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 |
|---|---|---|---|---|---|---|
| Protectif Deep Tint | ZINC OXIDE AND TITANIUM DIOXIDE | Derma Research Group Inc. | 19b19023-1340-6609-e063-6394a90a6eaf | 2024-05-30 | Warnings | 15FIX9V2JP |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 16a63845-6619-293b-e063-6394a90a0a5c | 2024-05-28 | Warnings, Adverse reactions | 76755771U3 |
| COOLA Mineral Liplux Lip Balm SPF 30 Nude Beach | TITANIUM DIOXIDE, ZINC OXIDE | COOLA, LLC | ee2842c3-65e0-3904-e053-2a95a90aabff | 2024-05-22 | Warnings | 15FIX9V2JP |
| COOLA Mineral Liplux Lip Balm SPF 30 Firecracker | TITANIUM DIOXIDE, ZINC OXIDE | COOLA, LLC | ee026a1c-885b-256f-e053-2a95a90af564 | 2024-05-22 | Warnings | 15FIX9V2JP |
| Bare Republic SPF 50 Mineral Sunscreen Vanilla Coco | TITANIUM DIOXIDE, ZINC OXIDE | COOLA, LLC | ec96dee8-85e8-3147-e053-2995a90aaf53 | 2024-05-22 | Warnings | 15FIX9V2JP |
| COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Bronze Goddess | TITANIUM DIOXIDE | COOLA, LLC | eeb406c6-a543-379a-e053-2995a90a4998 | 2024-05-22 | Warnings | 15FIX9V2JP |
| COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh Rose | TITANIUM DIOXIDE | COOLA, LLC | ee01642f-478e-b307-e053-2a95a90a7d81 | 2024-05-22 | Warnings | 15FIX9V2JP |
| Bare Republic Mineral Matte Untinted Face SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | COOLA, LLC | ecabcc89-fb09-41a9-e053-2995a90a8b31 | 2024-05-22 | Warnings | 15FIX9V2JP |
| Bare Republic Mineral Matte Tinted Face SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | COOLA, LLC | ee018c21-dca7-28aa-e053-2a95a90a3bdb | 2024-05-22 | Warnings | 15FIX9V2JP |
| Bare Republic Mineral Shimmer SPF 30 Golden Daze | TITANIUM DIOXIDE, ZINC OXIDE | COOLA, LLC | eeb70034-0f8d-a46d-e053-2a95a90a8130 | 2024-05-22 | Warnings | 15FIX9V2JP |
| Bare Republic Mineral Shimmer SPF 30 Diamond Dust | TITANIUM DIOXIDE, ZINC OXIDE | COOLA, LLC | eec83ecb-d0ab-7857-e053-2995a90a40ed | 2024-05-22 | Warnings | 15FIX9V2JP |
| Multiple Miasm | ACONITUM NAPELLUS, ALOE, ARSENICUM ALBUM, AURUM METALLICUM, BRYONIA (ALBA), CACTUS GRANDIFLORUS, CALCAREA SULPHURICA, CINCHONA OFFICINALIS, HURA BRASILIENSIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, PHOSPHORUS, SARCOLACTICUM ACIDUM, SILICEA, STRAMONIUM, SULPHUR, TARENTULA HISPANA, TEUCRIUM MARUM, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 92c97bf6-8dd9-43a9-b686-75420b029197 | 2024-05-21 | Warnings | ETJ7Z6XBU4 |
| Osteopar | EQUISETUM HYEMALE, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, MEDULLA OSSIS SUIS, OLEUM MORRHUAE, SILICEA, HEKLA LAVA | Energique, Inc. | 6c346a26-26a2-4be0-b8a3-bbb5709bcf3d | 2024-05-21 | Warnings | ETJ7Z6XBU4 |
| Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | June Jacobs Labs LLC | 18e1edd9-e39b-c91f-e063-6394a90a32a0 | 2024-05-20 | Warnings | 15FIX9V2JP |
| Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | June Jacobs Labs, LLC | 18e4c50d-eb91-c269-e063-6394a90a7999 | 2024-05-20 | Warnings | 15FIX9V2JP |
| Colopar | COLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALIS | Energique, Inc. | c47d7203-abcd-4ae5-bf9b-5df07e07d3c1 | 2024-05-20 | Warnings | ETJ7Z6XBU4 |
| Protectif Untinted | ZINC OXIDE AND TITANIUM DIOXIDE | Allure Labs | 18aa2604-c8f0-ca04-e063-6294a90a1c25 | 2024-05-17 | Warnings | 15FIX9V2JP |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | 138ec5c1-bb06-2a82-e063-6394a90ab42b | 2024-05-17 | Warnings, Adverse reactions | 995281 76755771U3 |
| Aging Eye Formula | CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, GERMANIUM METALLICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, NATRUM MURIATICUM | Nutritional Specialties, Inc. | 4510fe59-cc28-4585-925f-42508a60abd0 | 2024-05-13 | Warnings | ETJ7Z6XBU4 |
| Jack Black | TITANIUM DIOXIDE, ZINC OXIDE | Jack Black L.L.C | 181d5bf3-ce91-cb2c-e063-6294a90a51c4 | 2024-05-10 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.