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 |
|---|---|---|---|---|---|---|
| SFL SUNSCREEN - SOL DEFENSE SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | Lifeline Medical, Inc | 5438c185-31c9-c51e-e063-6394a90ae9ef | 2026-06-14 | Warnings | 15FIX9V2JP |
| BM Tooth Remineralization | CALC PHOS, CALC FLUOR, SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 543bc298-ec32-38e9-e063-6394a90aac15 | 2026-06-14 | Warnings | ETJ7Z6XBU4 |
| Nail Fungus Control Extra Strength | CALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUM | Forces of Nature | d02b88a6-1999-4dcd-91b5-fad88a664fcb | 2026-06-14 | Warnings | ETJ7Z6XBU4 |
| Nerve Pain | ARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUM | Forces of Nature | a9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb7 | 2026-06-14 | Warnings | ETJ7Z6XBU4 |
| Scar Control | CALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDE | Forces of Nature | 595c3423-6b52-48fc-8a95-00b53c1ecc7b | 2026-06-14 | Warnings | ETJ7Z6XBU4 |
| BM BM186 DROPS | ARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 54243745-bd67-19c1-e063-6394a90a4b72 | 2026-06-13 | Warnings | ETJ7Z6XBU4 |
| BM BM186 DROPS | ARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICA | BM Private Limited | 540d8fbe-3bdb-1b54-e063-6394a90a114d | 2026-06-12 | Warnings | ETJ7Z6XBU4 |
| BM BM5 DROPS | APIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCC | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 540e4ee3-596f-4cea-e063-6294a90a6a60 | 2026-06-12 | Warnings | ETJ7Z6XBU4 |
| Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | SKINBETTER SCIENCE LLC | 54106748-9810-d3ff-e063-6394a90a5b7a | 2026-06-12 | Warnings | 15FIX9V2JP |
| Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | SKINBETTER SCIENCE LLC | 5410e0ed-aed5-3279-e063-6294a90a0c3e | 2026-06-12 | Warnings | 15FIX9V2JP |
| it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 Sunscreen | ENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDE | IT COSMETICS, LLC | f2990320-b61d-40b8-ba79-18d6b37e7f52 | 2026-06-11 | Warnings | 15FIX9V2JP |
| Jacksons Cell Salts SKIN BALANCE | CALC SULPH, KALI SULPH, SILICEA | Zettl Health Inc. | 54012f03-4c34-42f5-e063-6394a90aacc5 | 2026-06-11 | Warnings | ETJ7Z6XBU4 |
| BM BM5 DROPS | APIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCC | BM Private Limited | 53e763ee-9a44-a914-e063-6394a90aeb3c | 2026-06-10 | Warnings | ETJ7Z6XBU4 |
| GUNA-AWARENESS | BETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN - | Guna spa | 10e46b39-7903-4390-b72d-865291245b4c | 2026-06-10 | Warnings | ETJ7Z6XBU4 |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | BM Private Limited | 53d1c51a-77eb-bb3c-e063-6394a90aab3f | 2026-06-09 | Warnings | ETJ7Z6XBU4 |
| BM BIO18 | CALC FLUOR, CALC SULF, SILICEA. | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53d3c1d6-d0ba-5ea7-e063-6394a90a0294 | 2026-06-09 | Warnings | ETJ7Z6XBU4 |
| RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20 | OCTINOXATE AND TITANIUM DIOXIDE | ESTEE LAUDER INC | 53d76b02-442e-7a5d-e063-6394a90ae1b3 | 2026-06-09 | Warnings | 15FIX9V2JP |
| FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20 | OCTINOXATE AND TITANIUM DIOXIDE | ESTEE LAUDER INC | 53d9d689-4a86-5b9c-e063-6394a90aef18 | 2026-06-09 | Warnings | 15FIX9V2JP |
| BM Silicea | SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53bb3927-6053-eb3d-e063-6394a90a5ddf | 2026-06-08 | Warnings | ETJ7Z6XBU4 |
| Scrofularoforce | RUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANA | BioActive Nutritional, Inc. | 737cd410-0405-41b0-b7f2-29bb20037849 | 2026-06-08 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.