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 97 of 138 · 2,750 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Sunscreen Cream SPF 30 4-Deep AmberTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley5599922a-b020-477c-a44c-1db42ec5756a2024-12-10WarningsExact identifier
unii: 15FIX9V2JP
Tinted Sunscreen SPF 30 1-NaturalTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisleyb3d53a10-2647-492a-a05f-b97c3f716aa82024-12-10WarningsExact identifier
unii: 15FIX9V2JP
Tinted Sunscreen SPF 30 2-GoldenTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley389cbce6-552c-4633-babd-7b672632f0b92024-12-10WarningsExact identifier
unii: 15FIX9V2JP
Prevention Daily Tinted Moisturizer SPF 30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labsed883d63-777c-e924-e053-2995a90a162a2024-12-09WarningsExact identifier
unii: 15FIX9V2JP
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen MahoganyZINC OXIDE AND TITANIUM DIOXIDEAllure Labsdcba05ff-7a68-c5c0-e053-2a95a90a61292024-12-09WarningsExact identifier
unii: 15FIX9V2JP
MD Restoring daily Defense Moisturizer SPF 50ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs Inceb8e7109-b5eb-5cc1-e053-2995a90a486f2024-12-09WarningsExact identifier
unii: 15FIX9V2JP
Quench and Protect Hydrating SPF30ZINC DIOXIDE AND TITANIUM DIOXIDEAllure Labs.039e50c1-7b3d-d392-e063-6394a90a4b3c2024-12-09WarningsExact identifier
unii: 15FIX9V2JP
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDESunrise Pharmaceutical, Inc.94561525-a565-4193-b64d-e1459ab056782024-12-09Warnings, Adverse reactionsExact identifier
application number: ANDA207121
rxcui: 995218
rxcui: 995281
rxcui: 995258
unii: 76755771U3
Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50TITANIUM DIOXIDE, ZINC OXIDEBeautcella Inc.bad942d8-04da-31d2-e053-2a95a90a92752024-12-06WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB Cream SPF42 (No. 25)ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.604e7a49-7986-11ee-e053-2a91aa0a1bee2024-12-05WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB No 27ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.c4e16cec-c7db-4e5e-9d05-5d7afdb790912024-12-05WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB SPF42 No29OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDEAble C&C Co., Ltd.3fc90114-4cdf-273e-e054-00144ff8d46c2024-12-05WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB No 31ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.95862d15-d977-7276-e053-2995a90ab6902024-12-05WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB Cream SPF42 No. 25ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.9c6f48b1-007b-434f-b756-242e3390e9b72024-12-05WarningsExact identifier
unii: 15FIX9V2JP
MISSHA ALL AROUND VITA C SUNSCREENZINC OXIDE, HOMOSALATE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDEAble C&C Co., Ltd.1a7ec673-328a-8924-e063-6294a90a2f3d2024-12-05WarningsExact identifier
unii: 15FIX9V2JP
EGF FGF DNA UV SHIELDETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATEDermaesthetics Inc.13e2630d-9915-4287-91fd-deb6721501312024-12-04WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB No 13ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.95846b5e-5b72-26bc-e053-2a95a90ae0f72024-12-04WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB No 21ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.9585d3d2-806c-36e3-e053-2a95a90a28fa2024-12-04WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB SPF42 No21OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDEAble C&C Co., Ltd.3d196cf3-eddd-21d7-e054-00144ff88e882024-12-04WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB No 23ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.6a81522e-f4d9-4013-8563-f50f01ff63262024-12-04WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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