FDA.reportPublic FDA data

NDC 16714-082-04 - 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
16714-082
Requested NDC
16714-082-04
Package NDCs from labels
16714-082-10, 16714-082-11, 16714-082-12, 16714-082-04
Manufacturer
Northstar RxLLC | Piramal Pharma Limited
Effective date
2025-12-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HydrOXYzine Hydrochloride - Northstar RxLLC | Piramal Pharma LimitedNorthstar RxLLC | Piramal Pharma Limited2025-12-23Human Prescription Drug Label
Rx OnlyNuCare Pharmaceuticals,Inc.2025-11-20HUMAN PRESCRIPTION DRUG LABEL
HydrOXYzine Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2025-07-09Human Prescription Drug Label
Rx OnlyNuCare Pharmaceuticals,Inc.2025-02-05HUMAN PRESCRIPTION DRUG LABEL
Rx OnlyMcKesson Corporation dba SKY Packaging | Legacy Pharmaceutical Packaging, LLC2024-12-26HUMAN PRESCRIPTION DRUG LABEL
HydrOXYzine Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2023-09-07Human Prescription Drug Label
HydrOXYzine Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2023-09-07Human Prescription Drug Label
HydrOXYzine Hydrochloride - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2023-01-23Human Prescription Drug Label
HydrOXYzine Hydrochloride - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2021-01-14HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-082-10HydrOXYzine Hydrochloride100 in 1 BOTTLETABLET10019
16714-082-11HydrOXYzine Hydrochloride500 in 1 BOTTLETABLET50019
16714-082-12HydrOXYzine Hydrochloride1000 in 1 BOTTLETABLET100019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-082HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]18Current NDC, Legacy NDC, 3 package rows20250206_8e5fce17-936e-46ea-a969-518c952c2091.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-082-04EA - Each16714-082da8db88e-e5d7-4f30-8258-be17f1111a8212012-07-24
16714-082-05EA - Each16714-0827f3cf018-8c9b-4d7c-9859-6606747dfb3412012-07-24
16714-082-06EA - Each16714-082452fbb51-342a-45c5-82ee-7dd64e6d990412012-07-24
16714-082-10EA - Each16714-0828abc36ef-c58f-463d-8842-61daa04d62a912013-10-17
16714-082-11EA - Each16714-08285511cb8-8dbe-4016-89b7-205295aab37612013-10-17
16714-082-12EA - Each16714-082a9e82ee8-4558-4c67-a40b-bf0bcb93eb7e12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrOXYzine HydrochlorideACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
hydrOXYzineACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET [NORTHSTAR RXLLC]10
HydrOXYzine HydrochlorideACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
hydrOXYzineACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3

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 1 of 146 · 2,919 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.58d99cf6-2319-410b-b8be-de9c304541b62026-09-08Warnings, Adverse reactionsExact identifier
application number: ANDA040840
rxcui: 995218
unii: 76755771U3
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDECoupler LLC5a586fc0-e4e0-5621-e063-6294a90a222b2026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 995281
unii: 76755771U3
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.8f41912e-12ce-4174-a0fb-cfb4888d8d582026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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