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 18 of 139 · 2,780 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lower GI and Probiotic RestorationAETHUSA 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-d0eed9a9ff932026-03-10WarningsExact identifier
unii: ETJ7Z6XBU4
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEKesin Pharma4b094d1b-97b2-6ca6-e063-6294a90a24372026-03-10Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Constitutional EnhancerACONITUM 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-39f48a8f13dd2026-03-10WarningsExact identifier
unii: ETJ7Z6XBU4
VermiclearGRANATUM, 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 MARUMEnergique, Inc.f7cf3edd-2451-4a4f-b1f2-1b3db2bb4dca2026-03-09WarningsExact identifier
unii: ETJ7Z6XBU4
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: 3NXW29V3WO
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact identifier
unii: 15FIX9V2JP
OsteoplexEQUISETUM 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-7f1a7f1a849b2026-03-05WarningsExact identifier
unii: ETJ7Z6XBU4
Respiforce A-HPARSENICUM ALBUM, BELLADONNA, IPECACUANHA, KALI CARBONICUM, LOBELIA INFLATA, NATRUM SULPHURICUM, SILICEABioActive Nutritional, Inc.ebf5f0c7-e7a4-45fe-acfd-52c46a8d789c2026-03-05WarningsExact identifier
unii: ETJ7Z6XBU4
Sinus Defense 2.0LAC 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 NOSODEMicro Balance Health Products LLC560f84f6-2544-4ba8-8236-a95906eb7d972026-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Snore ControlBROMIUM, 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-81ffe0e79d102026-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAurobindo Pharma Limited9de2de56-614f-4294-8794-d30758cf5f702026-03-03Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
911 Adrenal Burnout and FatigueACETICUM 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-02e79d1be7562026-02-26WarningsExact identifier
unii: ETJ7Z6XBU4
TIBENA EVERY DAY REAL SUN BLOCKTITANIUM DIOXIDE, ZINC OXIDEKONAD CO LTD211c9930-4f91-cf8f-e063-6394a90a97b32026-02-26WarningsExact identifier
unii: 15FIX9V2JP
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION MATTE M B10TITANIUM DIOXIDEShiseido Americas Corporation54f8210f-4934-4ada-89c3-aa89e7a092602026-02-26WarningsExact identifier
unii: 15FIX9V2JP
ResilienceCEREBRUM SUIS, HYPOTHALAMUS SUIS, HYPOPHYSIS SUIS, SEROTONIN (HYDROCHLORIDE), NPY (NEUROPEPTIDE Y), CALCAREA CARBONICA, SILICEA, VERATRUM ALBUM, BLATTA AMERICANA, CACAO, DIOSPYROS KAKI, FORMICA RUFA, PALOONDO, SULPHUR, TAXUS BACCATA, TELA ARANEAE, SALIX VITELLINA, FLOSDeseret Biologicals, Inc.3aa6c1e7-2bd9-4c2d-bfd4-63ffb7c62e9c2026-02-26WarningsExact identifier
unii: ETJ7Z6XBU4
Quantum HarmonyBLATTA AMERICANA, CEREBRUM SUIS, CACAO, COLUMBUS PALUMBA, HEART (SUIS), DIOSPYROS KAKI, FORMICA RUFA, HYPOTHALAMUS SUIS, HYPOPHYSIS SUIS, PALOONDO, NPY (NEUROPEPTIDE Y), SEROTONIN (HYDROCHLORIDE), SILICEA, SULPHUR, VERATRUM ALBUM, SALIX VITELLINA, FLOSDeseret Biologicals, Inc.1742ac50-ec6e-4261-a0b8-791b893742ef2026-02-25WarningsExact identifier
unii: ETJ7Z6XBU4
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORYOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc05cef12-a6a7-4682-9357-6d77f4ca32672026-02-25WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE RADIANT FOUNDATION N M I10OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation3be1fe06-bd3b-4078-bee9-d3caf8d068ff2026-02-25WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact identifier
unii: 15FIX9V2JP
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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