BONJESTA
- Product NDC
- 55494-120
- 11-digit product format
- 554940120
- Labeler code
- 55494
- Product ID
- 55494-120_3e4fbcb3-ac64-4673-b46f-a2ce616d4374
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxylamine succinate and pyridoxine hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Duchesnay USA, Inc.
- Application
- NDA209661
- Marketing category
- NDA
- Marketing start
- 2018-02-19
- Substance
- DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
- Active strength
- 20; 20 mg/1; mg/1
- Pharmacologic classes
- Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [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 |
|---|---|---|---|---|---|---|---|
| N209661-001 | BONJESTA | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N209661-001 | 9089489 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 |
| N209661-001 | 9375404 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 |
| N209661-001 | 9526703 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 |
| N209661-001 | 9937132 | 2033-02-18 | U-1382 | Drug product | 2018-04-20 |
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 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2016-11-07 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2016-11-07 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2016-11-07 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2016-11-07 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N209661-001 | BONJESTA | 20MG;20MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2016-11-07 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209661-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N209661-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N209661-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-09-29 23:25 UTC | 2022-09 | N209661-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N209661-001 | AB | 1 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N209661-001 | 9089489 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N209661-001 | 9375404 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N209661-001 | 9526703 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N209661-001 | 9937132 | 2033-02-18 | U-1382 | Drug product | 2018-04-20 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N209661-001 | 9089489 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209661-001 | 9375404 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209661-001 | 9526703 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209661-001 | 9937132 | 2033-02-18 | U-1382 | Drug product | 2018-04-20 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209661-001 | 9089489 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209661-001 | 9375404 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209661-001 | 9526703 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209661-001 | 9937132 | 2033-02-18 | U-1382 | Drug product | 2018-04-20 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N209661-001 | 9089489 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N209661-001 | 9375404 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N209661-001 | 9526703 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N209661-001 | 9937132 | 2033-02-18 | U-1382 | Drug product | 2018-04-20 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209661-001 | 9089489 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209661-001 | 9375404 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209661-001 | 9526703 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209661-001 | 9937132 | 2033-02-18 | U-1382 | Drug product | 2018-04-20 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209661-001 | 9089489 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209661-001 | 9375404 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209661-001 | 9526703 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209661-001 | 9937132 | 2033-02-18 | U-1382 | Drug product | 2018-04-20 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209661-001 | 9089489 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209661-001 | 9375404 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209661-001 | 9526703 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209661-001 | 9937132 | 2033-02-18 | U-1382 | Drug product | 2018-04-20 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209661-001 | 9089489 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209661-001 | 9375404 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209661-001 | 9526703 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209661-001 | 9937132 | 2033-02-18 | U-1382 | Drug product | 2018-04-20 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209661-001 | 9089489 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209661-001 | 9375404 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209661-001 | 9526703 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209661-001 | 9937132 | 2033-02-18 | U-1382 | Drug product | 2018-04-20 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209661-001 | 9089489 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209661-001 | 9375404 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209661-001 | 9526703 | 2033-02-18 | U-1382 | Drug product | 2017-03-03 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209661-001 | 9937132 | 2033-02-18 | U-1382 | Drug product | 2018-04-20 | d8e5a09893c0… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BONJESTA
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOXYLAMINE SUCCINATE | 20 mg/1 |
| PYRIDOXINE HYDROCHLORIDE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V9BI9B5YI2 | Internal UNII lookup |
| 68Y4CF58BV | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| dba60bb4-54ff-4e06-b8d2-acbbd3717666 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55494-120-10 | BONJESTA | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 13 | |
| 55494-120-60 | BONJESTA | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 13 | |
| 55494-120-94 | BONJESTA | 4 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 4 | 13 | |
| 55494-120-94 | BONJESTA | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | 13 | |
| 55494-120-99 | BONJESTA | 6 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 6 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55494-120-60 | EA - Each | 55494-120 | d8a4e26f-4af1-4541-9228-c09496a1284d | 1 | 2018-03-08 |
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 |
|---|---|---|---|---|---|---|
| BONJESTA | DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | Duchesnay USA, Inc. | dba60bb4-54ff-4e06-b8d2-acbbd3717666 | 2025-02-25 | Warnings, Adverse reactions | 209661 NDA209661 55494-120 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1999657 | Bonjesta 20 MG / 20 MG 12HR Extended Release Oral Tablet | PSN | dba60bb4-54ff-4e06-b8d2-acbbd3717666 | 13 |
| 1999651 | doxylamine succinate 20 MG / pyridoxine HCl 12HR 20 MG Extended Release Oral Tablet | PSN | dba60bb4-54ff-4e06-b8d2-acbbd3717666 | 13 |
| 1999657 | 12 HR doxylamine succinate 20 MG / pyridoxine hydrochloride 20 MG Extended Release Oral Tablet [Bonjesta] | SBD | dba60bb4-54ff-4e06-b8d2-acbbd3717666 | 13 |
| 1999651 | 12 HR doxylamine succinate 20 MG / pyridoxine hydrochloride 20 MG Extended Release Oral Tablet | SCD | dba60bb4-54ff-4e06-b8d2-acbbd3717666 | 13 |
| 1999651 | 12 HR doxylamine succinate 20 MG / vit-B6 Hydrochloride 20 MG Extended Release Oral Tablet | SY | dba60bb4-54ff-4e06-b8d2-acbbd3717666 | 13 |
| 1999657 | 12 HR doxylamine succinate 20 MG / vit-B6 Hydrochloride 20 MG Extended Release Oral Tablet [Bonjesta] | SY | dba60bb4-54ff-4e06-b8d2-acbbd3717666 | 13 |
| 1999651 | 12 HR doxylamine succinate 20 MG / vitamin B6 Hydrochloride 20 MG Extended Release Oral Tablet | SY | dba60bb4-54ff-4e06-b8d2-acbbd3717666 | 13 |
| 1999657 | 12 HR doxylamine succinate 20 MG / vitamin B6 Hydrochloride 20 MG Extended Release Oral Tablet [Bonjesta] | SY | dba60bb4-54ff-4e06-b8d2-acbbd3717666 | 13 |
| 1999657 | Bonjesta 20 MG / 20 MG 12HR Extended Release Oral Tablet | SY | dba60bb4-54ff-4e06-b8d2-acbbd3717666 | 13 |
| 1999651 | doxylamine succinate 20 MG / pyridoxine hydrochloride 12 HR 20 MG Extended Release Oral Tablet | SY | dba60bb4-54ff-4e06-b8d2-acbbd3717666 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55494-120-10 | 55494012010 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10) | 2018-02-19 | 0000-00-00 | No | No | Current | |
| 55494-120-60 | 55494012060 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-60) | 2018-02-19 | 0000-00-00 | No | No | Current | |
| 55494-120-94 | 55494012094 | 1 BLISTER PACK in 1 CARTON (55494-120-94) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2025-02-26 | Yes | No | Current | |
| 55494-120-99 | 55494012099 | 6 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-99) | 2018-02-19 | 0000-00-00 | Yes | No | Current |