FDA.reportPublic FDA data

NDC 81033-031-05 - 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
81033-031
Requested NDC
81033-031-05
Package NDCs from labels
81033-031-05, 81033-031-44, 81033-031-12, 81033-031-45
Manufacturer
Kesin Pharma
Effective date
2026-03-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydroxyzine Hydrochloride - Kesin PharmaKesin Pharma2026-03-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-031-05Hydroxyzine Hydrochloride5 mL in 1 CUP, UNIT-DOSESOLUTION52
81033-031-12Hydroxyzine Hydrochloride12.5 mL in 1 CUP, UNIT-DOSESOLUTION12.52
81033-031-44Hydroxyzine Hydrochloride40 in 1 CARTONSOLUTION402
81033-031-45Hydroxyzine Hydrochloride40 in 1 CARTONSOLUTION402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-031-05ML - Milliliter81033-031d792c426-65f3-4a59-bc7c-da089105f7be12026-04-20
81033-031-12ML - Milliliter81033-031d75e6d7f-abba-4225-9f70-bb18b58d6ea312026-04-20
81033-031-44ML - Milliliter81033-031c0a022c7-f081-46f7-81ce-460abec27ed912026-04-20
81033-031-45ML - Milliliter81033-0311f586e30-cc21-4d11-91f3-2897b6cb341812026-04-20

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 24 · 469 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATER J General Corporationdbb0d067-71f0-45e4-bc98-548cf4a90b3a2025-11-17WarningsExact identifier
unii: XF417D3PSL
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.0de7a377-7a8f-4119-b172-1eadb4b7e1be2025-11-11Warnings, Adverse reactionsExact identifier
rxcui: 995241
unii: 76755771U3
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsa9a133e6-efce-4bdb-9335-49c74e57fafe2025-11-01Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEHenry Schein, Inc.7279ad5a-0a49-432d-8fa2-17e4c6ecbadc2025-10-31Warnings, Adverse reactionsExact identifier
unii: 76755771U3
HydroxyzineHYDROXYZINEHenry Schein, Inc.851e7439-bb0a-4a09-9279-e3c33bff89652025-10-31Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: C151H8M554
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7165a30c-09e4-4ca1-8548-bf71998ba12f2025-10-20Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Walgreens Antacid Pain Relief Extra StrengthASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreensb60df498-07db-500b-e053-2a95a90aff6a2025-10-17WarningsExact identifier
unii: XF417D3PSL
Equate Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalmart6271b34b-55a0-40a8-e053-2a91aa0acb222025-10-17Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.4789b7ae-314c-43c0-ad33-92ff50085f272025-10-17Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1a3e389f-391d-4f37-9e34-ce3c6f5fe8c12025-10-17Warnings, Adverse reactionsExact identifier
unii: 76755771U3

Reported adverse events (FAERS/openFDA)#

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