FDA.reportPublic FDA data

Zyrtec Allergy

Product NDC
67751-192
11-digit product format
677510192
Labeler code
67751
Product ID
67751-192_f70c23f1-f2a8-8415-e053-6394a90a64dc
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Navajo Manufacturing Company Incorporated
Application
NDA019835
Marketing category
NDA
Marketing start
2019-11-20
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zyrtec Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678, 1020026

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67751-192-012023-03-16C16284748780-1f386c649-a880-0266-e053-dadaa90a7c1aZyrtec ® Allergy
67751-192-012023-01-30C16284748780-1f386c649-a880-0266-e053-dadaa90a7c1aZyrtec ® Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-192-01Zyrtec Allergy1 in 1 POUCHTABLET, FILM COATED12
67751-192-01Zyrtec Allergy1 in 1 CARTONTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-192ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INCORPORATED]2Current NDC, Legacy NDC, 2 package rows20230317_9c4693cb-f066-0666-e053-2a95a90a96d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN9c4693cb-f066-0666-e053-2a95a90a96d32
1020026ZyrTEC 10 MG Oral TabletPSN9c4693cb-f066-0666-e053-2a95a90a96d32
1020026cetirizine hydrochloride 10 MG Oral Tablet [Zyrtec]SBD9c4693cb-f066-0666-e053-2a95a90a96d32
1014678cetirizine hydrochloride 10 MG Oral TabletSCD9c4693cb-f066-0666-e053-2a95a90a96d32
1014678cetirizine HCl 10 MG Oral TabletSY9c4693cb-f066-0666-e053-2a95a90a96d32
1020026Zyrtec (cetirizine dihydrochloride 10 MG) Oral TabletSY9c4693cb-f066-0666-e053-2a95a90a96d32
1020026Zyrtec 10 MG Oral TabletSY9c4693cb-f066-0666-e053-2a95a90a96d32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-192-01677510192011 POUCH in 1 CARTON (67751-192-01) / 1 TABLET, FILM COATED in 1 POUCH1 pouch2019-11-200000-00-00NoNoCurrent