Good Sense Childrens All Day Allergy

Product NDC
0113-0503
11-digit product format
001130503
Labeler code
0113
Product ID
0113-0503_b22f5e62-c619-46b6-9158-b097ba044ba8
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA204226
Marketing category
ANDA
Marketing start
2016-01-11
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Good Sense Childrens All Day Allergy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/5mL

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
0113-0503-01Good Sense Childrens All Day Allergy240 mL in 1 BOTTLESOLUTION2404
0113-0503-26Good Sense Childrens All Day Allergy1 in 1 CARTONSOLUTION14
0113-0503-26Good Sense Childrens All Day Allergy118 mL in 1 BOTTLESOLUTION1184
0113-0503-34Good Sense Childrens All Day Allergy1 in 1 CARTONSOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0503-26ML - Milliliter0113-0503274a9c29-2d55-483e-9335-8f112c6b372312017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0503GOOD SENSE CHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [L. PERRIGO COMPANY]3Current NDC, Legacy NDC, 4 package rows20250501_e56edd0e-4873-41bc-a727-05c02ec943ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNe56edd0e-4873-41bc-a727-05c02ec943ed4
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDe56edd0e-4873-41bc-a727-05c02ec943ed4
1014673cetirizine HCl 1 MG/ML Oral SyrupSYe56edd0e-4873-41bc-a727-05c02ec943ed4
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYe56edd0e-4873-41bc-a727-05c02ec943ed4
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN6a7c4dff-66c6-4d0c-af10-d908c65a43be3
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN8c99c767-6b46-4819-89df-c02f478a45be3
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD6a7c4dff-66c6-4d0c-af10-d908c65a43be3
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD8c99c767-6b46-4819-89df-c02f478a45be3
1014673cetirizine HCl 1 MG/ML Oral SyrupSY6a7c4dff-66c6-4d0c-af10-d908c65a43be3
1014673cetirizine HCl 1 MG/ML Oral SyrupSY8c99c767-6b46-4819-89df-c02f478a45be3
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY6a7c4dff-66c6-4d0c-af10-d908c65a43be3
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY8c99c767-6b46-4819-89df-c02f478a45be3
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN8cf4615b-47f8-4b92-b0cd-16c380ad23201
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD8cf4615b-47f8-4b92-b0cd-16c380ad23201
1014673cetirizine HCl 1 MG/ML Oral SyrupSY8cf4615b-47f8-4b92-b0cd-16c380ad23201
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY8cf4615b-47f8-4b92-b0cd-16c380ad23201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0503-0100113050301240 mL in 1 BOTTLE240 mlHistorical
0113-0503-26001130503261 BOTTLE in 1 CARTON (0113-0503-26) / 118 mL in 1 BOTTLE1 bottle2016-01-110000-00-00NoNoCurrent
0113-0503-34001130503341 BOTTLE in 1 CARTON (0113-0503-34) / 240 mL in 1 BOTTLE (0113-0503-01) 1 bottle2026-01-08NoNoHistorical