FDA.reportPublic FDA data

Quality Choice Childrens Allergy Relief

Product NDC
63868-093
11-digit product format
638680093
Labeler code
63868
Product ID
63868-093_f4c39cea-9a5e-45f4-bcf8-c372ef81ce86
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Chain Drug Marketing Association Inc.
Application
ANDA090182
Marketing category
ANDA
Marketing start
2011-09-08
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 mg/mL
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
63868-093-082025-11-20C16284748780-19d75b9cf-e40b-f424-e053-dadaa90a57ceb0808884-e588-404c-aca3-2c91cb220d9b
63868-093-082020-01-31C16284748780-19d75b9cf-e40b-f424-e053-dadaa90a57ceb0808884-e588-404c-aca3-2c91cb220d9b

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOAQUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION INC.]2
CetirizineACTIVE MOIETYYO7261ME24QUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION INC.]2
acetic acidINACTIVE INGREDIENTQ40Q9N063PQUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXQUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TQUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3QUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHQUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION INC.]2
sodium acetate anhydrousINACTIVE INGREDIENTNVG71ZZ7P0QUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION INC.]2
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4QUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION INC.]2
waterINACTIVE INGREDIENT059QF0KO0RQUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-093QUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION INC.]2Legacy NDC20130131_b0808884-e588-404c-aca3-2c91cb220d9b.zip