FDA.reportPublic FDA data

NDC 0049-5590 - 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
0049-5590
Package NDCs from labels
0049-5590-93
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
0049-5590-93Atarax473 mL in 1 BOTTLESYRUP4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-5590ATARAX (HYDROXYZINE HYDROCHLORIDE) TABLET ATARAX (HYDROXYZINE HYDROCHLORIDE) SYRUP [ROERIG]11 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 2 of 8 · 141 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDESaptalis Pharmaceuticals, LLC.9ab23881-334c-474d-9d93-25ea225548dc2026-06-16Warnings, Adverse reactionsExact identifier
rxcui: 995241
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy1767a886-ec92-39fb-e063-6294a90a12492026-06-03Warnings, Adverse reactionsExact identifier
rxcui: 995258
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.534a6a49-23df-d65e-e063-6294a90a1a122026-06-02Warnings, Adverse reactionsExact identifier
rxcui: 995258
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.52fb8616-7d4e-9c37-e063-6294a90a11122026-05-29Warnings, Adverse reactionsExact identifier
rxcui: 995281
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDECoupler LLC519e54e0-a613-e7b3-e063-6294a90a44522026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 995258
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.413a39ce-98d6-40f5-9048-ad464e98de442026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 995218
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.7edd582c-039c-4bdc-bf8a-61eac8a5a9a02026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 995258
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEPreferred Pharmaceuticals Incl63fdf791-1a58-45ba-8ef2-15b80bb24f232026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 995258
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEProficient Rx LPca843456-0c93-41e8-9bbc-9cd92447f0922026-05-01Warnings, Adverse reactionsExact identifier
rxcui: 995218
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDECoupler LLC508848a5-017c-dd3e-e063-6294a90a456b2026-04-28Warnings, Adverse reactionsExact identifier
rxcui: 995258
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDERedpharm Drug4fb58637-dc30-c4dd-e063-6394a90a8bbe2026-04-18Warnings, Adverse reactionsExact identifier
rxcui: 995281
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4cd84205-6a33-db48-e063-6394a90a91822026-04-16Warnings, Adverse reactionsExact identifier
rxcui: 995218
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEKesin Pharma4b094d1b-97b2-6ca6-e063-6294a90a24372026-03-10Warnings, Adverse reactionsExact identifier
rxcui: 995241
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAurobindo Pharma Limited9de2de56-614f-4294-8794-d30758cf5f702026-03-03Warnings, Adverse reactionsExact identifier
rxcui: 995218
rxcui: 995281
rxcui: 995258
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack56b49e5c-bb8a-46cd-873c-3c743d1653a42026-02-17Warnings, Adverse reactionsExact identifier
rxcui: 995218
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.71eea118-395c-4559-aed5-900b635674b82026-02-12Warnings, Adverse reactionsExact identifier
rxcui: 995218
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions1350964e-663e-4a50-8c4c-cda371a694a02026-02-04Warnings, Adverse reactionsExact identifier
rxcui: 995281
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS19fe26a9-eb1a-4c5b-a5e4-65223ee56ad12026-02-02Warnings, Adverse reactionsExact identifier
rxcui: 995218
rxcui: 995281
rxcui: 995258
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.6ad55cd1-a284-4c3d-aa90-653704afdb752026-01-30Warnings, Adverse reactionsExact identifier
rxcui: 995258
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDENorthwind Health Company, LLCf2b3d10f-2599-5b71-e053-2a95a90a54bb2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 995281

Reported adverse events (FAERS/openFDA)#

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