CareOne Allergy Relief

Product NDC
41520-715
11-digit product format
415200715
Labeler code
41520
Product ID
41520-715_ee2f07ef-66a7-476e-b4e5-ed887992bf9e
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
American Sales Company
Application
ANDA207235
Marketing category
ANDA
Marketing start
2021-08-03
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
CareOne Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014675

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
41520-715-63CareOne Allergy Relief25 in 1 BOTTLECAPSULE, LIQUID FILLED252
41520-715-63CareOne Allergy Relief1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-715CAREONE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AMERICAN SALES COMPANY]2Current NDC, Legacy NDC, 2 package rows20210818_833e8904-d37d-4478-af7c-8287f2d079a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN833e8904-d37d-4478-af7c-8287f2d079a72
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD833e8904-d37d-4478-af7c-8287f2d079a72
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY833e8904-d37d-4478-af7c-8287f2d079a72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-715-63415200715631 BOTTLE in 1 CARTON (41520-715-63) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2021-08-030000-00-00NoNoCurrent