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 |
|---|---|---|---|---|---|---|
| Neutrogena MINERAL UV TINT FACE MEDIUM DEEP SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | Acupac Packaging, Inc | 4ee39bbf-b7d7-8f87-e063-6294a90a2539 | 2026-04-07 | Warnings | 15FIX9V2JP |
| H-Focus Formula | AGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUM | Healing Natural Oils LLC | 4ee42911-3064-7f55-e063-6294a90abcc7 | 2026-04-07 | Warnings | ETJ7Z6XBU4 |
| H-Mood Formula | AGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUM | Healing Natural Oils LLC | 4ee5c82e-9edf-c36e-e063-6394a90a237f | 2026-04-07 | Warnings | ETJ7Z6XBU4 |
| Nu Colour Bioadaptive BB plus Foundation - Beige | TITANIUM DIOXIDE | NSE Products, Inc. | f74e83fe-41a0-4998-ae53-30ed5af47592 | 2026-04-07 | Warnings | 15FIX9V2JP |
| EltaMD Skincare UV AOX Elements SPF50 Tinted | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 2c74209d-9b88-4c32-ad42-cd6de16c1fef | 2026-04-03 | Warnings | 15FIX9V2JP |
| EltaMD UV Restore Tinted | TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 4fc18856-01b3-43ed-9e1b-b4394e31aa3c | 2026-04-03 | Warnings | 15FIX9V2JP |
| Sunscreen for baby SPF50plus | OCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATE | Guangzhou Senmai Biotechnology Co., Ltd. | 1cb7fbca-0874-ae53-e063-6294a90ab42a | 2026-04-02 | Warnings | 15FIX9V2JP |
| TiZO3 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | 4e7bdec2-abcc-0267-e063-6394a90ae47a | 2026-04-02 | Warnings | 15FIX9V2JP |
| EltaMD UV Restore | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 17b47994-82d6-4f9d-8249-bdb55106c9b3 | 2026-04-02 | Warnings | 15FIX9V2JP |
| Sinus Defense | LAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE | Micro Balance Health Products LLC | 9c2f51c5-aa41-414e-a966-32e02e9e79a2 | 2026-04-02 | Warnings | ETJ7Z6XBU4 |
| Clinical Skin Filter Tinted Sunscreen | CLINICAL SKIN FILTER TINTED SUNSCREEN | BY KIN AESTHETICS LLC | 4e69a8a3-8dbb-577a-e063-6294a90a6a23 | 2026-04-01 | Warnings | 15FIX9V2JP |
| Krx Aesthetics All Day Glow Sunblocker | KRX AESTHETICS ALL DAY GLOW SUNBLOCKER | BY KIN AESTHETICS LLC | 4e69df43-393b-bc09-e063-6394a90a275a | 2026-04-01 | Warnings | 15FIX9V2JP |
| spf 50 mineral powder sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Smalls Brand LLC DBA Roe Wellness | f8762dd1-0484-74ea-e053-6294a90ac112 | 2026-03-31 | Warnings | 15FIX9V2JP |
| SeranovaTM ULTRALIGHT SPF50 SERUM | SERANOVATM ULTRALIGHT SPF50 SERUM | Guangzhou Ariel Biotech Co., Ltd. | 4e5d716d-2b2d-d42f-e063-6294a90a1e52 | 2026-03-31 | Warnings | 15FIX9V2JP |
| Acne HP | CARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUM | BioActive Nutritional, Inc. | 2ab4ff53-4274-40c7-b05c-44d918d809be | 2026-03-31 | Warnings | ETJ7Z6XBU4 |
| Lymphoplex | MYRRHA, TRIGONELLA FOENUM-GRAECUM, PINUS SYLVESTRIS, LYMPH (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRANGEA ARBORESCENS, PHYTOLACCA DECANDRA, SILICEA | BioActive Nutritional, Inc. | 624f35db-291e-4e7f-a2c9-ae319717157a | 2026-03-30 | Warnings | ETJ7Z6XBU4 |
| Equisetum Silicea | EQUISETUM SILICEA | Uriel Pharmacy Inc. | e88b820b-4a07-42e2-8fe2-b30729e91a8c | 2026-03-30 | Warnings | ETJ7Z6XBU4 |
| B Force HP | APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA | BioActive Nutritional, Inc. | 811c6f32-fcad-464c-bcf6-ae6a59195b1c | 2026-03-30 | Warnings | ETJ7Z6XBU4 |
| Lymphdrainex | GERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA, | Energique, Inc. | c512f211-f4f8-46f6-87ed-dd50287359df | 2026-03-27 | Warnings | ETJ7Z6XBU4 |
| UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADE | TITANIUM DIOXIDE AND ZINC OXIDE | CLINIQUE LABORATORIES LLC | 4e0bd355-99c6-8cf4-e063-6294a90ab4b3 | 2026-03-27 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.