childrens allergy relief

Product NDC
0363-3393
11-digit product format
003633393
Labeler code
0363
Product ID
0363-3393_58393fad-a47a-4948-90c5-7fc175d85a61
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Walgreen Company
Application
ANDA204226
Marketing category
ANDA
Marketing start
2022-08-09
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 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
0363-3393-26childrens allergy relief120 mL in 1 BOTTLESOLUTION1203
0363-3393-26childrens allergy relief1 in 1 CARTONSOLUTION13
0363-3393-34childrens allergy relief240 mL in 1 BOTTLESOLUTION2403
0363-3393-34childrens allergy relief1 in 1 CARTONSOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-3393CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WALGREEN COMPANY]3Current NDC, Legacy NDC, 4 package rows20250501_5cdd59a0-4d23-4f51-9aca-d66a639f8472.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN5cdd59a0-4d23-4f51-9aca-d66a639f84723
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD5cdd59a0-4d23-4f51-9aca-d66a639f84723
1014673cetirizine HCl 1 MG/ML Oral SyrupSY5cdd59a0-4d23-4f51-9aca-d66a639f84723
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY5cdd59a0-4d23-4f51-9aca-d66a639f84723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-3393-26003633393261 BOTTLE in 1 CARTON (0363-3393-26) / 120 mL in 1 BOTTLE1 bottle2022-08-090000-00-00NoNoCurrent
0363-3393-34003633393341 BOTTLE in 1 CARTON (0363-3393-34) / 240 mL in 1 BOTTLE1 bottle2022-08-090000-00-00NoNoCurrent