FDA.reportPublic FDA data

Childrens All Day Allergy

Product NDC
42507-203
11-digit product format
425070203
Labeler code
42507
Product ID
42507-203_8535c58e-263d-444f-b925-a5ede8b06e85
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
HyVee Inc
Application
ANDA204226
Marketing category
ANDA
Marketing start
2014-02-17
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
Childrens All Day Allergy
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
42507-203-00Childrens All Day Allergy118 mL in 1 BOTTLESOLUTION1184
42507-203-26Childrens All Day Allergy1 in 1 CARTONSOLUTION14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [HYVEE INC]1
CETIRIZINEACTIVE MOIETYYO7261ME24CHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [HYVEE INC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [HYVEE INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [HYVEE INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [HYVEE INC]1
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [HYVEE INC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [HYVEE INC]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [HYVEE INC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN178743fd-5336-4aae-9a0a-5ff17aeb37624
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD178743fd-5336-4aae-9a0a-5ff17aeb37624
1014673cetirizine HCl 1 MG/ML Oral SyrupSY178743fd-5336-4aae-9a0a-5ff17aeb37624
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY178743fd-5336-4aae-9a0a-5ff17aeb37624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-203-0042507020300118 mL in 1 BOTTLE118 mlHistorical
42507-203-26425070203261 BOTTLE in 1 CARTON (42507-203-26) / 118 mL in 1 BOTTLE (42507-203-00) 1 bottle2014-02-17NoNoHistorical