Benzonatate
- Product NDC
- 70518-3542
- 11-digit product format
- 705183542
- Labeler code
- 70518
- Product ID
- 70518-3542_e9d445dd-9986-475a-e053-2a95a90a46ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA202765
- Marketing category
- ANDA
- Marketing start
- 2022-09-29
- Marketing end
- 0000-00-00
- Substance
- BENZONATATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70518-3542 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 70518-3542 | 70518-3542-0 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 70518-3542 | 70518-3542-1 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 70518-3542 | 70518-3542-2 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 70518-3542 | 70518-3542-3 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 70518-3542 | 70518-3542-4 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 70518-3542-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 70518-3542-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 70518-3542-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 70518-3542-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 70518-3542-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 70518-3542-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 70518-3542-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 70518-3542-2 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202765-001 | BENZONATATE | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | |
| A202765-002 | BENZONATATE | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202765-001 | AA |
| A202765-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202765-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2015-07-31 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202765-002 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2017-08-25 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202765-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202765-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202765-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202765-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202765-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202765-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202765-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202765-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202765-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202765-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202765-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202765-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202765-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202765-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202765-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202765-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202765-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202765-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202765-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202765-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202765-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202765-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202765-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202765-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202765-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202765-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202765-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A202765-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202765-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202765-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A202765-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A202765-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A202765-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202765-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A202765-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202765-002 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A202765-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202765-002 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A202765-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202765-002 | AA | 1 | 782e0a99824c… |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-3542 | BENZONATATE CAPSULE [REMEDYREPACK INC.] | 6 | Legacy NDC | 20240326_8d3beb37-03e4-42a4-b701-e881d734d95b.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 |
|---|---|---|---|---|---|---|
| Benzonatate | BENZONATATE | St. Mary's Medical Park Pharmacy | 3f686042-02bc-8a78-e063-6294a90a7f56 | 2026-07-17 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | e1bf84c8-fc88-4f43-8655-7ce95a4da51f | 2026-02-06 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | REMEDYREPACK INC. | 07018b47-76f5-49d3-b7d3-081f82d382b2 | 2026-02-02 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | Redpharm Drug | 44f2826e-20ff-b53c-e063-6394a90a9630 | 2025-12-02 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | a8d13a2b-b7cf-4c33-ad2f-fda5c7e598b9 | 2025-10-28 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | REMEDYREPACK INC. | 284a8cbb-632b-41ba-97b8-07fe70c14a83 | 2025-10-16 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | a52856fc-049d-48cf-8cc4-de059850e31a | 2025-06-26 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 5008eb9e-b209-4393-8d13-bb92976e8dde | 2024-08-20 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | Rising Pharma Holdings, Inc. | 0ca22f92-9750-4eb4-8cdb-ebd3b12691cc | 2024-06-07 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 5add9fd2-5f54-4669-b82a-0e0a8fcd5a8f | 2024-05-23 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 77b51a56-43e8-4be0-b993-28b1cecdbf14 | 2024-03-15 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | A-S Medication Solutions | cf41278a-3fb6-4bcb-b86e-016a41314625 | 2024-01-29 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 9083ff4d-dd50-4931-b14f-cfa08fccba8b | 2024-01-12 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 2471d5d9-ea9e-482a-811d-ad173b253be7 | 2024-01-10 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | Precision Dose, Inc. | 978d0c83-bc01-49b2-a08a-61d72ee58ff8 | 2023-12-01 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 6c5f67b0-3788-44e7-8dce-bcd58883d4a0 | 2023-11-14 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | A-S Medication Solutions | 36c3f916-cc4e-4e09-8419-4d6b64157e32 | 2023-11-11 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | ae3099cd-a88e-4273-bf7f-b68419d03b3e | 2023-10-24 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 281b849d-c380-474c-94b1-1f3778504943 | 2023-08-29 | Warnings, Adverse reactions | 202765 ANDA202765 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 1d5450e9-85bb-471e-b6f3-c2ec7a34f128 | 2023-02-24 | Warnings, Adverse reactions | 202765 ANDA202765 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-3542-0 | 70518354200 | 30 CAPSULE in 1 BLISTER PACK (70518-3542-0) | 30 capsule | 2022-09-29 | 0000-00-00 | No | No | Current |