FDA.reportPublic FDA data

NDC 17856-0507-2 - 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
17856-0507
Requested NDC
17856-0507-2
Package NDCs from labels
17856-0507-2, 17856-0507-1
Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2025-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydroxyzine Hydrochloride - ATLANTIC BIOLOGICALS CORP.ATLANTIC BIOLOGICALS CORP.2025-05-12HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0507-12024-05-08C16284748780-11030e365-5e4e-111a-e063-dadaa90a10e2HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP) 10 mg per 5 mL Rx only
17856-0507-12024-01-30C16284748780-11030e365-5e4e-111a-e063-dadaa90a10e2HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP) 10 mg per 5 mL Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0507-1Hydroxyzine Hydrochloride72 in 1 BOX, UNIT-DOSESOLUTION725
17856-0507-2Hydroxyzine Hydrochloride5 mL in 1 CUP, UNIT-DOSESOLUTION55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0507HYDROXYZINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]5Current NDC, Legacy NDC, 2 package rows20250514_a2fbc502-6ca3-4304-9069-b7249c9d9489.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0507-1ML - Milliliter17856-05073e126985-ac18-407d-9c5d-91db89fee21612023-09-05

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 17 of 25 · 488 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.a8af7dd0-fef8-5c39-e053-2a95a90ae11a2024-07-17Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAmerican Health Packaging58fa9952-c8ab-4ebb-a073-15cc45f4832a2024-07-16Adverse reactionsExact identifier
unii: 1Q73Q2JULR
unii: XF417D3PSL
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1bf88820-e5f9-06e7-e063-6294a90a80ad2024-06-28Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.714a26a1-371f-ef23-e053-2a95a90a6af62024-06-10Warnings, Adverse reactionsExact identifier
unii: 76755771U3
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack4b8614d9-335c-4141-aaed-445c604ba08c2024-06-10Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAmerican Regent, Inc.8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a2024-06-05Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC19b08f92-da63-021f-e063-6394a90a16e22024-05-30Warnings, Adverse reactionsExact identifier
unii: 76755771U3
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst16a63845-6619-293b-e063-6394a90a0a5c2024-05-28Warnings, Adverse reactionsExact identifier
unii: 76755771U3
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d5dea47-5103-21a3-e053-2995a90aee782024-05-20WarningsExact identifier
unii: C151H8M554
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLC138ec5c1-bb06-2a82-e063-6394a90ab42b2024-05-17Warnings, Adverse reactionsExact identifier
unii: 76755771U3
IntimateNATRUM CARBONICUM, SACCHARUM OFFICINALE, LITHIUM CARBONICUM, PLACENTA TOTALIS SUIS, LAC CANINUM, ANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, GERMANIUM METALLICUM, HELLEBORUS NIGER, MAGNESIA OXYDATA, RHUS GLABRA, STRAMONIUM, THUJA OCCIDENTALIS, DNA (HUMAN), OXYTOCIN, HYDROGEN, NEON, LAC MATERNA HUMANUMDeseret Biologicals, Inc.ca0447c1-606e-443a-b789-7d65143fec282024-05-13WarningsExact identifier
unii: C151H8M554
Sodium Phenylacetate and Sodium BenzoateSODIUM PHENYLACETATE AND SODIUM BENZOATEFOSUN PHARMA USA INCcee1e9a2-bbe5-2419-e053-2a95a90ac3ef2024-05-09Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEProficient Rx LPd79be126-39cd-4dbb-ad88-0e4c18109dda2024-05-01Warnings, Adverse reactionsExact identifier
unii: 76755771U3
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREAS SUIS, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.83249aee-f58b-442d-9187-6de0cf070e4d2024-04-29WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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