FDA.reportPublic FDA data

Childrens Allergy Relief

Product NDC
61715-157
11-digit product format
617150157
Labeler code
61715
Product ID
61715-157_18d8d3aa-6715-45d3-a7c5-76c7aecdbf59
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Preferred Plus (Kinray)
Application
ANDA090182
Marketing category
ANDA
Marketing start
2011-09-08
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61715-157-042025-06-03C16284748780-19d75b9d0-44e3-f424-e053-dadaa90a57ce71958ab6-66cd-410b-9f56-1f20341cb729
61715-157-042020-01-31C16284748780-19d75b9d0-44e3-f424-e053-dadaa90a57ce71958ab6-66cd-410b-9f56-1f20341cb729

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOACHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [PREFERRED PLUS (KINRAY)]1
CetirizineACTIVE MOIETYYO7261ME24CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [PREFERRED PLUS (KINRAY)]1
acetic acidINACTIVE INGREDIENTQ40Q9N063PCHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [PREFERRED PLUS (KINRAY)]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [PREFERRED PLUS (KINRAY)]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TCHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [PREFERRED PLUS (KINRAY)]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [PREFERRED PLUS (KINRAY)]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHCHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [PREFERRED PLUS (KINRAY)]1
sodium acetate anhydrousINACTIVE INGREDIENTNVG71ZZ7P0CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [PREFERRED PLUS (KINRAY)]1
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [PREFERRED PLUS (KINRAY)]1
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [PREFERRED PLUS (KINRAY)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61715-157CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [PREFERRED PLUS (KINRAY)]1Legacy NDC20150418_71958ab6-66cd-410b-9f56-1f20341cb729.zip