FDA.reportPublic FDA data

Allergy Relief

Product NDC
84324-001
11-digit product format
843240001
Labeler code
84324
Product ID
84324-001_259d4274-1a91-4c14-8e80-874b2c44ab62
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
NUVICARE LLC
Application
ANDA077829
Marketing category
ANDA
Marketing start
2024-07-17
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
84324-001-01Allergy Relief100 in 1 BOTTLETABLET1002
84324-001-02Allergy Relief14 in 1 BLISTER PACKTABLET141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84324-001ALLERGY RELIEF (CETIRIZINE HCL) TABLET [NUVICARE LLC]1Current NDC, 1 package rows20240717_c728edf3-e6b5-4860-b966-39cf3ee4ff77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNc728edf3-e6b5-4860-b966-39cf3ee4ff772
1014678cetirizine hydrochloride 10 MG Oral TabletSCDc728edf3-e6b5-4860-b966-39cf3ee4ff772
1014678cetirizine HCl 10 MG Oral TabletSYc728edf3-e6b5-4860-b966-39cf3ee4ff772
1014678cetirizine HCl 10 MG Oral TabletPSN09dfdce2-7184-4247-983c-a5667e4a9da11
1014678cetirizine hydrochloride 10 MG Oral TabletSCD09dfdce2-7184-4247-983c-a5667e4a9da11
1014678cetirizine HCl 10 MG Oral TabletSY09dfdce2-7184-4247-983c-a5667e4a9da11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84324-001-0184324000101100 TABLET in 1 BOTTLE (84324-001-01) 100 tablet2024-07-17NoNoCurrent
84324-001-028432400010214 TABLET in 1 BLISTER PACK (84324-001-02) 14 tablet2025-06-09NoNoCurrent