careone childrens allergy relief

Product NDC
41520-902
11-digit product format
415200902
Labeler code
41520
Product ID
41520-902_10d54909-6779-4ef2-b41e-50c4a34d3494
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
American Sales Company
Application
ANDA204226
Marketing category
ANDA
Marketing start
2016-06-23
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
careone childrens allergy relief
Listing expiration
2026-12-31

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-902-26careone childrens allergy relief1 in 1 CARTONSOLUTION14
41520-902-26careone childrens allergy relief118 mL in 1 BOTTLESOLUTION1184
41520-902-34careone childrens allergy relief1 in 1 CARTONSOLUTION14
41520-902-34careone childrens allergy relief240 mL in 1 BOTTLESOLUTION2404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-902CAREONE CHILDRENS ALLERGY RELIEF (CETIRIZINE HCL) SOLUTION [AMERICAN SALES COMPANY]3Current NDC, Legacy NDC, 4 package rows20181218_0582736b-e129-4048-967c-6270c776f9db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN0582736b-e129-4048-967c-6270c776f9db4
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD0582736b-e129-4048-967c-6270c776f9db4
1014673cetirizine HCl 1 MG/ML Oral SyrupSY0582736b-e129-4048-967c-6270c776f9db4
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY0582736b-e129-4048-967c-6270c776f9db4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-902-26415200902261 BOTTLE in 1 CARTON (41520-902-26) / 118 mL in 1 BOTTLE1 bottle2016-06-230000-00-00NoNoCurrent
41520-902-34415200902341 BOTTLE in 1 CARTON (41520-902-34) > 240 mL in 1 BOTTLE1 bottle2016-06-230000-00-00NoNoCurrent