NDC 85534-0023-01 - 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
- 85534-0023
- Requested NDC
- 85534-0023-01
- Package NDCs from labels
- 85534-0023-0, 85534-0023-1, 85534-0023-2, 85534-0023-3, 85534-0023-01
- 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 | Dr. Reddy's Laboratories Limited | 1ef3fe94-9bbb-934d-a09b-d19a1d23a4d5 | 2024-12-20 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen | NAPROXEN | Quality Care Products, LLC | 1acfb8cc-6faf-4b3e-9304-4819c42de0a6 | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | Hikma Pharmaceuticals USA Inc. | a5757b1a-62c9-4421-9794-6fb121ce9b7e | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naprotin | NAPROXEN , CAPSAICIN | PureTek Corporation | dc2d2783-2a73-cb7c-e053-2995a90a9961 | 2024-12-13 | Boxed warning, Warnings, Adverse reactions | 198014 |
| Naproxen | NAPROXEN | Amneal Pharmaceuticals NY LLC | 985aedc1-8b3c-4cb4-af13-7203a2b57ab7 | 2024-12-02 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen | NAPROXEN | MARKSANS PHARMA LIMITED | 1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8 | 2024-12-02 | Boxed warning, Warnings, Adverse reactions | 198014 198013 198012 57Y76R9ATQ |
| Clear Eyes Triple Relief | POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE | Prestige Brands Holdings, Inc. | 1269a1a6-843d-4d08-bb3c-c1f3d2e7080d | 2024-10-25 | Warnings | FZ989GH94E |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | da61463f-f87b-4aba-b538-7264252cadb8 | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | 198013 57Y76R9ATQ |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 1fe9a6fc-940e-4a18-b3e9-b204fd67f263 | 2024-09-03 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 205b1159-06e5-0d48-e063-6294a90acbd8 | 2024-08-23 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | a4f31070-4ee1-4d64-8b1d-40b9011e124b | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | NuCare Pharmaceuticals,Inc. | 5e873524-f9fb-fe2d-e053-2991aa0aa0a5 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen | NAPROXEN | NuCare Pharmaceuticals, Inc. | 46dd3908-6feb-4f50-e054-00144ff88e88 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | NuCare Pharmaceuticals, Inc. | 3e8bcc59-dab1-1b4c-e054-00144ff88e88 | 2024-08-13 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | 5487dee2-5c37-4348-e054-00144ff8d46c | 2024-07-17 | Warnings | 198014 57Y76R9ATQ |
| Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | NuCare Pharmaceuticals,Inc. | 9c1c4911-908e-3c3c-e053-2995a90abcfc | 2024-06-14 | Warnings | FZ989GH94E |
| NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | 71d4a048-ca50-73db-e053-2a95a90ad465 | 2024-06-10 | Warnings | 198013 57Y76R9ATQ |
| NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | 69366b55-2687-17a4-e053-2a91aa0a65b3 | 2024-06-07 | 198014 57Y76R9ATQ | |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 74134b90-d4c7-41bd-a1bd-2ac168db596f | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Clear Eyes Natural Tears | POLYVINYL ALCOHOL AND POVIDONE | Prestige Brands Holdings, Inc. | efba3eb0-798d-4635-b19b-4970e45b3cc9 | 2024-04-01 | Warnings | FZ989GH94E |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.