Quality Choice

Product NDC
63868-133
11-digit product format
638680133
Labeler code
63868
Product ID
63868-133_7987339d-a8ac-439e-bd02-504e46ccbb72
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
ANDA090182
Marketing category
ANDA
Marketing start
2008-04-22
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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-133-042020-01-31C16284748780-19d75b9d0-eb78-f424-e053-dadaa90a57ceQuality Choice ® Children's Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-133-04Quality Choice Childrens Allergy Relief118 mL in 1 BOTTLESOLUTION1181
63868-133-04Quality Choice Childrens Allergy Relief1 in 1 CARTONSOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-133-04ML - Milliliter63868-133aaac095d-1bf4-4bd1-a6d3-f955b4955a0412013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOAQUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
CetirizineACTIVE MOIETYYO7261ME24QUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
acetic acidINACTIVE INGREDIENTQ40Q9N063PQUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXQUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TQUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3QUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHQUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
sodium acetateINACTIVE INGREDIENT4550K0SC9BQUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
sucroseINACTIVE INGREDIENTC151H8M554QUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
waterINACTIVE INGREDIENT059QF0KO0RQUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-133QUALITY CHOICE CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1Legacy NDC, 2 package rows20130117_602358c9-d61a-4b33-9e04-1bad88fe4fed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN602358c9-d61a-4b33-9e04-1bad88fe4fed1
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD602358c9-d61a-4b33-9e04-1bad88fe4fed1
1014673cetirizine HCl 1 MG/ML Oral SyrupSY602358c9-d61a-4b33-9e04-1bad88fe4fed1
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY602358c9-d61a-4b33-9e04-1bad88fe4fed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63868-133-0463868013304118 mL in 1 BOTTLE118 mlHistorical