Western Family

Product NDC
55312-106
11-digit product format
553120106
Labeler code
55312
Product ID
55312-106_7eff942d-f18e-498c-abcf-0bcb46834644
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Western Family Foods Inc
Application
ANDA201546
Marketing category
ANDA
Marketing start
2011-05-20
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55312-106-082020-01-31C16284748780-19d75b9d0-22d8-f424-e053-dadaa90a57ceWestern Family ® Children's Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55312-106-08Western Family Childrens Allergy Relief120 mL in 1 BOTTLESOLUTION1202
55312-106-08Western Family Childrens Allergy Relief1 in 1 CARTONSOLUTION12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOAWESTERN FAMILY CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WESTERN FAMILY FOODS INC]2
CetirizineACTIVE MOIETYYO7261ME24WESTERN FAMILY CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WESTERN FAMILY FOODS INC]2
acetic acidINACTIVE INGREDIENTQ40Q9N063PWESTERN FAMILY CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WESTERN FAMILY FOODS INC]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXWESTERN FAMILY CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WESTERN FAMILY FOODS INC]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TWESTERN FAMILY CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WESTERN FAMILY FOODS INC]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3WESTERN FAMILY CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WESTERN FAMILY FOODS INC]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHWESTERN FAMILY CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WESTERN FAMILY FOODS INC]2
sodium acetate anhydrousINACTIVE INGREDIENTNVG71ZZ7P0WESTERN FAMILY CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WESTERN FAMILY FOODS INC]2
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4WESTERN FAMILY CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WESTERN FAMILY FOODS INC]2
waterINACTIVE INGREDIENT059QF0KO0RWESTERN FAMILY CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WESTERN FAMILY FOODS INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55312-106WESTERN FAMILY CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WESTERN FAMILY FOODS INC]2Legacy NDC, 2 package rows20140403_e933e011-6a65-4b12-97c5-1521a22fb909.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNe933e011-6a65-4b12-97c5-1521a22fb9092
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDe933e011-6a65-4b12-97c5-1521a22fb9092
1014673cetirizine HCl 1 MG/ML Oral SyrupSYe933e011-6a65-4b12-97c5-1521a22fb9092
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYe933e011-6a65-4b12-97c5-1521a22fb9092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55312-106-0855312010608120 mL in 1 BOTTLE120 mlHistorical