childrens dye free allergy relief

Product NDC
30142-643
11-digit product format
301420643
Labeler code
30142
Product ID
30142-643_534667f2-34d5-4df1-b1bc-c97f102bb84c
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Kroger Company
Application
ANDA204226
Marketing category
ANDA
Marketing start
2026-04-27
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 dye free 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
30142-643-26childrens dye free allergy relief118 mL in 1 BOTTLESOLUTION1182
30142-643-26childrens dye free allergy relief1 in 1 CARTONSOLUTION12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNc6660c5c-1504-4a92-95e8-cc3a018e813b2
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDc6660c5c-1504-4a92-95e8-cc3a018e813b2
1014673cetirizine HCl 1 MG/ML Oral SyrupSYc6660c5c-1504-4a92-95e8-cc3a018e813b2
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYc6660c5c-1504-4a92-95e8-cc3a018e813b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
30142-643-26301420643261 BOTTLE in 1 CARTON (30142-643-26) / 118 mL in 1 BOTTLE1 bottle2026-04-27NoNoHistorical