FDA.reportPublic FDA data

NDC 0049-5610 - Atarax

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
0049-5610
Package NDCs from labels
0049-5610-66, 0049-5610-73
Manufacturer
Roerig
Effective date
2006-06-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Atarax - RoerigRoerig2006-06-20HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0049-5610-66Atarax100 in 1 BOTTLETABLET1001
0049-5610-73Atarax500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-5610ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]12 package rows20060921_7EAF5043-5C73-47AF-904B-8E1FAE02AF2E.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
hydroxyzine hydrochlorideACTIVE INGREDIENT76755771U3ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
hydroxyzineACTIVE MOIETY30S50YM8OGATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
acaciaINACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
alcoholINACTIVE INGREDIENT3K9958V90MATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
alginic acidINACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
Blue 1INACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
carnauba waxINACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
dibasic calcium phosphateINACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
gelatinINACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
lactoseINACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
mentholINACTIVE INGREDIENT80R52064AQATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
peppermint oilINACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
polyethylene glycolINACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
precipitated calcium carbonateINACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
Red 3INACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
shellacINACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
spearmint oilINACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
starchINACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
sucroseINACTIVE INGREDIENTC151H8M554ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
talcINACTIVE INGREDIENT7SEV7J4R1UATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
velo dark greenINACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
velo yellowINACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
waterINACTIVE INGREDIENT059QF0KO0RATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
white waxINACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1
Yellow 6 LakeINACTIVE INGREDIENTATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]1

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 7 of 8 · 141 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionse83de74d-b2e0-45c5-b072-170a96216d3a2024-01-04Warnings, Adverse reactionsExact identifier
rxcui: 995258
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions80e60583-76d3-4e65-8581-4cdaff7cd1c12023-10-23Warnings, Adverse reactionsExact identifier
rxcui: 995258
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEChartwell RX, LLC4590101d-7fb2-478b-acc5-bc9bdbb38ca92023-10-11Warnings, Adverse reactionsExact identifier
rxcui: 995241
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd618157e-f43f-4b31-ba5b-8a13a94885bc2023-09-18Warnings, Adverse reactionsExact identifier
rxcui: 995258
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions2e346b0c-9407-4346-82c2-d9755cbcd8b02023-09-11Warnings, Adverse reactionsExact identifier
rxcui: 995258
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions49ee4ecf-b2c0-4301-89da-111e4d8531682023-09-11Warnings, Adverse reactionsExact identifier
rxcui: 995258
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions46266803-0905-4ae2-9d17-dbf4c2a081812023-09-07Warnings, Adverse reactionsExact identifier
rxcui: 995258
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions3d5d3ebf-e57e-4ed1-be97-d4b299fb738d2023-09-07Warnings, Adverse reactionsExact identifier
rxcui: 995258
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions3d2e63c6-993c-42b9-91a0-616246789a7b2023-09-07Warnings, Adverse reactionsExact identifier
rxcui: 995258
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions92d8cc57-7e3a-4217-9160-e1b56db5570e2023-05-09Warnings, Adverse reactionsExact identifier
rxcui: 995258
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDELannett Company, Inc.a4fb61ae-aad6-4bd6-83fc-8b227f175df92023-01-24Warnings, Adverse reactionsExact identifier
rxcui: 995241
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC8e954579-b0f5-4ce3-bade-0b9b972f6f8b2023-01-23Warnings, Adverse reactionsExact identifier
rxcui: 995258
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEKVK-Tech, Inc.adc4cb73-77c6-48ff-aaf2-b3568d53de1f2023-01-04Warnings, Adverse reactionsExact identifier
rxcui: 995218
rxcui: 995281
rxcui: 995258
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDECamber Pharmaceuticals, Inc.f7e527fe-2f67-45ad-a3ec-146ead8195142022-11-24Warnings, Adverse reactionsExact identifier
rxcui: 995218
rxcui: 995281
rxcui: 995258
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEProficient Rx LP3edfac5c-a08b-4270-a343-9b2dc10a4a6e2022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 995281
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEProficient Rx LP642ff329-c551-44f0-b340-49313db868c52022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 995281
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEProficient Rx LPdaefb617-209a-428b-9567-adc5880fa65c2022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 995258
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEProficient Rx LPbcddc5ce-6cfb-4a09-8e6c-c956b65e31882022-10-01Warnings, Adverse reactionsExact identifier
rxcui: 995241
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEProficient Rx LP73993c7e-acd7-4835-be03-f8274a15955b2022-06-01Warnings, Adverse reactionsExact identifier
rxcui: 995281
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEProficient Rx LP2da6dd2f-90e2-464a-ad2a-292575cb04282022-05-02Warnings, Adverse reactionsExact identifier
rxcui: 995218

Reported adverse events (FAERS/openFDA)#

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