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 |
|---|---|---|---|---|---|---|
| ONETOOTHCLINIC TOOTH | SILICON DIOXIDE, TOCOPHEROL ACETATE, SODIUM PYROPHOSPHATE | CONE MEDICAL Co., Ltd. | 9a567c9e-b8ce-7bf1-e053-2995a90aff2b | 2025-12-30 | Warnings | ETJ7Z6XBU4 |
| ONETOOTH CLINIC TOOTH | SILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATE | CONE MEDICAL Co., Ltd. | bd50abcd-8a85-2923-e053-2995a90a109b | 2025-12-30 | Warnings | ETJ7Z6XBU4 |
| Ageless Glow Serum BB Cream Sunscreen SPF 40 - Fair | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 473738b4-7c36-8edf-e063-6394a90ad24b | 2025-12-30 | Warnings | 15FIX9V2JP |
| Ageless Glow Serum BB Cream Sunscreen SPF 40 - Medium Tan | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 47387d5f-e77b-5633-e063-6294a90a5584 | 2025-12-30 | Warnings | 15FIX9V2JP |
| Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 4738be66-0fe8-148e-e063-6394a90a1b02 | 2025-12-30 | Warnings | 15FIX9V2JP |
| Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan Deep | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 4738eed1-9f72-5fd8-e063-6394a90a26bd | 2025-12-30 | Warnings | 15FIX9V2JP |
| Ageless Glow Serum BB Cream Sunscreen SPF 40 - Deep | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 4739179e-88b3-8820-e063-6394a90aa211 | 2025-12-30 | Warnings | 15FIX9V2JP |
| SPF 30 Sunscreen | ZINC OXIDE, TITANIUM DIOXIDE | CLEURE | f5512f34-08ee-b0f6-e053-2a95a90ab5bd | 2025-12-29 | Warnings | 15FIX9V2JP |
| RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20 | OCTINOXATE AND TITANIUM DIOXIDE | ESTEE LAUDER INC | 897b8edb-f089-4a49-baca-e05806b0a068 | 2025-12-29 | Warnings | 15FIX9V2JP |
| OI LIN SUNMILK SUNSCREEN SPF 30 | SUNSCREEN, TITANIUM DIOXIDE | Sunrider Manufacturing L.P. | 26b57314-1616-4ca4-b65f-a363c525b432 | 2025-12-29 | Warnings | 15FIX9V2JP |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Northwind Health Company, LLC | c134195e-a048-530a-e053-2a95a90ad9f8 | 2025-12-26 | Warnings, Adverse reactions | 995218 76755771U3 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Northwind Health Company, LLC | c13455a3-3078-4fe1-e053-2a95a90adf8e | 2025-12-26 | Warnings, Adverse reactions | 995258 76755771U3 |
| StellaLife VEGA Oral Care | SPRAY | StellaLife, Inc. | b8ba495e-2cfe-092c-e053-2995a90a3fd3 | 2025-12-24 | Warnings | ETJ7Z6XBU4 |
| StellaLife VEGA Oral Care Recovery Kit | KIT | Homeocare Laboratories, Inc. | b701234a-0bd2-16d3-e053-2995a90a5b13 | 2025-12-24 | Warnings | ETJ7Z6XBU4 |
| HydrOXYzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Northstar RxLLC | 8e5fce17-936e-46ea-a969-518c952c2091 | 2025-12-23 | Warnings, Adverse reactions | 995218 995281 995258 76755771U3 |
| TINTED FACIAL SUNSCREEN | ZINC OXIDE, TITANIUM DIOXIDE | Guangzhou Tata Biotechnology Co., Ltd. | 1259035e-9196-97de-e063-6394a90a9dec | 2025-12-22 | Warnings | 15FIX9V2JP |
| SPF 50 MINERAL SUNSCREEN LIP | ZINC OXIDE , TITANIUM DIOXIDE | Guangzhou Tata Biotechnology Co., Ltd. | 1c6f0964-9bee-1c06-e063-6294a90ac2a4 | 2025-12-22 | Warnings | 15FIX9V2JP |
| G.M. Collin FPS-SPF 50 UVA-UVB TINTED SUNSCREEN | ZINC OXIDE, TITANIUM DIOXIDE | LABORATOIRES DERMO-COSMETIK INC. | 468c90d7-3b9e-1641-e063-6394a90a928c | 2025-12-22 | Warnings | 15FIX9V2JP |
| TiZO3 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals Ltd. | 468d6476-127a-e9f0-e063-6294a90a3df9 | 2025-12-22 | Warnings | 15FIX9V2JP |
| YOUR SKIN BUT BETTER FAIR | TITANIUM DIOXIDE AND ZINC OXIDE | IT COSMETICS, LLC | 3e65ec1a-0ed9-433d-8da9-a6cb61829911 | 2025-12-22 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.