FDA.reportPublic FDA data

NDC 55154-2148-00 - 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
55154-2148
Requested NDC
55154-2148-00
Package NDCs from labels
55154-2148-0, 55154-2148-00
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-07-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydroxyzine Hydrochloride - Cardinal Health 107, LLCCardinal Health 107, LLC2026-07-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-2148-0Hydroxyzine Hydrochloride10 in 1 BAGTABLET, FILM COATED101
55154-2148-0Hydroxyzine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED11

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 4 of 138 · 2,749 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEAPOZEAL PHARMACEUTICALS INC87d4bbff-0498-4c26-86cb-7ce173afa0b62026-07-21Warnings, Adverse reactionsExact identifier
unii: 76755771U3
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsbe6a2f09-c0f3-44e2-aac3-37e3702b93f02026-07-21Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDECardinal Health 107, LLCb4d274ce-d616-4835-80ce-76270524ed362026-07-20Warnings, Adverse reactionsExact identifier
application number: ANDA088618
ndc (package): 55154-2148-0
ndc (product): 55154-2148
ndc11 (package): 55154214800
rxcui: 995258
spl id: 1990038a-5c92-4ccf-8b76-b0da11e5031e
spl set id: b4d274ce-d616-4835-80ce-76270524ed36
unii: 76755771U3
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEMajor Pharmaceuticals7f76580c-96a0-4b56-8986-ff5488bb98692026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 995218
rxcui: 995258
unii: 76755771U3
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.bb4a7d22-2f42-4e9f-bf98-cee43ed14d502026-07-15Warnings, Adverse reactionsExact identifier
unii: 76755771U3
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEPreferred Pharmaceuticals Incc8b441bf-a03e-47b3-8f06-c347f5ca4b702026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 995218
unii: 76755771U3
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.b6189074-e199-4f58-a78d-c04f131c13d92026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC5648abce-f20e-717c-e063-6294a90a88ac2026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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