careone childrens allergy relief

Product NDC
41520-301
11-digit product format
415200301
Labeler code
41520
Product ID
41520-301_b9b6767c-f3bf-4a95-9acd-13a0424d9c4b
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
American Sales Company
Application
ANDA204226
Marketing category
ANDA
Marketing start
2017-10-09
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
careone childrens allergy relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014673

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
41520-301-26careone childrens allergy relief118 mL in 1 BOTTLESOLUTION1186
41520-301-26careone childrens allergy relief1 in 1 CARTONSOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-301CAREONE CHILDRENS ALLERGY RELIEF (CETIRIZINE HCL) SOLUTION [AMERICAN SALES COMPANY]5Current NDC, Legacy NDC, 2 package rows20250512_a4e43301-3e03-4364-b303-645de1697572.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNa4e43301-3e03-4364-b303-645de16975726
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDa4e43301-3e03-4364-b303-645de16975726
1014673cetirizine HCl 1 MG/ML Oral SyrupSYa4e43301-3e03-4364-b303-645de16975726
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYa4e43301-3e03-4364-b303-645de16975726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-301-26415200301261 BOTTLE in 1 CARTON (41520-301-26) / 118 mL in 1 BOTTLE1 bottle2017-10-090000-00-00NoNoCurrent