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 3 of 24 · 469 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEUnit Dose Solutions, Inc.5506e802-0efc-a845-e063-6394a90aad0e2026-06-24Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAmerican Health Packaging47bda4fe-ddb7-4140-900a-970373cc7acc2026-06-23Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepackf84e3365-57d2-4904-9275-96600f8d74c72026-06-22Warnings, Adverse reactionsExact identifier
unii: 76755771U3
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDESaptalis Pharmaceuticals, LLC.9ab23881-334c-474d-9d93-25ea225548dc2026-06-16Warnings, Adverse reactionsExact identifier
rxcui: 995241
unii: 76755771U3
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: XF417D3PSL
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATECardinal Health 107, LLCb3d5225c-0ee4-481e-b9ec-bc5e1321096d2026-06-12Adverse reactionsExact identifier
unii: XF417D3PSL
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy1767a886-ec92-39fb-e063-6294a90a12492026-06-03Warnings, Adverse reactionsExact identifier
unii: 76755771U3
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.534a6a49-23df-d65e-e063-6294a90a1a122026-06-02Warnings, Adverse reactionsExact identifier
unii: 76755771U3
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.52fb8616-7d4e-9c37-e063-6294a90a11122026-05-29Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
unii: XF417D3PSL
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDECoupler LLC519e54e0-a613-e7b3-e063-6294a90a44522026-05-12Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.413a39ce-98d6-40f5-9048-ad464e98de442026-05-11Warnings, Adverse reactionsExact identifier
unii: 76755771U3
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.7edd582c-039c-4bdc-bf8a-61eac8a5a9a02026-05-11Warnings, Adverse reactionsExact identifier
unii: 76755771U3

Reported adverse events (FAERS/openFDA)#

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