Allergy Relief

Product NDC
53943-219
11-digit product format
539430219
Labeler code
53943
Product ID
53943-219_f0ff6c1c-a2cf-11d1-e053-2a95a90adb24
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
DISCOUNT DRUG MART, INC.
Application
NDA022429
Marketing category
NDA
Marketing start
2019-08-02
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
Rxcui1014675

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
53943-219-40Allergy Relief1 in 1 CARTONCAPSULE12
53943-219-40Allergy Relief40 in 1 BOTTLECAPSULE402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-219ALLERGY RELIEF (CETIRIZINE HCL) CAPSULE [DISCOUNT DRUG MART, INC.]2Current NDC, Legacy NDC, 2 package rows20221230_89c77f0d-a325-4f8f-9142-98c0d41de8b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN89c77f0d-a325-4f8f-9142-98c0d41de8b12
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD89c77f0d-a325-4f8f-9142-98c0d41de8b12
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY89c77f0d-a325-4f8f-9142-98c0d41de8b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-219-40539430219401 BOTTLE in 1 CARTON (53943-219-40) / 40 CAPSULE in 1 BOTTLE1 bottle2019-08-020000-00-00NoNoCurrent