Allergy Relief

Product NDC
67091-494
11-digit product format
670910494
Labeler code
67091
Product ID
67091-494_f91594ff-8c0c-0385-e053-6394a90a04e7
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
WINCO FOODS, LLC
Application
ANDA209274
Marketing category
ANDA
Marketing start
2023-04-11
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
Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-494-14Allergy Relief1 in 1 CARTONTABLET, COATED12
67091-494-14Allergy Relief30 in 1 BOTTLE, PLASTICTABLET, COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-494ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, COATED [WINCO FOODS, LLC]2Current NDC, 2 package rows20230412_f45f5920-d82f-6549-e053-2995a90ad58a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNf45f5920-d82f-6549-e053-2995a90ad58a2
1014678cetirizine hydrochloride 10 MG Oral TabletSCDf45f5920-d82f-6549-e053-2995a90ad58a2
1014678cetirizine HCl 10 MG Oral TabletSYf45f5920-d82f-6549-e053-2995a90ad58a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67091-494-14670910494141 BOTTLE, PLASTIC in 1 CARTON (67091-494-14) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC2023-04-11NoNoCurrent