childrens allergy relief

Product NDC
21130-465
11-digit product format
211300465
Labeler code
21130
Product ID
21130-465_81d6b4b4-2c46-4727-82fe-f7cedce89cc5
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Safeway
Application
ANDA204226
Marketing category
ANDA
Marketing start
2024-07-31
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
21130-465-34childrens allergy relief240 mL in 1 BOTTLESOLUTION2402
21130-465-34childrens allergy relief1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-465CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [SAFEWAY]2Current NDC, 2 package rows20240806_5d3e4c52-b697-4b91-af28-124f74d937e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN5d3e4c52-b697-4b91-af28-124f74d937e52
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD5d3e4c52-b697-4b91-af28-124f74d937e52
1014673cetirizine HCl 1 MG/ML Oral SyrupSY5d3e4c52-b697-4b91-af28-124f74d937e52
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY5d3e4c52-b697-4b91-af28-124f74d937e52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-465-34211300465341 BOTTLE in 1 CARTON (21130-465-34) / 240 mL in 1 BOTTLE1 bottle2024-07-31NoNoCurrent