Application 011210
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TESSALON | BENZONATATE | CAPSULE;ORAL | 100MG | Yes | No |
| 003 | TESSALON | BENZONATATE | CAPSULE;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N011210-001 | TESSALON | BENZONATATE | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | |
| N011210-003 | TESSALON | BENZONATATE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N011210-001 | AA |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N011210-003 | TESSALON | 200MG | CAPSULE / ORAL | RLD | 1999-06-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N011210-003 | TESSALON | 200MG | CAPSULE / ORAL | RLD | 1999-06-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N011210-001 | TESSALON | 100MG | CAPSULE / ORAL | AA | RLD, Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N011210-003 | TESSALON | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 1999-06-25 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N011210-001 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N011210-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N011210-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011210-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N011210-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011210-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011210-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011210-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011210-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011210-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011210-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N011210-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011210-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011210-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011210-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N011210-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011210-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N011210-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N011210-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N011210-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N011210-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N011210-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N011210-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N011210-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N011210-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N011210-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N011210-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N011210-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N011210-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N011210-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N011210-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N011210-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N011210-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N011210-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N011210-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N011210-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N011210-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N011210-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N011210-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N011210-001 | AA | 1 | f41ea6bd6efb… |
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 | Northwind Health Company, LLC | da6bcd14-2294-e7df-e053-2995a90a4526 | 2026-01-01 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Northwind Health Company, LLC | da6cead3-2859-df03-e053-2a95a90a010b | 2026-01-01 | Warnings, Adverse reactions | BENZONATATE |
| BENZONATATE | BENZONATATE | Northwind Health Company, LLC | da807eb3-349e-61b9-e053-2995a90a0e21 | 2026-01-01 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Redpharm Drug | 46e97547-23d9-114a-e063-6394a90a920b | 2025-12-27 | Warnings, Adverse reactions | BENZONATATE |
| BENZONATATE | BENZONATATE | QPharma, Inc. | 55c4ae18-3e37-4caf-9fdb-9d307970b5f9 | 2025-12-21 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Redpharm Drug | 32524a8a-4cee-26c0-e063-6294a90aa898 | 2025-12-18 | Warnings, Adverse reactions | BENZONATATE |
| BENZONATATE | BENZONATATE | Coupler LLC | 463d5cff-3cd6-58fc-e063-6394a90a996b | 2025-12-18 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | QPharma Inc | fbd07fb0-c49c-a838-e053-6394a90a5f0e | 2025-12-03 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Redpharm Drug | 44f2826e-20ff-b53c-e063-6394a90a9630 | 2025-12-02 | Warnings, Adverse reactions | BENZONATATE |
| BENZONATATE | BENZONATATE | Ascend Laboratories, LLC | 54374c04-63b9-49fa-b6a2-4a711e322d8e | 2025-12-02 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | A-S Medication Solutions | 1b5364d2-bbd5-4c05-a7b5-a5cdbf1d37e9 | 2025-12-01 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | a8d13a2b-b7cf-4c33-ad2f-fda5c7e598b9 | 2025-10-28 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 751d9d60-cd6b-4aa1-b68f-61b86c4059ad | 2025-08-26 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | a52856fc-049d-48cf-8cc4-de059850e31a | 2025-06-26 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 995ebc53-4e13-4c1d-b301-71ac83c6def8 | 2025-06-04 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Asclemed USA, Inc. | 25ed5206-b322-486f-9e54-14125f6e74c5 | 2025-04-18 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | RedPharm Drug, Inc. | a2f6acff-70ff-79f1-e053-2a95a90a6005 | 2025-04-09 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | RedPharm Drug, Inc. | f3c2acfc-f598-50ab-e053-2a95a90a11e7 | 2025-04-09 | Warnings, Adverse reactions | BENZONATATE |
| BENZONATATE | BENZONATATE | DIRECT RX | 673bf826-a005-7a38-e053-2991aa0a4cb5 | 2025-02-17 | Warnings, Adverse reactions | BENZONATATE |
| Benzonatate | BENZONATATE | Coupler LLC | 2ce035ff-42cb-d8ef-e063-6294a90a0c06 | 2025-01-29 | Warnings, Adverse reactions | BENZONATATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-0122 | Tessalon | benzonatate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0122 | Tessalon | benzonatate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0122 | Tessalon | benzonatate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0122 | Tessalon | benzonatate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 59762-1122 | Benzonatate | benzonatate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1122 | Benzonatate | benzonatate | Greenstone LLC | NDA | Current |
| 59762-1122 | Benzonatate | benzonatate | Greenstone LLC | NDA | Current |