FDA.reportPublic FDA data

NDC 58602-812-83 - Cetirizine Hydrochloride (Allergy)

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
58602-812
Requested NDC
58602-812-83
Package NDCs from labels
58602-812-09, 58602-812-17, 58602-812-99, 58602-812-23, 58602-812-39, 58602-812-41, 58602-812-83, 58602-812-04
Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED | Aurobindo Pharma Limited
Effective date
2026-08-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CETIRIZINE - Aurohealth LLC | APL HEALTHCARE LIMITED | Aurobindo Pharma LimitedAurohealth LLC | APL HEALTHCARE LIMITED | Aurobindo Pharma Limited2026-08-03Human OTC Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-812-04Cetirizine Hydrochloride (Allergy)10 in 1 CARTONTABLET1011
58602-812-09Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET111
58602-812-09Cetirizine Hydrochloride (Allergy)30 in 1 BOTTLETABLET3011
58602-812-17Cetirizine Hydrochloride (Allergy)45 in 1 BOTTLETABLET4511
58602-812-17Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET111
58602-812-23Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET111
58602-812-23Cetirizine Hydrochloride (Allergy)120 in 1 BOTTLETABLET12011
58602-812-39Cetirizine Hydrochloride (Allergy)365 in 1 BOTTLETABLET36511
58602-812-39Cetirizine Hydrochloride (Allergy)1 in 1 CARTONTABLET111
58602-812-41Cetirizine Hydrochloride (Allergy)1000 in 1 BOTTLETABLET100011
58602-812-83Cetirizine Hydrochloride (Allergy)10 in 1 BLISTER PACKTABLET1011
58602-812-99Cetirizine Hydrochloride (Allergy)75 in 1 PACKAGE, COMBINATIONTABLET7511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-812CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]11Current NDC, Legacy NDC, 12 package rows20240915_3cf969e6-6bc9-4dae-ab6a-b24c0fc46b25.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]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 1 of 159 · 3,163 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
Allergy ReliefCETIRIZINE HYDROCHLORIDELIDL US LLCe5fd935d-5b60-7270-e053-2995a90a71412026-09-09WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
all day allergyCETIRIZINE HYDROCHLORIDERite Aid Corporationbcbb9f5a-10b6-4a5e-a237-d29693d781032026-09-04WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
childrens cetirizine hydrochlorideCETIRIZINE HCLATLANTIC BIOLOGICALS CORP.cb47e536-8eed-4a32-b9c2-e8535fb938862026-09-01WarningsExact identifier
unii: 64O047KTOA
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Allergy ReliefCETIRIZINE HCLCVS PHARMACY, INCfb850a4c-7ac1-4993-b6ea-5c8d42e177032026-08-26WarningsExact identifier
unii: 64O047KTOA
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
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEBAJAJ MEDICAL, LLC36b24a3c-6284-5a6d-e063-6394a90a77432026-08-26WarningsExact identifier
unii: 64O047KTOA
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEBAJAJ MEDICAL, LLC36b6d0e4-8da5-9df5-e063-6294a90af3262026-08-26WarningsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC26f2c3c1-a2f2-474a-950a-8cfe07f289fa2026-08-25WarningsExact identifier
unii: 64O047KTOA
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAurohealth LLC17e93c22-1ff7-4af9-bd5a-448836aec65f2026-08-25WarningsExact identifier
unii: 64O047KTOA
Childrens Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAurohealth LLCcd895177-3c25-4a1b-81a0-b85f4877787a2026-08-25WarningsExact identifier
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

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