NDC 53401-034-80 - HYDROXYZINE HYDROCHLORIDE
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
- 53401-034
- Requested NDC
- 53401-034-80
- Package NDCs from labels
- 53401-034-53, 53401-034-60, 53401-034-70, 53401-034-80
- Manufacturer
- Aphena Pharma Solutions - Tennessee, LLC
- Effective date
- 2026-09-16
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE - Aphena Pharma Solutions - Tennessee, LLC | Aphena Pharma Solutions - Tennessee, LLC | 2026-09-16 | 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 |
|---|---|---|---|---|---|---|
| PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5 | ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE | Longway Technology(Guangzhou) Co., Ltd. | 3ceb3368-439c-9f6c-e063-6294a90a98ba | 2025-08-21 | Warnings | 15FIX9V2JP |
| PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2 | ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDE | Longway Technology(Guangzhou) Co., Ltd. | 3cc8b151-c07d-7473-e063-6294a90a1cc7 | 2025-08-20 | Warnings | 15FIX9V2JP |
| SEYE | ZINC OXIDE AND TITANIUM DIOXIDE CREAM | Guangzhou Seye Biomedical Technology Co., Ltd. | 3cce91b1-311b-4c95-e063-6294a90a2d7a | 2025-08-20 | Warnings | 15FIX9V2JP |
| Aurum Hypericum | AURUM HYPERICUM | Uriel Pharmacy Inc. | 0c3ed6fe-8dce-0496-e063-6394a90add56 | 2025-08-19 | Warnings | ETJ7Z6XBU4 |
| Fungus Fighter | CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC. | Newton Laboratories, Inc. | 93e05175-001b-c639-e053-2a95a90a289c | 2025-08-19 | Warnings | ETJ7Z6XBU4 |
| Fungus Fighter | CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC. | Newton Laboratories, Inc. | 9b4276af-b738-3293-e053-2a95a90ad022 | 2025-08-19 | Warnings | ETJ7Z6XBU4 |
| Sun Bum 30 Mineral Sunscreen Face 1.7 OZ | TITANIUM DIOXIDE, ZINC OXIDE | Sun Bum, LLC | 3b1729c5-d8ca-94c7-e063-6394a90a67a5 | 2025-08-18 | Warnings | 15FIX9V2JP |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 2b05bd0e-af57-4e74-92f8-a4311330142f | 2025-08-18 | Warnings, Adverse reactions | 995258 76755771U3 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 214b3f14-2f6c-4f36-b7a6-e0b1f820e3a7 | 2025-08-18 | Warnings, Adverse reactions | 995281 76755771U3 |
| MOISTURE SURGE CC BROAD SPECTRUM SPF 30 HYDRATING COLOUR CORRECTOR | OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDE | CLINIQUE LABORATORIES LLC | ea4d564f-ac64-abac-e053-2a95a90a8abb | 2025-08-15 | Warnings | 15FIX9V2JP |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 6a1a48ac-8ad5-4363-b298-d9825ae2a448 | 2025-08-14 | Warnings, Adverse reactions | 995218 995281 995258 76755771U3 |
| Sun Bum 50 Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Sun Bum, LLC | 3a263b85-e7a0-c068-e063-6294a90a49f2 | 2025-08-14 | Warnings | 15FIX9V2JP |
| Sun Bum 50 Mineral Sunscreen Roll-On | TITANIUM DIOXIDE, ZINC OXIDE | Sun Bum, LLC | 3a392237-019d-2384-e063-6394a90a5b24 | 2025-08-14 | Warnings | 15FIX9V2JP |
| Schuessler Tissue Salts Comb D Skin Disorders | KALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEA | Martin & Pleasance Pty Ltd | 617303f8-4463-4a1e-a502-44abc181d91f | 2025-08-13 | Warnings | ETJ7Z6XBU4 |
| Schuessler Tissue Salts Comb D Skin Disorders | KALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEA | Martin & Pleasance Pty Ltd | 03153d92-dc68-4b84-a8c9-634b1ffd7da1 | 2025-08-13 | Warnings | ETJ7Z6XBU4 |
| Silk Screen | TITANIUM DIOXIDE, ZINC OXIDE | Skin Apeel, Inc. | 3c457455-b9b1-546b-e063-6294a90a41f6 | 2025-08-13 | Warnings | 15FIX9V2JP |
| Baby Bum Mineral 50 Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Sun Bum, LLC | 3c470ff8-37d6-a729-e063-6294a90aa525 | 2025-08-13 | Warnings | 15FIX9V2JP |
| 100% MINERAL SUNSCREEN | 100% MINERAL SUNSCREEN | Guangzhou Pallas Cosmetics Co.,Ltd. | 3c4a3b41-9183-3835-e063-6394a90aea61 | 2025-08-13 | Warnings | 15FIX9V2JP |
| ERBORIAN CC CREME Color Correcting SPF 25 FAIR | OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE | LABORATOIRES M&L | 4443d4e6-bdc9-4547-9189-e94e9e0bdd2d | 2025-08-12 | Warnings | 15FIX9V2JP |
| ERBORIAN CC Red Correct Color Correcting SPF 25 | OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE | LABORATOIRES M&L | a6cd16cc-5fe3-41b5-b724-83e469cd4d5e | 2025-08-12 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.