Benzonatate
- Product NDC
- 65162-536
- 11-digit product format
- 651620536
- Labeler code
- 65162
- Product ID
- 65162-536_72b0f799-3f8f-4dcf-9c6e-57e796996a80
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA040682
- Marketing category
- ANDA
- Marketing start
- 2010-06-04
- Substance
- BENZONATATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040682-001 | BENZONATATE | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | |
| A040682-002 | BENZONATATE | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040682-001 | AA |
| A040682-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040682-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-07-30 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040682-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-30 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040682-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040682-002 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040682-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040682-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040682-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040682-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040682-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040682-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040682-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040682-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040682-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040682-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040682-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040682-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040682-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040682-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040682-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040682-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040682-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040682-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040682-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040682-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040682-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040682-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040682-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040682-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040682-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040682-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040682-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040682-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040682-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040682-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040682-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040682-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040682-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040682-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040682-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040682-002 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040682-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040682-002 | AA | 1 | bb7c543d1eb4… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Benzonatate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZONATATE | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5P4DHS6ENR | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 199a42ae-4d19-4e68-934d-dabd27084988 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dc429dc2-e942-6686-8d72-b63c57e806aa | Product name | 5 | 20190416 |
| d45c2ed6-126c-dd22-afd2-e29a2ecf77b9 | Product name | 3 | 20190215 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65162-536-10 | Benzonatate | 100 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 100 | 17 | |
| 65162-536-50 | Benzonatate | 500 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 500 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65162-536-10 | EA - Each | 65162-536 | e6b6447b-edef-42fc-a471-38ef4db3be73 | 1 | 2012-07-24 |
| 65162-536-50 | EA - Each | 65162-536 | c461518f-f944-41de-b640-8ed65c6de13d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | Bryant Ranch Prepack | 0151d970-fd80-482d-ad92-03015eef2618 | 2026-08-11 | Warnings, Adverse reactions | 040682 ANDA040682 |
| Benzonatate | BENZONATATE | Redpharm Drug | 4972e1e4-7eac-a770-e063-6294a90abe28 | 2026-01-28 | Warnings, Adverse reactions | 040682 ANDA040682 |
| Benzonatate | BENZONATATE | Redpharm Drug | 46e97547-23d9-114a-e063-6394a90a920b | 2025-12-27 | Warnings, Adverse reactions | 040682 ANDA040682 |
| Benzonatate | BENZONATATE | Amneal Pharmaceuticals LLC | 199a42ae-4d19-4e68-934d-dabd27084988 | 2024-10-23 | Boxed warning, Adverse reactions | 040682 ANDA040682 65162-536 |
| Benzonatate | BENZONATATE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | f32014c7-bc0c-4edb-b591-7baa6664d74b | 2024-09-29 | Warnings, Adverse reactions | 040682 ANDA040682 |
| Benzonatate | BENZONATATE | Chartwell RX, LLC | 8a17033c-1ad3-4c7a-92ee-f55756833986 | 2023-04-03 | Warnings, Adverse reactions | 040682 ANDA040682 |
| BENZONATATE | BENZONATATE | Bryant Ranch Prepack | 418c4c4e-6195-4d0d-a559-ee3f10147b5b | 2023-03-24 | Boxed warning, Adverse reactions | 040682 ANDA040682 |
| Benzonatate | BENZONATATE | Proficient Rx LP | 19f1e761-69e9-4330-ad3c-1f1180d70cb0 | 2021-01-01 | Boxed warning, Adverse reactions | 040682 ANDA040682 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65162-536-10 | 65162053610 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-536-10) | 2010-06-04 | 0000-00-00 | No | No | Current |
| 65162-536-50 | 65162053650 | 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-536-50) | 2010-06-04 | 0000-00-00 | No | No | Current |