Childrens

Product NDC
49035-106
11-digit product format
490350106
Labeler code
49035
Product ID
49035-106_26f1efff-e30b-4c6b-b1d1-51be507fbef1
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA201546
Marketing category
ANDA
Marketing start
2011-05-20
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
Brand name suffix
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
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-106-08Childrens Allergy Relief120 mL in 1 BOTTLESOLUTION1203
49035-106-08Childrens Allergy Relief1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-106-08ML - Milliliter49035-106771f7653-355a-49d3-8d73-f5f44da631a212015-06-09

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-106CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]3Current NDC, Legacy NDC, 2 package rows20180216_0d026538-5708-4030-b65d-18790e72059a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN0d026538-5708-4030-b65d-18790e72059a3
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD0d026538-5708-4030-b65d-18790e72059a3
1014673cetirizine HCl 1 MG/ML Oral SyrupSY0d026538-5708-4030-b65d-18790e72059a3
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY0d026538-5708-4030-b65d-18790e72059a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-106-08490350106081 BOTTLE in 1 CARTON (49035-106-08) / 120 mL in 1 BOTTLE1 bottle2011-05-200000-00-00NoNoCurrent