NDC 85534-0058-01 - Naproxen
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 85534-0058
- Requested NDC
- 85534-0058-01
- Package NDCs from labels
- 85534-0058-0, 85534-0058-1, 85534-0058-2, 85534-0058-3, 85534-0058-01
- Manufacturer
- HAWAII REPACK, INC.
- Effective date
- 2026-06-26
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Naproxen - HAWAII REPACK, INC. | HAWAII REPACK, INC. | 2026-06-26 | HUMAN PRESCRIPTION DRUG LABEL |
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 |
|---|---|---|---|---|---|---|
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Proficient Rx LP | 5fd008ef-8388-48e9-8d38-76e0106bd5b6 | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen | NAPROXEN | Radha Pharmaceuticals, Inc. | 1a2b9a82-5b79-45ee-94ed-7a6f8c8b5170 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198014 198013 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | AvPAK | e6fbf8f1-b064-658d-17bb-e7d6320aa45f | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | 198014 198013 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | ScieGen Pharmaceuticals, Inc. | 81e22c1f-f94d-46e9-8b7d-72dc2518319e | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | ANDA212517 50228-435 50228-434 50228-436 198014 198013 198012 9af8c9f3-92e7-4301-b401-f40230af2eb7 81e22c1f-f94d-46e9-8b7d-72dc2518319e 57Y76R9ATQ |
| Naproxen | NAPROXEN | NuCare Pharmaceuticals,Inc. | c136cf75-4ad4-8634-e053-2a95a90a53a4 | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198014 57Y76R9ATQ |
| Leader Advanced Relief Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Cardinal Health | 5c5d6c13-9b51-48f0-8627-b60b0f707fd3 | 2026-03-12 | Warnings | FZ989GH94E |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | PHOENIX RX LLC | 4c25c106-b5ca-079f-e063-6394a90a4978 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen | NAPROXEN | Aurobindo Pharma Limited | 67815abd-5e97-4ccb-ac9b-28c2ef6123e7 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| GoodSense Eye Drops Advanced Relief Moisturizer | DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Sportpharm LLC | 8d58dcbb-72a0-41f0-9eeb-613072a6d7ae | 2026-02-06 | Warnings | FZ989GH94E |
| MINIDROPS | LUBRICANT EYE DROPS | Optics Laboratory, Inc | c13c5f91-50df-471c-a7c9-1747a2ac1250 | 2026-02-03 | Warnings | FZ989GH94E |
| Naproxen | NAPROXEN | A-S Medication Solutions | 4e97e645-552d-424b-990a-f94349a86f17 | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | A-S Medication Solutions | 000155a8-709c-44e5-a75f-cd890f3a7caf | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | A-S Medication Solutions | d06db628-f6f0-48e2-b538-69c0837c49e3 | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | 198014 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | A-S Medication Solutions | 9d28422f-6f25-4f14-9272-e0907c971f33 | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | 198014 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | Preferred Pharmaceuticals Inc. | 87acd650-ea8a-4396-be72-5568c4b1755c | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Preferred Pharmaceuticals Inc. | b295a90e-320f-4414-b80a-d11f06c00c96 | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen | NAPROXEN | Acella Pharmaceuticals, LLC | 7e6f03fb-4b36-4418-9684-f45637abbb78 | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | fa2fe6fd-c476-dd29-e053-6294a90a9e9e | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | Northwind Health Company, LLC | 0de6d673-fa76-e9c0-e063-6394a90a9ded | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 198012 57Y76R9ATQ |
| NAPROXEN | NAPROXEN | Northwind Health Company, LLC | f32d755e-4984-ee40-e053-2995a90a4ebe | 2026-01-01 | Warnings | 198014 57Y76R9ATQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.