Welby Childrens Allergy Relief

Product NDC
64024-475
11-digit product format
640240475
Labeler code
64024
Product ID
64024-475_a8fd50c6-1a27-4ed2-8a63-f9b9918ffb4a
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Aldi Inc
Application
ANDA204226
Marketing category
ANDA
Marketing start
2022-03-02
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
Welby 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
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64024-475-26Welby Childrens Allergy Relief1 in 1 CARTONSOLUTION11
64024-475-26Welby Childrens Allergy Relief120 mL in 1 BOTTLESOLUTION1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64024-475WELBY CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [ALDI INC]1Current NDC, Legacy NDC, 2 package rows20221014_a8fd50c6-1a27-4ed2-8a63-f9b9918ffb4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNa8fd50c6-1a27-4ed2-8a63-f9b9918ffb4a1
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDa8fd50c6-1a27-4ed2-8a63-f9b9918ffb4a1
1014673cetirizine HCl 1 MG/ML Oral SyrupSYa8fd50c6-1a27-4ed2-8a63-f9b9918ffb4a1
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYa8fd50c6-1a27-4ed2-8a63-f9b9918ffb4a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64024-475-26640240475261 BOTTLE in 1 CARTON (64024-475-26) / 120 mL in 1 BOTTLE1 bottle2022-03-020000-00-00NoNoCurrent