FDA.reportPublic FDA data

CareOne Allergy Relief

Product NDC
41520-781
11-digit product format
415200781
Labeler code
41520
Product ID
41520-781_11e72e08-b407-4a84-a79e-1f14b987b1ec
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Sales Company
Application
ANDA078336
Marketing category
ANDA
Marketing start
2016-09-29
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
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
41520-781-06CareOne Allergy Relief70 in 1 BOTTLETABLET, FILM COATED705
41520-781-06CareOne Allergy Relief1 in 1 CARTONTABLET, FILM COATED15
41520-781-39CareOne Allergy Relief1 in 1 CARTONTABLET, FILM COATED15
41520-781-39CareOne Allergy Relief30 in 1 BOTTLETABLET, FILM COATED305
41520-781-58CareOne Allergy Relief1 in 1 CARTONTABLET, FILM COATED15
41520-781-58CareOne Allergy Relief40 in 1 BOTTLETABLET, FILM COATED405
41520-781-66CareOne Allergy Relief1 in 1 BLISTER PACKTABLET, FILM COATED15
41520-781-66CareOne Allergy Relief14 in 1 CARTONTABLET, FILM COATED145
41520-781-75CareOne Allergy Relief1 in 1 CARTONTABLET, FILM COATED15
41520-781-75CareOne Allergy Relief90 in 1 BOTTLETABLET, FILM COATED905
41520-781-76CareOne Allergy Relief1 in 1 CARTONTABLET, FILM COATED15
41520-781-76CareOne Allergy Relief120 in 1 BOTTLETABLET, FILM COATED1205
41520-781-95CareOne Allergy Relief45 in 1 BOTTLETABLET, FILM COATED455
41520-781-95CareOne Allergy Relief1 in 1 CARTONTABLET, FILM COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-781CAREONE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN SALES COMPANY]4Current NDC, Legacy NDC, 14 package rows20191106_533abfc1-226e-4a68-bfcc-ec046a4d5751.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN533abfc1-226e-4a68-bfcc-ec046a4d57515
1014678cetirizine hydrochloride 10 MG Oral TabletSCD533abfc1-226e-4a68-bfcc-ec046a4d57515
1014678cetirizine HCl 10 MG Oral TabletSY533abfc1-226e-4a68-bfcc-ec046a4d57515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-781-06415200781061 BOTTLE in 1 CARTON (41520-781-06) / 70 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-09-290000-00-00NoNoCurrent
41520-781-39415200781391 BOTTLE in 1 CARTON (41520-781-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-09-290000-00-00NoNoCurrent
41520-781-58415200781581 BOTTLE in 1 CARTON (41520-781-58) > 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-10-290000-00-00NoNoCurrent
41520-781-664152007816614 BLISTER PACK in 1 CARTON (41520-781-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK14 blister pack2016-09-290000-00-00NoNoCurrent
41520-781-75415200781751 BOTTLE in 1 CARTON (41520-781-75) > 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-09-290000-00-00NoNoCurrent
41520-781-76415200781761 BOTTLE in 1 CARTON (41520-781-76) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-04-120000-00-00NoNoCurrent
41520-781-95415200781951 BOTTLE in 1 CARTON (41520-781-95) > 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-09-290000-00-00NoNoCurrent