Equaline childrens all day allergy

Product NDC
41163-475
11-digit product format
411630475
Labeler code
41163
Product ID
41163-475_c99843ad-3ee8-4fc0-843d-75ed4d53eebe
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA204226
Marketing category
ANDA
Marketing start
2015-11-17
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
Equaline childrens all day allergy
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
41163-475-26Equaline childrens all day allergy1 in 1 CARTONSOLUTION15
41163-475-26Equaline childrens all day allergy118 mL in 1 BOTTLESOLUTION1185
41163-475-34Equaline childrens all day allergy1 in 1 CARTONSOLUTION15
41163-475-34Equaline childrens all day allergy240 mL in 1 BOTTLESOLUTION2405

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-475-26ML - Milliliter41163-475c5ab9b0e-9d8a-4b35-a6d8-d9375a809a1312017-03-06
41163-475-34ML - Milliliter41163-475c52af8fe-ef26-4a0e-b22e-b9f2bd9e0b3512017-08-11

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-475EQUALINE CHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [UNITED NATURAL FOODS, INC. DBA UNFI]5Current NDC, Legacy NDC, 4 package rows20250501_edd4240d-f719-4336-88fe-0960cd8006e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNedd4240d-f719-4336-88fe-0960cd8006e05
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDedd4240d-f719-4336-88fe-0960cd8006e05
1014673cetirizine HCl 1 MG/ML Oral SyrupSYedd4240d-f719-4336-88fe-0960cd8006e05
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYedd4240d-f719-4336-88fe-0960cd8006e05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-475-26411630475261 BOTTLE in 1 CARTON (41163-475-26) / 118 mL in 1 BOTTLE1 bottle2015-11-170000-00-00NoNoCurrent
41163-475-34411630475341 BOTTLE in 1 CARTON (41163-475-34) > 240 mL in 1 BOTTLE1 bottle2016-01-070000-00-00NoNoCurrent