FDA.reportPublic FDA data

NDC 5011-308 - 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
5011-308
Manufacturer
RedPharm Drug Inc. | Pliva Inc.
Effective date
2011-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYDROXYZINE HYDROCHLORIDE TABLETS USPRedPharm Drug Inc. | Pliva Inc.2011-07-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]1

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 67 of 136 · 2,716 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e l f Camo Semi Matte CC SPF 30 Light 250 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.0b1c20e6-9d98-4b69-8fe0-ac5e9f2b9b2c2025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 370 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.b8d4862e-2671-4b85-8338-f935e0d0194f2025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 310 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8d53abee-73bc-4268-b08d-0c196ff4d8522025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 375 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.1de296f5-276b-4e8f-8db2-78ea01965c4a2025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 610 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.75543b93-8ed9-4c7b-9fcf-99745df5a1942025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 620 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.798eecb3-ff6e-46d1-9053-b40e9cd02e5c2025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 640 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.cbf949b3-e640-48eb-acf6-fccd6f2588652025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 650 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.b8bfad36-54b7-42f3-bb5b-5eda1a10f0212025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 660 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.853100ea-a9dc-43eb-9715-125b543d2be02025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Tan 400 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.e4f2b579-4886-4e20-a527-c033e9d60bf52025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Tan 460 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.49255019-fa24-4667-b527-ef7189a51f122025-10-31WarningsExact identifier
unii: 15FIX9V2JP
HydroxyzineHYDROXYZINEHenry Schein, Inc.851e7439-bb0a-4a09-9279-e3c33bff89652025-10-31Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Clove Hill Tinted Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCeb2ff5a7-384f-4379-b149-47c1c8c2291d2025-10-30WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCa37db64d-8b79-40f4-843f-f38949c5b9d22025-10-30WarningsExact identifier
unii: 15FIX9V2JP
MOOYAM Dark Skin SunscreenSUNSCREENGuangdong Bisutang Biotechnology Co., LTD4246e9f1-1c51-d888-e063-6394a90abda02025-10-29WarningsExact identifier
unii: 15FIX9V2JP
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLC311b270f-b9e2-2374-e063-6294a90af5812025-10-29WarningsExact identifier
unii: 15FIX9V2JP
Perricone MD Neuropeptide Restorative Neck and Chest Therapy Broad Spectrum SPF 25TITANIUM DIOXIDETHG Beauty USA LLC23f4cf41-0eed-2df3-e063-6294a90ad4022025-10-28WarningsExact identifier
unii: 15FIX9V2JP
PERRICONE MD VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30TITANIUM DIOXIDETHG Beauty USA LLC397b4338-fec8-5228-e063-6394a90ad97d2025-10-23WarningsExact identifier
unii: 15FIX9V2JP
Perricone MD HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer Broad Spectrum SPF 30TITANIUM DIOXIDETHG Beauty USA LLC38c80373-1d5a-c7f4-e063-6294a90aa9c22025-10-23WarningsExact identifier
unii: 15FIX9V2JP
Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35ZINC OXIDE, TITANIUM DIOXIDETHG Beauty USA LLC254b4692-a459-6119-e063-6394a90a0a602025-10-23WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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