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 4 of 19 · 364 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDECoupler LLC508848a5-017c-dd3e-e063-6294a90a456b2026-04-28Warnings, Adverse reactionsExact identifier
unii: 76755771U3
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDERedpharm Drug4fb58637-dc30-c4dd-e063-6394a90a8bbe2026-04-18Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4cd84205-6a33-db48-e063-6394a90a91822026-04-16Warnings, Adverse reactionsExact identifier
unii: 76755771U3
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: QTT17582CB
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEKesin Pharma4b094d1b-97b2-6ca6-e063-6294a90a24372026-03-10Warnings, Adverse reactionsExact identifier
unii: 76755771U3
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
unii: LKG8494WBH
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAurobindo Pharma Limited9de2de56-614f-4294-8794-d30758cf5f702026-03-03Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack56b49e5c-bb8a-46cd-873c-3c743d1653a42026-02-17Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.71eea118-395c-4559-aed5-900b635674b82026-02-12Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions1350964e-663e-4a50-8c4c-cda371a694a02026-02-04Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS19fe26a9-eb1a-4c5b-a5e4-65223ee56ad12026-02-02Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.6ad55cd1-a284-4c3d-aa90-653704afdb752026-01-30Warnings, Adverse reactionsExact identifier
unii: 76755771U3
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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