FDA.reportPublic FDA data

NDC 23155-500-18 - 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
23155-500
Requested NDC
23155-500-18
Package NDCs from labels
23155-500-05, 23155-500-10, 23155-500-01, 23155-500-18
Manufacturer
Coupler LLC | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
Effective date
2026-08-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rx onlyCoupler LLC | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.2026-08-04HUMAN PRESCRIPTION DRUG LABEL
Hydroxyzine hydrochloride - Major PharmaceuticalsMajor Pharmaceuticals2026-07-15HUMAN PRESCRIPTION DRUG LABEL
Hydroxyzine hydrochloride - Preferred Pharmaceuticals IncPreferred Pharmaceuticals Inc2026-07-15HUMAN PRESCRIPTION DRUG LABEL
Rx onlyNuCare Pharmaceuticals, Inc.2026-04-16HUMAN PRESCRIPTION DRUG LABEL
Rx onlyREMEDYREPACK INC.2026-02-12HUMAN PRESCRIPTION DRUG LABEL
Hydroxyzine hydrochloride - Northwind Health Company, LLCNorthwind Health Company, LLC2025-12-26HUMAN PRESCRIPTION DRUG LABEL
HYDROXYZINE HYDROCHLORIDE - Direct Rx | DirectRxDirect Rx | DirectRx2025-10-06HUMAN PRESCRIPTION DRUG LABEL
Hydroxyzine Hydrochloride Tablets. Rx onlyGolden State Medical Supply, Inc.2025-07-02HUMAN PRESCRIPTION DRUG LABEL
Rx onlyHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | Emcure Pharmaceuticals Limited | CorePharma, LLC2025-05-16HUMAN PRESCRIPTION DRUG LABEL
Hydroxyzine hydrochloride - A-S Medication SolutionsA-S Medication Solutions2025-05-15HUMAN PRESCRIPTION DRUG LABEL
Hydroxyzine hydrochloride - NCS HealthCare of KY, LLC dba Vangard LabsNCS HealthCare of KY, LLC dba Vangard Labs2025-03-20HUMAN PRESCRIPTION DRUG LABEL
Hydroxyzine hydrochloride - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2024-12-17HUMAN PRESCRIPTION DRUG LABEL
Hydroxyzine hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2024-04-05HUMAN PRESCRIPTION DRUG LABEL
Hydroxyzine hydrochloride - Proficient Rx LPProficient Rx LP2022-05-02HUMAN PRESCRIPTION DRUG LABEL
Rx onlyPreferred Pharmaceuticals Inc.2021-01-28HUMAN PRESCRIPTION DRUG LABEL
Rx onlyRPK Pharmaceuticals, Inc.2020-12-21HUMAN PRESCRIPTION DRUG LABEL
SILICON DIOXIDE - St. Mary’s Medical Park Pharmacy | Heritage Pharma Labs, IncSt. Mary’s Medical Park Pharmacy | Heritage Pharma Labs, Inc2019-05-10HUMAN PRESCRIPTION DRUG LABEL
Hydroxyzine hydrochloride - Aidarex Pharmaceuticals LLCAidarex Pharmaceuticals LLC2016-11-04HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
23155-500-012020-03-26Rx only
23155-500-052020-03-26Rx only
23155-500-102020-03-26Rx only
23155-500-012020-01-31Rx only
23155-500-052020-01-31Rx only
23155-500-102020-01-31Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-500-01Hydroxyzine hydrochloride100 in 1 BOTTLETABLET10022
23155-500-05Hydroxyzine hydrochloride500 in 1 BOTTLETABLET50022
23155-500-10Hydroxyzine hydrochloride1000 in 1 BOTTLETABLET100022
23155-500-18Hydroxyzine hydrochloride108000 in 1 CONTAINERTABLET10800022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-500HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]22Current NDC, Legacy NDC, 4 package rows20250519_f9ff4b7c-dc81-47af-8371-5c681eb0d876.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-500-01EA - Each23155-500912b07ac-2512-4743-91dc-169d8c48a21b12015-11-12
23155-500-05EA - Each23155-5002c9d5353-9015-4b93-a58d-0c8aa3078c5b12015-11-12
23155-500-10EA - Each23155-50065209e8d-ac27-45c5-8258-67c57a77289612015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]7

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 1 of 140 · 2,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.58d99cf6-2319-410b-b8be-de9c304541b62026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 995218
unii: 76755771U3
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDECoupler LLC5a586fc0-e4e0-5621-e063-6294a90a222b2026-08-31Warnings, Adverse reactionsExact identifier
application number: ANDA204279
rxcui: 995281
unii: 76755771U3
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.8f41912e-12ce-4174-a0fb-cfb4888d8d582026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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