FDA.reportPublic FDA data

allergy relief

Product NDC
59779-837
11-digit product format
597790837
Labeler code
59779
Product ID
59779-837_e68db09c-7fe6-42de-9ae3-96dbc5261ec7
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA204226
Marketing category
ANDA
Marketing start
2015-09-11
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
allergy relief
Brand name suffix
childrens
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-837-26allergy reliefchildrens120 mL in 1 BOTTLESOLUTION1205
59779-837-26allergy reliefchildrens1 in 1 CARTONSOLUTION15
59779-837-34allergy reliefchildrens240 mL in 1 BOTTLESOLUTION2405
59779-837-34allergy reliefchildrens1 in 1 CARTONSOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-837-26ML - Milliliter59779-83725443d5b-607c-4c3d-86ea-3b148e335b5912017-04-05
59779-837-34ML - Milliliter59779-83798483816-683c-41cf-832e-becde310b55b12022-03-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOAALLERGY RELIEF CHILDRENS (CETIRIZINE HCL) SOLUTION [CVS PHARMACY]1
CETIRIZINEACTIVE MOIETYYO7261ME24ALLERGY RELIEF CHILDRENS (CETIRIZINE HCL) SOLUTION [CVS PHARMACY]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLALLERGY RELIEF CHILDRENS (CETIRIZINE HCL) SOLUTION [CVS PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ALLERGY RELIEF CHILDRENS (CETIRIZINE HCL) SOLUTION [CVS PHARMACY]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALLERGY RELIEF CHILDRENS (CETIRIZINE HCL) SOLUTION [CVS PHARMACY]1
SORBITOLINACTIVE INGREDIENT506T60A25RALLERGY RELIEF CHILDRENS (CETIRIZINE HCL) SOLUTION [CVS PHARMACY]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ALLERGY RELIEF CHILDRENS (CETIRIZINE HCL) SOLUTION [CVS PHARMACY]1
WATERINACTIVE INGREDIENT059QF0KO0RALLERGY RELIEF CHILDRENS (CETIRIZINE HCL) SOLUTION [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-837ALLERGY RELIEF CHILDRENS (CETIRIZINE HCL) SOLUTION [CVS PHARMACY]5Current NDC, Legacy NDC, 4 package rows20250316_1a20acb5-207f-4499-a4c3-873345455538.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN1a20acb5-207f-4499-a4c3-8733454555385
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD1a20acb5-207f-4499-a4c3-8733454555385
1014673cetirizine HCl 1 MG/ML Oral SyrupSY1a20acb5-207f-4499-a4c3-8733454555385
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY1a20acb5-207f-4499-a4c3-8733454555385

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-837-26597790837261 BOTTLE in 1 CARTON (59779-837-26) / 120 mL in 1 BOTTLE1 bottle2015-09-110000-00-00NoNoCurrent
59779-837-34597790837341 BOTTLE in 1 CARTON (59779-837-34) / 240 mL in 1 BOTTLE1 bottle2015-09-110000-00-00NoNoCurrent