FDA.reportPublic FDA data

NDC 16853-1305-1 - ALLEROFF

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
16853-1305
Requested NDC
16853-1305-1
Package NDCs from labels
16853-1305-1, 16853-1305-2, 16853-1305-3
Manufacturer
Corporacion Infarmasa
Effective date
2010-02-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ALLEROFF - Corporacion InfarmasaCorporacion Infarmasa2010-02-15HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16853-1305-22019-10-21C16284748780-1956f9ecf-cea6-621f-e053-dbdaa90a74adDrug Facts
16853-1305-32019-10-21C16284748780-1956f9ecf-cea6-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16853-1305-1ALLEROFF000000000010 in 1 BLISTER PACKTABLET0000000000102
16853-1305-2ALLEROFF00000000000001 in 1 BOXTABLET000000000000012
16853-1305-3ALLEROFF0000000002 in 1 BLISTER PACKTABLET00000000022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16853-1305ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]2Legacy NDC, 3 package rows20100603_2e431020-bf57-46a7-bbfd-487b87d00ffb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOAALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]2
CetirizineACTIVE MOIETYYO7261ME24ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]2

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 22 · 427 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
childrens cetirizine hydrochlorideCETIRIZINE HCLATLANTIC BIOLOGICALS CORP.cb47e536-8eed-4a32-b9c2-e8535fb938862026-09-01WarningsExact identifier
unii: 64O047KTOA
Allergy ReliefCETIRIZINE HCLCVS PHARMACY, INCfb850a4c-7ac1-4993-b6ea-5c8d42e177032026-08-26WarningsExact identifier
unii: 64O047KTOA
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
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
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
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEBetter Living Brands, LLCf7e16d96-4f23-cbca-e053-6394a90aef4e2026-08-24WarningsExact identifier
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
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4913192a-7364-3f19-e054-00144ff8d46c2026-08-20WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
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
AMAZON BASICS ALL DAY ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEAmazon.com Services LLC52163488-0b56-529d-e063-6294a90afc622026-08-17WarningsExact identifier
unii: 64O047KTOA
QUZYTTIRCETIRIZINE HYDROCHLORIDEESTEVE PHARMACEUTICALS, S.A.573770f6-b76e-f6ba-e063-6294a90aa54d2026-08-13Warnings, Adverse reactionsExact identifier
unii: 64O047KTOA
allergy relief childrensCETIRIZINE HCLCVS Pharmacy1a20acb5-207f-4499-a4c3-8733454555382026-08-13WarningsExact identifier
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

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