Childrens Cetirizine Hydrochloride

Product NDC
51672-2102
11-digit product format
516722102
Labeler code
51672
Product ID
51672-2102_38f727a4-1153-9087-e063-6294a90ae97b
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
51672-2102-1Childrens Cetirizine Hydrochloride Sugar Free Grape1 in 1 CARTONSOLUTION16
51672-2102-1Childrens Cetirizine Hydrochloride Sugar Free Grape240 mL in 1 BOTTLESOLUTION2406
51672-2102-2Childrens Cetirizine Hydrochloride Sugar Free Grape2 in 1 CARTONSOLUTION26
51672-2102-2Childrens Cetirizine Hydrochloride Sugar Free Grape120 mL in 1 BOTTLESOLUTION1206
51672-2102-4Childrens Cetirizine Hydrochloride Sugar Free Grape1 in 1 CARTONSOLUTION16
51672-2102-4Childrens Cetirizine Hydrochloride Sugar Free Grape60 mL in 1 BOTTLESOLUTION606
51672-2102-7Childrens Cetirizine Hydrochloride Sugar Free Grape240 mL in 1 BOTTLESOLUTION2406
51672-2102-7Childrens Cetirizine Hydrochloride Sugar Free Grape2 in 1 CARTONSOLUTION26
51672-2102-8Childrens Cetirizine Hydrochloride Sugar Free Grape1 in 1 CARTONSOLUTION16
51672-2102-8Childrens Cetirizine Hydrochloride Sugar Free Grape120 mL in 1 BOTTLESOLUTION1206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2102-8ML - Milliliter51672-21029c5ff033-2296-40e3-82ef-17b9cdcc2a1e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOACHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE (CETIRIZINE HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]3
CetirizineACTIVE MOIETYYO7261ME24CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE (CETIRIZINE HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]3
acetic acidINACTIVE INGREDIENTQ40Q9N063PCHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE (CETIRIZINE HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE (CETIRIZINE HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9TCHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE (CETIRIZINE HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE (CETIRIZINE HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHCHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE (CETIRIZINE HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]3
sodium acetate anhydrousINACTIVE INGREDIENTNVG71ZZ7P0CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE (CETIRIZINE HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]3
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE (CETIRIZINE HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE (CETIRIZINE HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2102CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE (CETIRIZINE HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 10 package rows20210422_54d72d7a-1f5b-4b36-bf76-ab7aef6243ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN54d72d7a-1f5b-4b36-bf76-ab7aef6243ab6
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD54d72d7a-1f5b-4b36-bf76-ab7aef6243ab6
1014673cetirizine HCl 1 MG/ML Oral SyrupSY54d72d7a-1f5b-4b36-bf76-ab7aef6243ab6
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY54d72d7a-1f5b-4b36-bf76-ab7aef6243ab6
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN016b66fd-dde9-4f13-afaf-a8aafbdeed1a4
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD016b66fd-dde9-4f13-afaf-a8aafbdeed1a4
1014673cetirizine HCl 1 MG/ML Oral SyrupSY016b66fd-dde9-4f13-afaf-a8aafbdeed1a4
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY016b66fd-dde9-4f13-afaf-a8aafbdeed1a4
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN42a1168e-e2cd-a1e5-e063-6294a90ab3b61
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN582db483-394e-4c00-8522-4041a11696e41
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD42a1168e-e2cd-a1e5-e063-6294a90ab3b61
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD582db483-394e-4c00-8522-4041a11696e41
1014673cetirizine HCl 1 MG/ML Oral SyrupSY42a1168e-e2cd-a1e5-e063-6294a90ab3b61
1014673cetirizine HCl 1 MG/ML Oral SyrupSY582db483-394e-4c00-8522-4041a11696e41
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY42a1168e-e2cd-a1e5-e063-6294a90ab3b61
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY582db483-394e-4c00-8522-4041a11696e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2102-1516722102011 BOTTLE in 1 CARTON (51672-2102-1) / 240 mL in 1 BOTTLE1 bottle2011-09-080000-00-00NoNoCurrent
51672-2102-2516722102022 BOTTLE in 1 CARTON (51672-2102-2) / 120 mL in 1 BOTTLE2 bottle2011-09-080000-00-00NoNoCurrent
51672-2102-4516722102041 BOTTLE in 1 CARTON (51672-2102-4) / 60 mL in 1 BOTTLE1 bottle2011-09-080000-00-00NoNoCurrent
51672-2102-7516722102072 BOTTLE in 1 CARTON (51672-2102-7) / 240 mL in 1 BOTTLE2 bottle2011-09-080000-00-00NoNoCurrent
51672-2102-8516722102081 BOTTLE in 1 CARTON (51672-2102-8) / 120 mL in 1 BOTTLE1 bottle2011-09-080000-00-00NoNoCurrent