FDA.reportPublic FDA data

Allergy Relief

Product NDC
81522-194
11-digit product format
815220194
Labeler code
81522
Product ID
81522-194_2fc20c71-6615-68d4-e063-6294a90a736e
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
FSA STORE INC.
Application
ANDA209274
Marketing category
ANDA
Marketing start
2023-01-11
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
81522-194-04Allergy Relief1 in 1 CARTONTABLET, COATED13
81522-194-04Allergy Relief45 in 1 BOTTLE, PLASTICTABLET, COATED453
81522-194-16Allergy Relief1 in 1 CARTONTABLET, COATED13
81522-194-16Allergy Relief90 in 1 BOTTLE, PLASTICTABLET, COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81522-194ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, COATED [FSA STORE INC.]3Current NDC, Legacy NDC, 4 package rows20250309_ec6b4e86-ac27-e1f2-e053-2a95a90ab3e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNec6b4e86-ac27-e1f2-e053-2a95a90ab3e13
1014678cetirizine hydrochloride 10 MG Oral TabletSCDec6b4e86-ac27-e1f2-e053-2a95a90ab3e13
1014678cetirizine HCl 10 MG Oral TabletSYec6b4e86-ac27-e1f2-e053-2a95a90ab3e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81522-194-04815220194041 BOTTLE, PLASTIC in 1 CARTON (81522-194-04) / 45 TABLET, COATED in 1 BOTTLE, PLASTIC2023-01-110000-00-00NoNoCurrent
81522-194-16815220194161 BOTTLE, PLASTIC in 1 CARTON (81522-194-16) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC2025-03-03NoNoHistorical