FDA.reportPublic FDA data

NDC 67046-680-03 - Cetirizine

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
67046-680
Requested NDC
67046-680-03
Package NDCs from labels
67046-680-30, 67046-680-03
Manufacturer
Contract Pharmacy Services-PA | Coupler Enterprises Inc.
Effective date
2018-04-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cetirizine - Contract Pharmacy Services-PA | Coupler Enterprises Inc.Contract Pharmacy Services-PA | Coupler Enterprises Inc.2018-04-22HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-680-302022-01-28C16284748780-1d6a99b39-b742-a426-e053-dadaa90af4c2Cetirizine 10mg 680 "These highlights do not include all the information needed to use" "see full prescribing information for" "Initial U.S. Approval"

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-680-30Cetirizine30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-680CETIRIZINE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20180422_6a707324-b32b-9741-e053-2a91aa0a2af2.zip

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 26 · 501 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
application number: ANDA078336
rxcui: 1014678
unii: 64O047KTOA
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.e4852fc2-b763-40e2-b8bb-a3f6da5c72fe2026-09-03Warnings, Adverse reactionsExact identifier
unii: X0Z7454B90
Prazosin hydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.b55790fa-2413-4243-83ec-0391b2effe112026-09-02Warnings, Adverse reactionsExact identifier
unii: X0Z7454B90
childrens cetirizine hydrochlorideCETIRIZINE HCLATLANTIC BIOLOGICALS CORP.cb47e536-8eed-4a32-b9c2-e8535fb938862026-09-01WarningsExact identifier
unii: 64O047KTOA
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEMajor Pharmaceuticals4f55f4db-dab3-4e50-9f71-5595fd3ccc122026-09-01Warnings, Adverse reactionsExact identifier
application number: ANDA210971
rxcui: 312593
unii: X0Z7454B90
Allergy ReliefCETIRIZINE HCLCVS PHARMACY, INCfb850a4c-7ac1-4993-b6ea-5c8d42e177032026-08-26WarningsExact identifier
unii: 64O047KTOA
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.fd860756-9b2e-4bfd-9063-bc4d26366fe62026-08-26Warnings, Adverse reactionsExact identifier
application number: ANDA210971
rxcui: 312593
unii: X0Z7454B90
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

Reported adverse events (FAERS/openFDA)#

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