FDA.reportPublic FDA data

CHILDRENS ALLERGY RELIEF

Product NDC
69230-316
11-digit product format
692300316
Labeler code
69230
Product ID
69230-316_14a303ce-ffb0-acd3-e063-6294a90a9327
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Camber Consumer Care Inc
Application
ANDA210622
Marketing category
ANDA
Marketing start
2019-03-13
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
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69230-316-11CHILDRENS ALLERGY RELIEF1 in 1 CARTONSOLUTION12
69230-316-11CHILDRENS ALLERGY RELIEF118 mL in 1 BOTTLESOLUTION1182

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-316-11ML - Milliliter69230-316df4f780c-3b4f-4d07-a2b4-828a2bff508d12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-316CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [CAMBER CONSUMER CARE INC]2Current NDC, Legacy NDC, 2 package rows20240328_941e4aa9-6388-424c-87ad-3ea2ec5aafea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNa6492645-8438-4e82-aa31-7e5b4bccb2208
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDa6492645-8438-4e82-aa31-7e5b4bccb2208
1014673cetirizine HCl 1 MG/ML Oral SyrupSYa6492645-8438-4e82-aa31-7e5b4bccb2208
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYa6492645-8438-4e82-aa31-7e5b4bccb2208
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN941e4aa9-6388-424c-87ad-3ea2ec5aafea2
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD941e4aa9-6388-424c-87ad-3ea2ec5aafea2
1014673cetirizine HCl 1 MG/ML Oral SyrupSY941e4aa9-6388-424c-87ad-3ea2ec5aafea2
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY941e4aa9-6388-424c-87ad-3ea2ec5aafea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-316-11692300316111 BOTTLE in 1 CARTON (69230-316-11) / 118 mL in 1 BOTTLE1 bottle2019-03-130000-00-00NoNoCurrent