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 |
|---|---|---|---|---|---|---|
| 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 |
| SPF50 Plus Mineral Sunscreen | ZINC OXIDE AND TITANIUM DIOXIDE | KAS Direct LLC dba BabyGanics | 08e8bc10-85d8-4215-8351-7ec12029416c | 2024-10-17 | Warnings | 15FIX9V2JP |
| MINERAL SUNSCREEN SPF 50 | ZINC OXIDE, TITANIUM DIOXIDE | WEGMANS FOOD MARKETS INC | bfe24f55-d0e5-254a-e053-2995a90a2fd3 | 2024-10-16 | Warnings | 15FIX9V2JP |
| Equate Sunscreen SPF 50 KIDS Broad Spectrum | TITANIUM DIOXIDE, ZINC OXIDE | WAL-MART STORES INC | 81cb6b2e-1ca3-4a83-a8df-9bfee61e79af | 2024-10-16 | Warnings | 15FIX9V2JP |
| MINERAL BASED SPF 50 SUNSCREEN | ZINC OXIDE, TITANIUM DIOXIDE | THE KROGER COMPANY | a4e6936d-a76c-e8fd-e053-2995a90a965f | 2024-10-15 | Warnings | 15FIX9V2JP |
| TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious Formula | TITANIUM DIOXIDE, ZINC OXIDE | TOPCO ASSOCIATES LLC | f14f43e6-ee57-5495-e053-2a95a90a4011 | 2024-10-15 | Warnings | 15FIX9V2JP |
| MINERAL SUNSCREEN SPF 50 | ZINC OXIDE, TITANIUM DIOXIDE | TOPCO ASSOCIATES LLC | bfe076fa-f21f-2c46-e053-2a95a90acee4 | 2024-10-15 | Warnings | 15FIX9V2JP |
| H.E.B. Mineral Sunscreen Broad Spectrum SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | H.E.B. | c5279caf-3af9-d163-e053-2995a90a943b | 2024-10-15 | Warnings | 15FIX9V2JP |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 99995bdb-a35f-7753-e053-2995a90a683c | 2024-10-15 | Warnings, Adverse reactions | 995281 76755771U3 |
| Target Up and Up Mineral Sunscreen Broad Spectrum SPF 50 Reef-Conscious Formula | TITANIUM DIOXIDE, ZINC OXIDE | TARGET CORPORATION | cfd735d2-df3a-5ed0-e053-2995a90a9f26 | 2024-10-14 | Warnings | 15FIX9V2JP |
| Target Up and Up SPF 50 Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | TARGET CORPORATION | f99028fa-a17e-4a84-e053-6294a90a927f | 2024-10-14 | Warnings | 15FIX9V2JP |
| AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102 | ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE | AMOREPACIFIC CORPORATION | 531f60c9-c89a-46bc-8460-d01b2e838e6f | 2024-10-08 | Warnings | 15FIX9V2JP |
| AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104 | OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE | AMOREPACIFIC CORPORATION | 60964d9f-d96c-4397-b273-6b63d1886722 | 2024-10-08 | Warnings | 15FIX9V2JP |
| IOPE AIR CUSHION Cover 21 Vanilla | ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE | AMOREPACIFIC CORPORATION | 29d6cc8d-1469-479d-a15a-e78d4e22d4a2 | 2024-10-08 | Warnings | 15FIX9V2JP |
| Granite 30X | GRANITE 30X | True Botanica, LLC | 21b2bae6-8176-ccbf-e063-6394a90a97b5 | 2024-10-07 | Warnings | ETJ7Z6XBU4 |
| EMF Protect and Balance | ALFALFA, CADMIUM SULPHURATUM, CALCAREA CARBONICA, CUPRUM METALLICUM, FERRUM METALLICUM, FUCUS VESICULOSUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, MERCURIUS VIVUS, PLUMBUM METALLICUM, SILICEA, SYMPHYTUM OFFICINALE, TARENTULA CUBENSIS, X-RAY, YTTERBIUM OXIDE | Deseret Biologicals, Inc. | 9ea8dfe3-7d95-4b86-8e1f-dc9e414e854a | 2024-10-04 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.