NDC 85534-0024-01 - 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
- 85534-0024
- Requested NDC
- 85534-0024-01
- Package NDCs from labels
- 85534-0024-0, 85534-0024-1, 85534-0024-2, 85534-0024-3, 85534-0024-01
- 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 | NAPROXEN | Bryant Ranch Prepack | e0f430fd-4511-41c8-b5e9-894abe4f3c37 | 2025-10-13 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | A-S Medication Solutions | cfa88511-40bb-4658-b606-44c68d0746b7 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | A-S Medication Solutions | b500bdba-946a-41ff-855c-1f2937547d01 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | Aurobindo Pharma Limited | 570974d4-0d5b-4df2-b307-37380511835d | 2025-10-07 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | 2d01e583-670a-46f4-b5f2-3fad46d0376f | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 124af155-0661-4054-9800-de547d8212d7 | 2025-09-17 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Eyes Irritation Relief | POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE | CARDINAL HEALTH 110, LLC. DBA LEADER | bd2608c6-ffdf-352a-e053-2995a90a26a8 | 2025-09-12 | Warnings | FZ989GH94E |
| Naproxen | NAPROXEN | Zameer Pharmaceuticals LLC | d2e5553a-7c90-407c-9f07-3be65560c23a | 2025-08-23 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | PHOENIX RX LLC | 3a652450-525b-4839-e063-6294a90ac287 | 2025-08-14 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Preferred Pharmaceuticals Inc | 470496f5-a71d-40b2-bf11-3a8d3d790962 | 2025-07-31 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | PHOENIX RX LLC | 3a6637ca-0c55-f648-e063-6294a90aaef7 | 2025-07-20 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | 29d98cf3-a0f2-3f89-e054-00144ff88e88 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | 6573681e-e9be-440f-a818-a533b744648e | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 198013 57Y76R9ATQ |
| Naproxen | NAPROXEN | Proficient Rx LP | e64b3b36-f96e-463e-aca8-8f6e86724bcf | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198013 57Y76R9ATQ |
| Naproxen | NAPROXEN | Aurobindo Pharma Limited | 0e5315bc-c02f-4749-be69-b5b528327d58 | 2025-06-07 | Boxed warning, Warnings, Adverse reactions | 198014 198013 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | Amneal Pharmaceuticals LLC | c43a43e2-e867-448d-8f59-3efc7c077cbc | 2025-05-28 | Boxed warning, Warnings, Adverse reactions | 198014 198013 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | A-S Medication Solutions | 7fef9311-471b-472c-b4f2-c952a2b3a255 | 2025-05-07 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | Camber Pharmaceuticals, Inc. | fd5e8d84-f92c-4f4b-ab0d-4cda7cf826bd | 2025-05-06 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen | NAPROXEN | Coupler LLC | 3375e139-d9de-8c2d-e063-6394a90a653d | 2025-04-23 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | A-S Medication Solutions | e63a034d-23ef-458f-88ed-8b6d73699621 | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | 198013 57Y76R9ATQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.