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 |
|---|---|---|---|---|---|---|
| Lymphastat | BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUM | Energique, Inc. | ed3e0362-a4d3-46fa-a045-17bf659b777c | 2024-10-28 | Warnings | ETJ7Z6XBU4 |
| Hypothalmupar | ARALIA QUINQUEFOLIA, GINKGO BILOBA, HYDROCOTYLE ASIATICA, CEREBRUM SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PHOSPHORUS, SILICEA | Energique, Inc. | 8b01e718-83b7-4f93-8fea-d0e37c756185 | 2024-10-28 | Warnings | ETJ7Z6XBU4 |
| Banana Boat Kids Mineral Protection SPF50 | TITANIUM DIOXIDE,ZINC OXIDE | Edgewell Personal Care Brands LLC | dc7701b5-0c73-b4df-e053-2a95a90a0f1b | 2024-10-27 | Warnings | 15FIX9V2JP |
| Banana Boat Mineral Sensitive SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Edgewell Personal Care Brands LLC | dc7913d5-58f2-3077-e053-2a95a90a1627 | 2024-10-27 | Warnings | 15FIX9V2JP |
| Banana Boat Mineral Sensitive Face SPF50 | TITANIUM DIOXIDE, ZINC OXIDE | Edgewell Personal Care Brands LLC | dc783438-b28f-b7f4-e053-2a95a90a3d65 | 2024-10-27 | Warnings | 15FIX9V2JP |
| Banana Boat Sport Mineral SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Edgewell Personal Care Brands LLC | dc79790f-e2bc-5414-e053-2a95a90a9e7a | 2024-10-27 | Warnings | 15FIX9V2JP |
| TiZO Mineral Stick - Tinted SPF 45 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | fd6d0080-0bef-4e7e-8ca5-b859639efd0c | 2024-10-25 | Warnings | 15FIX9V2JP |
| TiZO Mineral Stick Non-Tinted SPF 45 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | e7044f18-992a-4f60-9a2b-f11ed06db09b | 2024-10-25 | Warnings | 15FIX9V2JP |
| CoTZ Lip Balm | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | 479a7d82-a068-4c2e-b50b-555c40e13e37 | 2024-10-25 | Warnings | 15FIX9V2JP |
| TiZO Mineral Sun Defense SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals Ltd. | e17a8c35-2d49-4c99-b154-ea673c14753e | 2024-10-25 | Warnings | 15FIX9V2JP |
| IPKN Moist and Firm Beauty Balm Light Medium | TITANIUM DIOXIDE | Inel Cosmetics Co., Ltd. | 1af6184e-3dc4-4eb3-8d51-aca724473451 | 2024-10-25 | Warnings | 15FIX9V2JP |
| IPKN Moist and Firm Beauty Balm Light | TITANIUM DIOXIDE | Inel Cosmetics Co., Ltd. | 77d77838-aa13-4939-a1a0-50189fbb3fe0 | 2024-10-25 | Warnings | 15FIX9V2JP |
| Hydroxyzine Hydrochloride | HYDROXYZINE | Amneal Pharmaceuticals LLC | 89901966-724b-4773-98b8-ea663ceabd53 | 2024-10-25 | Warnings, Adverse reactions | 995218 995281 995258 76755771U3 |
| FATIGUE NOSODE EB | ASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARANEA DIADEMA, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA, SEPIA, EPSTEIN-BARR VIRUS NOSODE | Energique, Inc. | 36d963cc-fd47-40ee-aa73-c2e7fcedf192 | 2024-10-24 | Warnings | ETJ7Z6XBU4 |
| Complexion HP | CARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUM | Energique, Inc. | ad12d51e-04cb-4833-b802-0038796966ff | 2024-10-24 | Warnings | ETJ7Z6XBU4 |
| Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44N | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Rare Beauty, LLC | cffbb6af-5a04-f58a-e053-2995a90a1ae2 | 2024-10-23 | Warnings | 15FIX9V2JP |
| Banana Boat | TITANIUM DIOXIDE, ZINC OXIDE | Edgewell Personal Care Brands, LLC | 441a46f0-ecda-4448-e054-00144ff88e88 | 2024-10-23 | Warnings | 15FIX9V2JP |
| Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28C | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Rare Beauty, LLC | cffb8219-7076-de64-e053-2a95a90a6036 | 2024-10-23 | Warnings | 15FIX9V2JP |
| Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10N | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Rare Beauty, LLC | cfee02eb-92f9-be12-e053-2a95a90a4337 | 2024-10-23 | Warnings | 15FIX9V2JP |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Chartwell RX, LLC | 53b2d731-f38a-47c0-9e5c-abd3b45e2fe1 | 2024-10-22 | Warnings, Adverse reactions | 76755771U3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.