Benzonatate Capsules, USP
- Manufacturer
- Zydus Lifesciences Limited
- Effective date
- 2024-11-25
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 9
- Source
- full-release
- Hydrated at
- 2026-05-31 21:18:17
Label at a glance#
Label contents#
Full prescribing information#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZONATATE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
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 |
|---|---|---|---|---|---|---|
| 65841-614-01 | Benzonatate | 100 in 1 BOTTLE | CAPSULE | 100 | 9 | |
| 65841-614-05 | Benzonatate | 500 in 1 BOTTLE | CAPSULE | 500 | 9 | |
| 65841-843-01 | Benzonatate | 100 in 1 BOTTLE | CAPSULE | 100 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65841-614 | BENZONATATE CAPSULE [ZYDUS LIFESCIENCES LIMITED] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241128_abb4360a-4c52-45b6-9b80-df3c1bfc4c59.zip |
| 65841-843 | BENZONATATE CAPSULE [ZYDUS LIFESCIENCES LIMITED] | 9 | Current NDC, Legacy NDC, 1 package rows | 20241128_abb4360a-4c52-45b6-9b80-df3c1bfc4c59.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BENZONATATE | ACTIVE INGREDIENT | 5P4DHS6ENR | 2 | |
| BENZONATATE | ACTIVE MOIETY | 5P4DHS6ENR | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- Benzonatate
- GLYCERIN
- METHYLPARABEN
- PROPYLPARABEN
- SORBITOL
- WATER
- GELATIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65841-614 | 65841-614-01, 65841-614-05 |
| 65841-843 | 65841-843-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZONATATE | 5P4DHS6ENR | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SORBITOL | 506T60A25R | IACT |
| WATER | 059QF0KO0R | IACT |
| GELATIN | 2G86QN327L | IACT |
| BENZONATATE | 5P4DHS6ENR | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SORBITOL | 506T60A25R | IACT |
| WATER | 059QF0KO0R | IACT |
| GELATIN | 2G86QN327L | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / ORAL | 10932 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE / ORAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / ORAL | 10932 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / ORAL | 10932 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / ORAL | 10932 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE / ORAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE / ORAL | 1 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / ORAL | 10932 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE / ORAL | 1 mg |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040597-001 | BENZONATATE | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | |
| A040597-002 | BENZONATATE | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040597-001 | AA |
| A040597-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A040597-001 | AA | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A040597-002 | AA | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A040597-001 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A040597-002 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A040597-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040597-002 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040597-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040597-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040597-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040597-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040597-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040597-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040597-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040597-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040597-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040597-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040597-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040597-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040597-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040597-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040597-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040597-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040597-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040597-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040597-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040597-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040597-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040597-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040597-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040597-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040597-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040597-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040597-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040597-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040597-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040597-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040597-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040597-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040597-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040597-002 | AA | 1 | 4b0b4de00fa7… |
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 | Zydus Lifesciences Limited | abb4360a-4c52-45b6-9b80-df3c1bfc4c59 | 2024-11-25 | 65841-614-05 65841-843-01 65841-614-01 65841-843 65841-614 65841061401 65841084301 65841061405 fb123061-e971-4394-aa10-ae733de31be1 abb4360a-4c52-45b6-9b80-df3c1bfc4c59 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

