CAREALL Allergy Relief

Product NDC
51824-104
11-digit product format
518240104
Labeler code
51824
Product ID
51824-104_44eb5cdd-4af8-b98a-e063-6294a90ab5c6
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
New World Imports
Application
ANDA209274
Marketing category
ANDA
Marketing start
2023-12-07
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
CAREALL 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
51824-104-30CAREALL Allergy Relief30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-104-30EA - Each51824-1042186843a-df6b-4c74-8d81-83eded38735a12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-104CAREALL ALLERGY RELIEF (CETIRIZINE HCL) TABLET [NEW WORLD IMPORTS]1Current NDC, 1 package rows20231208_d3411eec-05b1-49b3-86e8-bc47ac0ef6b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNd3411eec-05b1-49b3-86e8-bc47ac0ef6b72
1014678cetirizine hydrochloride 10 MG Oral TabletSCDd3411eec-05b1-49b3-86e8-bc47ac0ef6b72
1014678cetirizine HCl 10 MG Oral TabletSYd3411eec-05b1-49b3-86e8-bc47ac0ef6b72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51824-104-305182401043030 TABLET in 1 BOTTLE (51824-104-30) 30 tablet2023-12-07NoNoHistorical