Application 076518
- Type
- ANDA
- Sponsor
- PERRIGO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 220MG;120MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 |
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 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG BASE;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG BASE;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Mucinex DS 12HR COLD, FEVER and SINUS | NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 4e7e6674-c1ce-ea61-e063-6294a90afe04 | 2026-05-12 | Warnings | 076518 ANDA076518 |
| Aleve-D Sinus and Headache | NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5ab980c0-c48a-233b-e053-2991aa0a4fd1 | 2025-12-04 | Warnings | 076518 ANDA076518 0280-6045 |
| Aleve-D Sinus and Cold | NAPROXEN SODIUM, PSEUDEOEPHEDRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 599ea6c8-03ad-536e-e053-2991aa0a83a3 | 2025-12-04 | Warnings | 076518 ANDA076518 0280-6090 |
| Leader All Day Sinus and Cold D | NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL | Cardinal Health 110, LLC. dba Leader | 83f7cfbb-ab84-4594-ae7a-4a657385c8a7 | 2025-04-25 | Warnings | 076518 ANDA076518 70000-0605 |
| All Day Sinus and Cold D | NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL | Walgreen Company | b0417ce5-3a5e-42cb-8672-9f2b133c91ca | 2025-04-25 | Warnings | 076518 ANDA076518 0363-0650 |
| Sinus and Cold D | NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL | Meijer Distribution Inc | cb78330b-d8a3-4c16-bbb0-d31368a542e6 | 2025-04-18 | Warnings | 076518 ANDA076518 41250-417 |
| Topcare Sinus and Cold D | NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL | Topco Associates LLC | 55c177ce-1729-4a9b-a5ae-2b6c96fbc27a | 2025-04-17 | Warnings | 076518 ANDA076518 36800-417 |
| Sudafed Sinus 12 Hour Pressure plus Pain | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | 305adca3-cdae-41e5-a10a-99d9dd0fe390 | 2024-11-08 | Warnings | 076518 ANDA076518 50580-434 |
| Sinus and Cold D | NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 9e142ac7-c8b1-449b-a224-c7db0fc0e4cf | 2024-07-10 | Warnings | 076518 ANDA076518 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0113-2417 | sinus and cold d | Naproxen sodium, Pseudoephedrine HCl | L. Perrigo Company | ANDA | Current |
| 0113-2417 | sinus and cold d | Naproxen sodium, Pseudoephedrine HCl | L. Perrigo Company | ANDA | Current |
| 0280-6045 | Aleve-D Sinus and Headache | naproxen sodium, pseudoephedrine hydrochloride | Bayer HealthCare LLC. | ANDA | Current |
| 0280-6045 | Aleve-D Sinus and Headache | naproxen sodium, pseudoephedrine hydrochloride | Bayer HealthCare LLC. | ANDA | Current |
| 0280-6045 | Aleve-D Sinus and Headache | naproxen sodium, pseudoephedrine hydrochloride | Bayer HealthCare LLC. | ANDA | Current |
| 0280-6045 | Aleve-D Sinus and Headache | naproxen sodium, pseudoephedrine hydrochloride | Bayer HealthCare LLC. | ANDA | Current |
| 0280-6045 | Aleve-D Sinus and Headache | naproxen sodium, pseudoephedrine hydrochloride | Bayer HealthCare LLC. | ANDA | Current |
| 0280-6090 | Aleve-D Sinus and Cold | naproxen sodium, pseudeoephedrine hydrochloride | Bayer HealthCare LLC. | ANDA | Current |
| 0280-6090 | Aleve-D Sinus and Cold | naproxen sodium, pseudeoephedrine hydrochloride | Bayer HealthCare LLC. | ANDA | Current |
| 0280-6090 | Aleve-D Sinus and Cold | naproxen sodium, pseudeoephedrine hydrochloride | Bayer HealthCare LLC. | ANDA | Current |
| 0280-6090 | Aleve-D Sinus and Cold | naproxen sodium, pseudeoephedrine hydrochloride | Bayer HealthCare LLC. | ANDA | Current |
| 0280-6090 | Aleve-D Sinus and Cold | naproxen sodium, pseudeoephedrine hydrochloride | Bayer HealthCare LLC. | ANDA | Current |
| 0363-0650 | All Day Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Walgreen Company | ANDA | Current |
| 0363-0650 | All Day Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Walgreen Company | ANDA | Current |
| 11673-417 | Up and Up Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Target Corporation | ANDA | Current |
| 11673-417 | Up and Up Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Target Corporation | ANDA | Current |
| 36800-417 | Topcare Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Topco Associates LLC | ANDA | Current |
| 36800-417 | Topcare Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Topco Associates LLC | ANDA | Current |
| 36800-417 | Topcare Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Topco Associates LLC | ANDA | Current |
| 37000-921 | Vicks Sinex D | Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, and Dextromethorphan Hydrobromide | The Procter & Gamble Manufacturing Company | ANDA | Current |
| 37000-921 | Vicks Sinex D | Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, and Dextromethorphan Hydrobromide | The Procter & Gamble Manufacturing Company | ANDA | Current |
| 41250-417 | Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Meijer Distribution Inc | ANDA | Current |
| 41250-417 | Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Meijer Distribution Inc | ANDA | Current |
| 46122-197 | Good Neighbor Pharmacy Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Amerisource Bergen | ANDA | Current |
| 49035-792 | equate sinus and cold d | naproxen sodium, pseudoephedrine hydrochloride | Wal-Mart Stores Inc | ANDA | Current |
| 49035-792 | equate sinus and cold d | naproxen sodium, pseudoephedrine hydrochloride | Wal-Mart Stores Inc | ANDA | Current |
| 49035-792 | equate sinus and cold d | naproxen sodium, pseudoephedrine hydrochloride | Wal-Mart Stores Inc | ANDA | Current |
| 49348-393 | Sunmark Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 49348-393 | Sunmark Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | McKesson | ANDA | Current |
| 49348-393 | Sunmark Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 49348-393 | Sunmark Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 50580-434 | Sudafed Sinus 12 Hour Pressure plus Pain | Naproxen sodium and Pseudoephedrine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | ANDA | Current |
| 50580-434 | Sudafed Sinus 12 Hour Pressure plus Pain | Naproxen sodium and Pseudoephedrine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | ANDA | Current |
| 50580-539 | Sudafed | Naproxen sodium and Pseudoephedrine Hydrochloride | Johnson & Johnson Consume | ANDA | Current |
| 59779-417 | Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | CVS Pharmacy | ANDA | Current |
| 59779-417 | Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | CVS Pharmacy | ANDA | Current |
| 62011-0204 | Health Mart Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | McKesson | ANDA | Current |
| 62011-0204 | Health Mart Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0204 | Health Mart Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 70000-0281 | Leader Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Cardinal Health | ANDA | Current |
| 70000-0281 | Leader Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Cardinal Health | ANDA | Current |
| 70000-0605 | Leader All Day Sinus and Cold D | Naproxen sodium, Pseudoephedrine HCl | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31135 | ORIG | 2004-03-19 |