FDA.reportPublic FDA data

Childrens Cetirizine Hydrochloride

Product NDC
83939-0009
11-digit product format
839390009
Labeler code
83939
Product ID
83939-0009_42a116a8-78f8-3c52-e063-6394a90a31d9
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
VERITYRX, LLC
Application
ANDA090182
Marketing category
ANDA
Marketing start
2011-09-08
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 Cetirizine Hydrochloride
Brand name suffix
Sugar Free Grape
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
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83939-0009-1Childrens Cetirizine HydrochlorideSugar Free Grape5 mL in 1 CUP, UNIT-DOSESOLUTION51
83939-0009-2Childrens Cetirizine HydrochlorideSugar Free Grape5 mL in 1 CUP, UNIT-DOSESOLUTION51
83939-0009-2Childrens Cetirizine HydrochlorideSugar Free Grape10 in 1 BOX, UNIT-DOSESOLUTION101
83939-0009-3Childrens Cetirizine HydrochlorideSugar Free Grape40 in 1 BOX, UNIT-DOSESOLUTION401
83939-0009-3Childrens Cetirizine HydrochlorideSugar Free Grape5 mL in 1 CUP, UNIT-DOSESOLUTION51
83939-0009-4Childrens Cetirizine HydrochlorideSugar Free Grape50 in 1 BOX, UNIT-DOSESOLUTION501
83939-0009-4Childrens Cetirizine HydrochlorideSugar Free Grape5 mL in 1 CUP, UNIT-DOSESOLUTION51
83939-0009-5Childrens Cetirizine HydrochlorideSugar Free Grape5 mL in 1 CUP, UNIT-DOSESOLUTION51
83939-0009-5Childrens Cetirizine HydrochlorideSugar Free Grape100 in 1 BOX, UNIT-DOSESOLUTION1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN42a1168e-e2cd-a1e5-e063-6294a90ab3b61
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD42a1168e-e2cd-a1e5-e063-6294a90ab3b61
1014673cetirizine HCl 1 MG/ML Oral SyrupSY42a1168e-e2cd-a1e5-e063-6294a90ab3b61
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY42a1168e-e2cd-a1e5-e063-6294a90ab3b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83939-0009-1839390009015 mL in 1 CUP, UNIT-DOSE (83939-0009-1) 5 ml2025-11-03NoNoHistorical
83939-0009-28393900090210 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (83939-0009-2) / 5 mL in 1 CUP, UNIT-DOSE2025-11-10NoNoHistorical
83939-0009-38393900090340 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (83939-0009-3) / 5 mL in 1 CUP, UNIT-DOSE2025-11-10NoNoHistorical
83939-0009-48393900090450 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (83939-0009-4) / 5 mL in 1 CUP, UNIT-DOSE2025-11-10NoNoHistorical
83939-0009-583939000905100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (83939-0009-5) / 5 mL in 1 CUP, UNIT-DOSE2025-11-10NoNoHistorical