NDC 53401-034 - 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
- 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 |
|---|---|---|---|---|---|---|
| SkinCeuticals Future Mineral UV Defense Invisble Sunscreen Mineral Filters Broad Spectrum SPF 50 | TITANIUM DIOXIDE AND ZINC OXIDE | L'Oreal USA Products Inc | 0b92a940-0dd4-4266-bd47-88c27def62c0 | 2026-05-20 | Warnings | 15FIX9V2JP |
| WHITENING SUNSCREENANTI WRINKLE | WHITENING SUNSCREENANTI WRINKLE | Shantou Oushiya Biotechnology Co.,Ltd | 524384e9-b3f8-4c13-e063-6394a90a8973 | 2026-05-20 | Warnings | 15FIX9V2JP |
| IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50 | TITANIUM DIOXIDE AND ZINC OXIDE | L'Oreal USA Products Inc. | fded7dfb-ffb9-4fb0-9511-273e0e126969 | 2026-05-20 | Warnings | 15FIX9V2JP |
| Freaks of Nature Peak Performance Broad Spectrum SPF 50 | FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 50 | THE FREAKS OF NATURE, INC. | 5247187d-a14c-6468-e063-6394a90ace3e | 2026-05-20 | Warnings | 15FIX9V2JP |
| Dentaforce | ANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUM | BioActive Nutritional, Inc. | 82321547-e04a-42ff-aa39-6a192638e5a2 | 2026-05-18 | Warnings | ETJ7Z6XBU4 |
| LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUM | TITANIUM DIOXIDE AND ZINC OXIDE | LOreal USA Products Inc. | 23cc5ff4-f842-4e3e-ac5c-23dbaf7d3914 | 2026-05-15 | Warnings | 15FIX9V2JP |
| LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUM | TITANIUM DIOXIDE AND ZINC OXIDE | SICOS ET CIE | c688f8e6-2cd2-40db-b03f-90fd74c2d89c | 2026-05-15 | Warnings | 15FIX9V2JP |
| Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 Sunscreen | OCTINOXATE AND TITANIUM DIOXIDE | L'Oreal USA Products Inc | 7df9dbd2-7db9-4961-819d-e93d14a065c3 | 2026-05-15 | Warnings | 15FIX9V2JP |
| Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 Sunscreen | OCTINOXATE AND TITANIUM DIOXIDE | SICOS ET CIE | 20efd5fa-3077-4fd4-82d0-ddca946e4528 | 2026-05-15 | Warnings | 15FIX9V2JP |
| MELAO Hydrating Lightweight Sunscreen | OCTOCRYLENE,HOMOSALATE,ETHYLHEXYL SALICYLATE,PHENYLBENZIMIDAZOLE SULFONIC ACID,BUTYL METHOXYDIBENZOYLMETHANE,TITANIUM DIOXIDE | Guangdong Aimu Biological Technology Co., Ltd | 51c353cb-94c4-e110-e063-6394a90a497e | 2026-05-14 | Warnings | 15FIX9V2JP |
| C07 STRONG LIGAMENTS AND JOINTS | ARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALE | Apex Energetics Inc. | bccf8c83-a6cd-e58c-e053-2a95a90a43d7 | 2026-05-13 | Warnings | ETJ7Z6XBU4 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Coupler LLC | 519e54e0-a613-e7b3-e063-6294a90a4452 | 2026-05-12 | Warnings, Adverse reactions | 995258 76755771U3 |
| Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark | TITANIUM DIOXIDE AND ZINC OXIDE | SENT, Inc. | aedde765-931f-430e-9fc3-d87bde2b78cd | 2026-05-12 | Warnings | 15FIX9V2JP |
| Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - Medium | TITANIUM DIOXIDE AND ZINC OXIDE | SENT, Inc. | 417305d7-d32e-4bc9-8f77-0a42b6bdecf5 | 2026-05-12 | Warnings | 15FIX9V2JP |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 413a39ce-98d6-40f5-9048-ad464e98de44 | 2026-05-11 | Warnings, Adverse reactions | 995218 76755771U3 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 7edd582c-039c-4bdc-bf8a-61eac8a5a9a0 | 2026-05-11 | Warnings, Adverse reactions | 995258 76755771U3 |
| The Perfect Derma Mineral Perfection Broad Spectrum SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | Bella Medical Products LLC | 518f69fc-fd39-8195-e063-6294a90a3fdd | 2026-05-11 | Warnings | 15FIX9V2JP |
| Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral Sunscreen | RADICAL RESCUE SPF 30 MINERAL SUNSCREEN | ProTransit, Inc. | 38e0139c-bb87-55ba-e063-6294a90a82ee | 2026-05-11 | Warnings | 15FIX9V2JP |
| EELHOE Sunscreen | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 5196ccb0-4515-7e40-e063-6394a90a09bd | 2026-05-11 | Warnings | 15FIX9V2JP |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Preferred Pharmaceuticals Incl | 63fdf791-1a58-45ba-8ef2-15b80bb24f23 | 2026-05-11 | Warnings, Adverse reactions | 995258 76755771U3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.