FDA.reportPublic FDA data

Allergy Relief

Product NDC
61504-194
11-digit product format
615040194
Labeler code
61504
Product ID
61504-194_092d4666-dc93-1c0f-e063-6294a90a7aaf
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Amerifoods Trading Company
Application
ANDA209274
Marketing category
ANDA
Marketing start
2023-10-30
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
61504-194-14Allergy Relief30 in 1 BOTTLE, PLASTICTABLET, COATED302
61504-194-14Allergy Relief1 in 1 CARTONTABLET, COATED12
61504-194-16Allergy Relief90 in 1 BOTTLE, PLASTICTABLET, COATED902
61504-194-16Allergy Relief1 in 1 CARTONTABLET, COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61504-194ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, COATED [AMERIFOODS TRADING COMPANY]2Current NDC, 4 package rows20231103_f6ce3cdf-2e6d-61e8-e053-6294a90af7d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNf6ce3cdf-2e6d-61e8-e053-6294a90af7d32
1014678cetirizine hydrochloride 10 MG Oral TabletSCDf6ce3cdf-2e6d-61e8-e053-6294a90af7d32
1014678cetirizine HCl 10 MG Oral TabletSYf6ce3cdf-2e6d-61e8-e053-6294a90af7d32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61504-194-14615040194141 BOTTLE, PLASTIC in 1 CARTON (61504-194-14) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC2023-10-30NoNoCurrent
61504-194-16615040194161 BOTTLE, PLASTIC in 1 CARTON (61504-194-16) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC2023-10-30NoNoCurrent