufacturer
- ETHEX Corporation
- Effective date
- 2008-12-30
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Benzonatate - ETHEX Corporation | ETHEX Corporation | 2008-12-30 | HUMAN PRESCRIPTION DRUG LABELING |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58177-092-04 | Benzonatate | 100 in 1 BOTTLE | CAPSULE | 100 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Benzonatate | ACTIVE INGREDIENT | 5P4DHS6ENR | BENZONATATE CAPSULE [ETHEX CORPORATION] | 1 | |
| Benzonatate | ACTIVE MOIETY | 5P4DHS6ENR | BENZONATATE CAPSULE [ETHEX CORPORATION] | 1 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | BENZONATATE CAPSULE [ETHEX CORPORATION] | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | BENZONATATE CAPSULE [ETHEX CORPORATION] | 1 | |
| methyl/propyl paraben blend | INACTIVE INGREDIENT | BENZONATATE CAPSULE [ETHEX CORPORATION] | 1 | ||
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | BENZONATATE CAPSULE [ETHEX CORPORATION] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | BENZONATATE CAPSULE [ETHEX CORPORATION] | 1 |
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 |
|---|---|---|---|---|---|---|
| Benzonatate | BENZONATATE | Precision Dose, Inc. | 978d0c83-bc01-49b2-a08a-61d72ee58ff8 | 2023-12-01 | Warnings, Adverse reactions | 197397 283417 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 6c5f67b0-3788-44e7-8dce-bcd58883d4a0 | 2023-11-14 | Warnings, Adverse reactions | 283417 |
| Benzonatate | BENZONATATE | A-S Medication Solutions | 36c3f916-cc4e-4e09-8419-4d6b64157e32 | 2023-11-11 | Warnings, Adverse reactions | 197397 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | ae3099cd-a88e-4273-bf7f-b68419d03b3e | 2023-10-24 | Warnings, Adverse reactions | 283417 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 281b849d-c380-474c-94b1-1f3778504943 | 2023-08-29 | Warnings, Adverse reactions | 197397 |
| Benzonatate | BENZONATATE | Chartwell RX, LLC | 8a17033c-1ad3-4c7a-92ee-f55756833986 | 2023-04-03 | Warnings, Adverse reactions | 197397 283417 |
| BENZONATATE | BENZONATATE | Bryant Ranch Prepack | 418c4c4e-6195-4d0d-a559-ee3f10147b5b | 2023-03-24 | Boxed warning, Adverse reactions | 283417 |
| Benzonatate | BENZONATATE | Aphena Pharma Solutions - Tennessee, LLC | 3bd33aec-9a30-4581-bd28-6cfb67772cef | 2023-03-15 | Warnings, Adverse reactions | 197397 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 1d5450e9-85bb-471e-b6f3-c2ec7a34f128 | 2023-02-24 | Warnings, Adverse reactions | 283417 |
| Benzonatate | BENZONATATE | Proficient Rx LP | 3296f664-8de0-4ccc-8346-ed2b1b0db027 | 2022-10-01 | Warnings, Adverse reactions | 283417 |
| Benzonatate | BENZONATATE | Proficient Rx LP | 47560d98-f4c4-4738-85fe-41cbed09ed59 | 2022-09-01 | Warnings, Adverse reactions | 197397 |
| Benzonatate | BENZONATATE | Proficient Rx LP | 8dcaeabf-e7da-4e0c-b6db-0bd425d6506e | 2022-07-01 | Warnings, Adverse reactions | 283417 |
| Benzonatate | BENZONATATE | TAGI Pharma, Inc. | 89c9ff5e-8929-4e63-bc11-459aa9ce7110 | 2022-06-20 | Warnings, Adverse reactions | 197397 283417 |
| Benzonatate | BENZONATATE | Proficient Rx LP | 45d9b32a-3198-49d5-addf-f077fec50b9c | 2022-06-01 | Warnings, Adverse reactions | 197397 |
| Benzonatate | BENZONATATE | Proficient Rx LP | bc435603-ddc4-4083-af09-2e562defbe7f | 2022-05-02 | Warnings, Adverse reactions | 283417 |
| Benzonatate | BENZONATATE | Proficient Rx LP | 46b4f05c-9261-42fc-a016-c99eebab5646 | 2022-05-02 | Warnings, Adverse reactions | 197397 |
| benzonatate | BENZONATATE | Proficient Rx LP | 9566b9b9-54ef-423c-8ce4-0f1714052158 | 2022-05-01 | Warnings, Adverse reactions | 197397 283417 |
| Benzonatate | BENZONATATE | Proficient Rx LP | f4337699-3279-4c08-94f4-caba6d866f63 | 2022-03-01 | Warnings, Adverse reactions | 283417 |
| Benzonatate | BENZONATATE | Proficient Rx LP | 19f1e761-69e9-4330-ad3c-1f1180d70cb0 | 2021-01-01 | Boxed warning, Adverse reactions | 197397 |
| benzonatate | BENZONATATE | Proficient Rx LP | 9fb78c06-e527-4596-884c-fcf882927a33 | 2020-02-01 | Warnings, Adverse reactions | 197397 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.