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 |
|---|---|---|---|---|---|---|
| Sei Bella Tinted BB Moisturizing Cream | 115 N | Melaleuca Inc. | 2f132cc0-e8e3-35e3-e063-6394a90a4f3d | 2026-03-17 | Warnings | 15FIX9V2JP |
| Tinted Sunscreen Broad SPF30 | TINTED SUNSCREEN BROAD SPF30 | DOSCHER FAMILY HEALTH NP P.C. | 4d4021ba-4b29-6b81-e063-6294a90a5ea7 | 2026-03-17 | Warnings | 15FIX9V2JP |
| BM BIO18 | CALC FLUOR, CALC SULF, SILICEA. | BM Private Limited | 4d269a3b-18ba-3ad2-e063-6294a90a1fae | 2026-03-16 | Warnings | ETJ7Z6XBU4 |
| HYDRATING TINTED MOISTURIZER SPF50 | HYDRATING TINTED MOISTURIZER SPF50 | NING PTE. LTD. | 4cf8d3d3-eebf-2da0-e063-6294a90a7065 | 2026-03-14 | Warnings | 15FIX9V2JP |
| TINTED WATERY SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | KSISTERS PTE. LTD. | 4ced53d0-8bfc-ff8e-e063-6294a90a9dbd | 2026-03-13 | Warnings | 15FIX9V2JP |
| Daily Moisturizing Mineral Sunscreen | BROAD SPECTRUM SPF30 | EDINA PLASTIC SURGERY,LTD. | 4d056e2b-5813-da42-e063-6294a90ac519 | 2026-03-13 | Warnings | 15FIX9V2JP |
| Ligatone | ARNICA MONTANA, BRYONIA, CALCAREA PHOSPHORICA, CAUSTICUM, KALI CARBONICUM, MANGANESE GLUCONATE, MEZEREUM, RHUS TOX, RUTA GRAVEOLENS, SILICEA | BioActive Nutritional, Inc. | 3a3bdd55-daec-43b9-a380-54a747fb7d10 | 2026-03-13 | Warnings | ETJ7Z6XBU4 |
| Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440C | TITANIUM DIOXIDE | Kenvue Brands LLC | 4c335d9c-40ca-c0ce-e063-6394a90ac20a | 2026-03-11 | Warnings | 15FIX9V2JP |
| Lower GI and Probiotic Restoration | AETHUSA CYNAPIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, CONDURANGO, GAMBOGIA, GRATIOLA OFFICINALIS, LAC VACCINUM, LACTICUM ACIDUM, NATRUM CARBONICUM, NUX VOMICA, PODOPHYLLUM PELTATUM, SEPIA AND SILICEA. | King Bio Inc. | 2e1f3ca1-9036-4f14-bd3c-d0eed9a9ff93 | 2026-03-10 | Warnings | ETJ7Z6XBU4 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Kesin Pharma | 4b094d1b-97b2-6ca6-e063-6294a90a2437 | 2026-03-10 | Warnings, Adverse reactions | 76755771U3 |
| Constitutional Enhancer | ACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR. | King Bio Inc. | 448becd7-58aa-40ae-9b4b-39f48a8f13dd | 2026-03-10 | Warnings | ETJ7Z6XBU4 |
| Vermiclear | GRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CINCHONA OFFICINALIS, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PODOPHYLLUM PELTATUM, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUM | Energique, Inc. | f7cf3edd-2451-4a4f-b1f2-1b3db2bb4dca | 2026-03-09 | Warnings | ETJ7Z6XBU4 |
| cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50 | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 4490f968-46b6-44d2-af2d-5130b52c8861 | 2026-03-05 | Warnings | 15FIX9V2JP |
| Osteoplex | EQUISETUM HYEMALE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, MANGANUM MURIATICUM, SYMPHYTUM OFFICINALE, MEDULLA OSSIS SUIS, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA, PARATHYROID GLAND (SUIS), LIGAMENT (SUIS) | BioActive Nutritional, Inc. | 8a7e1397-a387-4f2c-ab4f-7f1a7f1a849b | 2026-03-05 | Warnings | ETJ7Z6XBU4 |
| Respiforce A-HP | ARSENICUM ALBUM, BELLADONNA, IPECACUANHA, KALI CARBONICUM, LOBELIA INFLATA, NATRUM SULPHURICUM, SILICEA | BioActive Nutritional, Inc. | ebf5f0c7-e7a4-45fe-acfd-52c46a8d789c | 2026-03-05 | Warnings | ETJ7Z6XBU4 |
| Sinus Defense 2.0 | LAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE | Micro Balance Health Products LLC | 560f84f6-2544-4ba8-8236-a95906eb7d97 | 2026-03-04 | Warnings | ETJ7Z6XBU4 |
| Snore Control | BROMIUM, CHAMOMILLA, CINCHONA, CUPRUM METALLICUM, HELLEBORUS NIGER, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LAUROCERASUS, NUX VOMICA, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, STRAMONIUM, SULPHUR AND ZINCUM METALLICUM. | King Bio Inc. | 704bb574-6c54-49d1-bdae-81ffe0e79d10 | 2026-03-04 | Warnings | ETJ7Z6XBU4 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Aurobindo Pharma Limited | 9de2de56-614f-4294-8794-d30758cf5f70 | 2026-03-03 | Warnings, Adverse reactions | 995218 995281 995258 76755771U3 |
| 911 Adrenal Burnout and Fatigue | ACETICUM AC, ADRENALINUM, ADRENOCORTICOTROPHIN (30X), AESCULUS HIPPOCASTANUM, FLOS, ALFALFA, ALPHA-LIPOIC AC, AMBRA, ARG NIT, AVENA SATIVA, BRYONIA, CARBONEUM OXYGENISATUM, CARPINUS BETULUS, FLOS, DNA, FUMARICUM ACIDUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS, KALI PHOSPHORICUM, LACTICUM ACIDUM, LECITHIN, NATRUM MURIATICUM, OXALICUM ACIDUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SEPIA, SILICEA, SUCCINICUM ACIDUM AND THYROIDINUM. | King Bio Inc. | 21c6b6c1-e846-4f25-a1dc-02e79d1be756 | 2026-02-26 | Warnings | ETJ7Z6XBU4 |
| TIBENA EVERY DAY REAL SUN BLOCK | TITANIUM DIOXIDE, ZINC OXIDE | KONAD CO LTD | 211c9930-4f91-cf8f-e063-6394a90a97b3 | 2026-02-26 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.