NDC 53401-034-53 - 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
- 53401-034-53
- 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 |
|---|---|---|---|---|---|---|
| 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 |
| CVS Health 60 Plus Sensitive Skin Sun | TITANIUM DIOXIDE, ZINC OXIDE | CVS Pharmacy | 477c25ec-33db-04a6-e054-00144ff8d46c | 2024-10-22 | Warnings | 15FIX9V2JP |
| Bali Body Tinted Super Serum Natural SPF 30 | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Bali Body Pty Ltd | f5eeaf37-33f2-2c0c-e053-2a95a90abcc0 | 2024-10-21 | Warnings | 15FIX9V2JP |
| Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Fruit Of The Earth, Inc. | f42a0b1e-038d-4fab-e053-2995a90a5364 | 2024-10-18 | Warnings | 15FIX9V2JP |
| Fruit of the Earth Sun Town City Mineral SPF 30 Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Fruit Of The Earth, Inc. | f4481bf3-6dc7-5641-e053-2a95a90ad938 | 2024-10-18 | Warnings | 15FIX9V2JP |
| Fruit of the Earth Sun Town City Mineral SPF 50 Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Fruit Of The Earth, Inc. | f45d25d2-9305-5858-e053-2a95a90a7f7b | 2024-10-18 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.