Signature Care Childrens Allergy Relief

Product NDC
21130-189
11-digit product format
211300189
Labeler code
21130
Product ID
21130-189_4b34da58-a72e-4787-8fe3-fa13c6b91faf
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Safeway
Application
ANDA204226
Marketing category
ANDA
Marketing start
2016-04-26
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Signature Care Childrens Allergy Relief
Listing expiration
2026-12-31

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
21130-189-34Signature Care Childrens Allergy Relief1 in 1 CARTONSOLUTION12
21130-189-34Signature Care Childrens Allergy Relief240 mL in 1 BOTTLESOLUTION2402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-189SIGNATURE CARE CHILDRENS ALLERGY RELIEF (CETIRIZINE HCL) SOLUTION [SAFEWAY]2Current NDC, Legacy NDC, 2 package rows20181222_c0e2d38a-221f-4ebc-9280-3b39015b4c03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNc0e2d38a-221f-4ebc-9280-3b39015b4c032
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDc0e2d38a-221f-4ebc-9280-3b39015b4c032
1014673cetirizine HCl 1 MG/ML Oral SyrupSYc0e2d38a-221f-4ebc-9280-3b39015b4c032
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYc0e2d38a-221f-4ebc-9280-3b39015b4c032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-189-34211300189341 BOTTLE in 1 CARTON (21130-189-34) / 240 mL in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent