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 2 of 140 · 2,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Agri-ChordARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOSEnergetix Corporation9eb50e9a-3528-4809-bd76-47d99ef03f0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Drainage-ToneCALCAREA IODATA, CAPSICUM ANNUUM, COENZYME A, ECHINACEA ANGUSTIFOLIA, EQUISETUM ARVENSE, HYDRASTIS CANADENSIS, NADIDUM, NITRICUM ACIDUM, OLEUM MORRHUAE, PETROSELINUM SATIVUM, PHYTOLACCA DECANDRA, SCROPHULARIA NODOSA, SILICEA, SINAPIS ALBA, THUJA OCCIDENTALIS.Energetix Corporation296b455e-27c5-4f6e-929d-c4ee75b7fb0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
HypothalmapathGELSEMIUM, GINKGO, GLYCYRRHIZA, HYDROCOTYLE, HYPOTHALAMUS, PETROSELINUM, PITUITARUM POSTERIUM, PYRIDOXINUM HYDROCHLORICUM, SENNA, SILICEAEnergetix Corporation3c4e2867-4d75-416b-9f3d-e6e500e46f6f2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph-Tone IIAESCULUS HIPP, AZADIRACHTA, BARYTA CARB, BERBER VULG, BOLDO, BUFO, CALC CARB, CALC PHOS, COENZYME A, COLLINSONIA, ECHINACEA, FERRUM PHOS, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KREOSOTUM, NADIDUM, NAT MUR, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PIX LIQUIDA, PULSATILLA, SILICEA, STILLINGIA, THUJA OCC.Energetix Corporationc46aa8d3-4aa5-4e07-be3d-d71abc5e24072026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Lymph-Tone IIIADENOSINUM CYCLOPHOSPHORICUM, ARNICA, BOLDO, CALC IOD, CALENDULA, CARTILAGO SUIS, CEANOTHUS, COENZYME A, ECHINACEA, HAMAMELIS, HEPAR SULPH CALC, HYPOTHALAMUS, NADIDUM, NAJA, NAT SULPHURICUM, PHASEOLUS, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PYROGENIUM, SILICEA, SULPHUR, THUJA OCC, THYROIDINUM, VISCUMEnergetix Corporation4c9ae54c-ce7d-4276-add7-2922a8f0e3102026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
MetabopathADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,Energetix Corporation58bfe670-d308-45a2-8046-7897b62214522026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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