FDA.reportPublic FDA data

NDC 0517-5602-01 - Hydroxyzine

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
0517-5602
Requested NDC
0517-5602-01
Package NDCs from labels
0517-5602-01, 0517-5602-25
Manufacturer
Henry Schein, Inc.
Effective date
2025-10-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydroxyzine HCL 50mg/mL Injection, USP 2 mL Single Dose VialHenry Schein, Inc.2025-10-31HUMAN PRESCRIPTION DRUG LABEL
Hydroxyzine Hydrochloride Injection, USPAmerican Regent, Inc.2024-06-05HUMAN PRESCRIPTION DRUG LABEL
Hydroxyzine - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2022-12-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-5602-01Hydroxyzine Hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION218
0517-5602-25Hydroxyzine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION2518

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-5602HYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]17Current NDC, Legacy NDC, 2 package rows20240607_8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-5602-01ML - Milliliter0517-560279a59473-e8ea-4836-8d48-a3817f1a890012025-10-14
0517-5602-25ML - Milliliter0517-5602069c5564-1388-4cbc-9656-b77e22ea257a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]8
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]8
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]8
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]8
WATERINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]8
Hydroxyzine HydrochlorideACTIVE INGREDIENT76755771U3HYDROXYZINE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]2
HydroxyzineACTIVE MOIETY30S50YM8OGHYDROXYZINE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]2

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 8 of 19 · 364 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEDirect Rxd956063a-ef48-faca-e053-2995a90a02912025-10-06Exact identifier
unii: 76755771U3
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAmerican Health Packagingfc148d96-b868-4e45-b7d2-977faf4310492025-09-15Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack93d117dd-e2bf-4daa-abe3-d4fefed3313c2025-09-11Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack3f90259a-a684-498f-8963-d02eaba2e9db2025-09-08Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack9c2c05e0-b123-4ddf-8b07-6bb3ca0678b52025-09-08Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2b05bd0e-af57-4e74-92f8-a4311330142f2025-08-18Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.214b3f14-2f6c-4f36-b7a6-e0b1f820e3a72025-08-18Warnings, Adverse reactionsExact identifier
unii: 76755771U3
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDERising Pharma Holdings, Inc.6a1a48ac-8ad5-4363-b298-d9825ae2a4482025-08-14Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.80309ec1-e5d5-4454-b8ce-67d7e6805e442025-07-31Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDE ORALBionpharma Inc.39f93633-000e-6c3f-e063-6394a90a5a0b2025-07-15Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ca015a35-1f94-4f92-9143-3f149982d3162025-07-15Warnings, Adverse reactionsExact identifier
unii: 76755771U3

Reported adverse events (FAERS/openFDA)#

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