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 |
|---|---|---|---|---|---|---|
| Harris Teeter Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | Harris Teeter, LLC | f76e2831-5c6c-7a62-e053-6294a90a937b | 2025-12-30 | Warnings | FZ989GH94E |
| CareOne Artificial Tears Eye Drops 15mL | POLYVINYL ALCOHOL, POVIDONE | Retail Business Services, LLC | 92fded6b-91fd-d82e-e053-2a95a90ab523 | 2025-12-30 | Warnings | FZ989GH94E |
| Quality Choice Artificial Tears Lubricant Eye Drops | POLYVINYL ALCOHOL, POVIDONE | Chain Drug Marketing Association, Inc. | 1f669655-4bc7-0175-e063-6294a90a305a | 2025-12-30 | Warnings | FZ989GH94E |
| Equate Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | Walmart, Inc. | ead9f271-0f15-1fff-e053-2a95a90a93ac | 2025-12-30 | Warnings | FZ989GH94E |
| Eye Love Heyedrate Long Lasting Hydration | GLYCERIN, POVIDONE | Physician Recommended Neutraceuticals, L.P. | f321dea1-3251-eaa8-e053-2995a90aaf95 | 2025-12-30 | Warnings | FZ989GH94E |
| Quality Choice Moisturizing Relief Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Chain Drug Marketing Association, Inc. | 1fb81759-5931-59c8-e063-6294a90a2277 | 2025-12-30 | Warnings | FZ989GH94E |
| Naproxen | NAPROXEN | QPharma, Inc. | 307aa67f-53b9-4c60-a328-091bbf6338d4 | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen Sodium | NAPROXEN SODIUM | Glenmark Pharmaceuticals Inc., USA | 6c5bb008-e66f-4ef0-bf84-aca7eb5983e9 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | 198014 198013 198012 57Y76R9ATQ |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Ajanta Pharma USA Inc. | 7ca657dc-4376-4693-8568-99351fac8186 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen | NAPROXEN | Sunrise Pharmaceutical, Inc. | f2fb222a-b854-4e6f-9027-2e08aed24185 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| NAPROXEN | NAPROXEN | QPharma Inc | c0a4839b-7154-c82c-e053-2a95a90a7e6d | 2025-12-03 | Warnings | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | PHOENIX RX LLC | 43912294-77c9-eda8-e063-6394a90adf0a | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | A-S Medication Solutions | 8c3398bd-66b1-4a14-8aaa-e4a2d6749a08 | 2025-11-02 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | Medcore LLC | 129392c8-8ce1-4b78-8863-042db880095f | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198014 57Y76R9ATQ |
| LACRIFRESH HYDRAPF | GLYCERIN, POVIDONE | AVIZOR, S.A. | 41bbd23e-0ec8-eb18-e063-6294a90a46d1 | 2025-10-27 | Warnings | FZ989GH94E |
| LACRIFRESH HYDRAMAXPF | GLYCERIN, POVIDONE | AVIZOR, S.A. | 41be1604-89b4-7ec3-e063-6294a90a3331 | 2025-10-27 | Warnings | FZ989GH94E |
| Stye | POLYVINYL ALCOHOL AND POVIDONE | Medtech Products Inc. | 60c11d3d-df20-4d1c-b425-49a84fecea30 | 2025-10-23 | Warnings | FZ989GH94E |
| iVIZIA Dry Eye | POVIDONE | Thea Pharma Inc. | 1ef73cb1-da48-a713-e063-6294a90afa9d | 2025-10-20 | Warnings | FZ989GH94E |
| NAPROXEN | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | a9f9ce81-9d51-4167-9581-974866a8fe31 | 2025-10-17 | Warnings | 198014 57Y76R9ATQ |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Preferred Pharmaceuticals Inc. | 6368a3be-4b79-466b-8ec4-11fc3ac623cc | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.