CHILDRENS ALLERGY RELIEF

Product NDC
63868-865
11-digit product format
638680865
Labeler code
63868
Product ID
63868-865_434f1b5b-1e26-406a-a5e2-df310b74e993
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
C.D.M.A., Inc.
Application
ANDA090750
Marketing category
ANDA
Marketing start
2014-11-20
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 mg/mL
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
CHILDRENS ALLERGY RELIEF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014673

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-865-04CHILDRENS ALLERGY RELIEF120 mL in 1 BOTTLESOLUTION1204
63868-865-04CHILDRENS ALLERGY RELIEF1 in 1 CARTONSOLUTION14

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-865CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [C.D.M.A., INC.]4Current NDC, Legacy NDC, 2 package rows20201215_b4feed95-86ca-411c-99b5-773e485e752f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNb4feed95-86ca-411c-99b5-773e485e752f4
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDb4feed95-86ca-411c-99b5-773e485e752f4
1014673cetirizine HCl 1 MG/ML Oral SyrupSYb4feed95-86ca-411c-99b5-773e485e752f4
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYb4feed95-86ca-411c-99b5-773e485e752f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-865-04638680865041 BOTTLE in 1 CARTON (63868-865-04) / 120 mL in 1 BOTTLE1 bottle2014-11-200000-00-00NoNoCurrent