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 2 of 157 · 3,138 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEStrides Pharma, Inc.29c433eb-6cf4-4bcf-8b2a-0398fb4cdcba2026-08-24WarningsExact identifier
unii: 64O047KTOA
Cetirizine HClCETIRIZINE HCLCVS Pharmacy52192baa-3ce4-b2c3-e063-6294a90a28fc2026-08-24WarningsExact identifier
unii: 64O047KTOA
Zyrtec Allergy Cetirizine HClCETIRIZINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc59cf7672-fdde-ddbd-e063-6394a90a223b2026-08-24WarningsExact identifier
unii: 64O047KTOA
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
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEBetter Living Brands, LLCf7e16d96-4f23-cbca-e053-6394a90aef4e2026-08-24WarningsExact identifier
application number: ANDA090760
rxcui: 1014678
unii: 64O047KTOA
GOOD REMEDIES All Day Allergy ReliefCETIRIZINE HYDROCHLORIDEStrive Pharmaceuticals Inc.44410d76-5940-4611-be45-579e2db8a65d2026-08-24WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
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
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4913192a-7364-3f19-e054-00144ff8d46c2026-08-20WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
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
Zyrtec Allergy Cetirizine HClCETIRIZINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc59cef432-41ac-768c-e063-6294a90a38fa2026-08-19WarningsExact identifier
unii: 64O047KTOA
allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company678dcc09-55da-4d9d-a39a-c450c61c387b2026-08-18WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
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

Reported adverse events (FAERS/openFDA)#

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