FDA.reportPublic FDA data

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 table
LabelManufacturerEffective dateType
HYDROXYZINE HYDROCHLORIDE - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2026-09-16HUMAN 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.

Matched openFDA labels page 81 of 138 · 2,750 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products Silicea 8xSILICEABestmade Natural Products31e15fbf-2439-8d96-e063-6294a90a46ed2025-04-03WarningsExact identifier
unii: ETJ7Z6XBU4
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack5ff091be-6e30-4305-a172-769ee45e110b2025-04-02Warnings, Adverse reactionsExact identifier
rxcui: 995281
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepackdd9e5dc5-720c-4de8-abae-6404c31f341f2025-03-31Warnings, Adverse reactionsExact identifier
rxcui: 995218
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepackd03fdfd0-5dbd-40fe-a6e3-082a47751c2c2025-03-31Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
ALEX MD PHD Sheer Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC8f64c4fa-92ee-4af0-ab1b-6c3673f9a6222025-03-28WarningsExact identifier
unii: 15FIX9V2JP
ALEX MD PHD Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC93873c34-5c72-43c8-b6c2-c65b596191d72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
City Skin Age Defense Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMurad, LLCf8c572a2-b4bc-49e9-95df-359f05bd69b72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products BM238SANTONINE, CINA, SILICEA, INDIGO, AMBROSIA, CUCCURBITA CIT, CUCCURBITA PEPBestmade Natural Products298fb9e2-3f98-01e6-e063-6294a90a7aaf2025-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral MediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe17dc640-30e9-441b-a212-ef1508af79442025-03-25WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products Silicea 6x Lactose-freeSILICEA ORGANIC CANE SUGARBestmade Natural Products2991ecbf-925e-00f3-e063-6294a90a37bf2025-03-25WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM60CIMICIFUGAD6, DROSERAD6, FORMICA RUFAD6, FULIGOD6, INULA HELD6, KALI MURD6, LAPIS ALBUSD6, SILICEAD6Bestmade Natural Products29912fb7-8712-18d9-e063-6394a90a82f72025-03-25WarningsExact identifier
unii: ETJ7Z6XBU4
it cosmetics Your Skin But Better CC Plus Oil Free Matte Poreless Finish Full Coverage Broad Spectrum SPF 40 Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb7d184fb-4a9a-4720-9b00-bf0caa257a8c2025-03-25WarningsExact identifier
unii: 15FIX9V2JP
DOMINAS DARK SPOT TINTED SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H CO., LTD.2b6140cf-7e34-1658-e063-6394a90a32712025-03-24WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01273e8c-aef0-d800-e063-6294a90abd492025-03-23WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01221d57-9eec-7e77-e063-6394a90a60422025-03-23WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD0ce809a1-45fb-9d4d-e063-6294a90a26a22025-03-23WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products SiliceaSILICEABestmade Natural Productse9eadb4e-659b-dcae-e053-2995a90a0db72025-03-21WarningsExact identifier
unii: ETJ7Z6XBU4
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs0c687cbe-ce40-4bc0-b880-5166b5be7a802025-03-20Warnings, Adverse reactionsExact identifier
rxcui: 995218
rxcui: 995281
rxcui: 995258
unii: 76755771U3
Natural Eyes Stye Relief Fast Dissolving TablesAPIS MELLIFICA, CARBONEUM SULPHURATUM, PULSATILLA, SEPIA, SILICEATRP Company30a5435b-32b0-807d-e063-6294a90a84da2025-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
EMF Protect and BalanceALFALFA, 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 HISPANA, X-RAY, YTTERBIUM OXIDEDeseret Biologicals, Inc.00a2c1c7-2c04-4c71-9276-24ba87288d612025-03-17WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.