ALLERGY RELIEF

Product NDC
53943-194
11-digit product format
539430194
Labeler code
53943
Product ID
53943-194_af0d3f87-af0b-23a5-e053-2995a90a338a
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
DISCOUNT DRUG MART
Application
ANDA209274
Marketing category
ANDA
Marketing start
2019-01-17
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
53943-194-13ALLERGY RELIEF2 in 1 CARTONTABLET, COATED22
53943-194-13ALLERGY RELIEF90 in 1 BOTTLE, PLASTICTABLET, COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-194ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, COATED [DISCOUNT DRUG MART]2Current NDC, Legacy NDC, 2 package rows20200912_844e0e60-f293-4588-9f34-c866bdad6f53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN844e0e60-f293-4588-9f34-c866bdad6f532
1014678cetirizine hydrochloride 10 MG Oral TabletSCD844e0e60-f293-4588-9f34-c866bdad6f532
1014678cetirizine HCl 10 MG Oral TabletSY844e0e60-f293-4588-9f34-c866bdad6f532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53943-194-13539430194132 BOTTLE, PLASTIC in 1 CARTON (53943-194-13) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC2019-01-170000-00-00NoNoCurrent