FDA.reportPublic FDA data

childrens all day allergy

Product NDC
30142-189
11-digit product format
301420189
Labeler code
30142
Product ID
30142-189_53f8b3ca-654c-4a53-86fe-70ed0f469550
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Kroger Company
Application
ANDA204226
Marketing category
ANDA
Marketing start
2016-03-10
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
childrens all day allergy
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
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-189-26childrens all day allergy1 in 1 CARTONSOLUTION14
30142-189-26childrens all day allergy120 mL in 1 BOTTLESOLUTION1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-189CHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [KROGER COMPANY]4Current NDC, Legacy NDC, 2 package rows20200822_2d95549e-2dce-4f88-adfb-aaae0cc130b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN2d95549e-2dce-4f88-adfb-aaae0cc130b64
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD2d95549e-2dce-4f88-adfb-aaae0cc130b64
1014673cetirizine HCl 1 MG/ML Oral SyrupSY2d95549e-2dce-4f88-adfb-aaae0cc130b64
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY2d95549e-2dce-4f88-adfb-aaae0cc130b64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-189-26301420189261 BOTTLE in 1 CARTON (30142-189-26) / 120 mL in 1 BOTTLE1 bottle2016-03-100000-00-00NoNoCurrent