Allergy Relief

Product NDC
51316-064
11-digit product format
513160064
Labeler code
51316
Product ID
51316-064_a72576f6-0c54-40b4-abb2-72290c4883ac
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
CVS PHARMACY, INC
Application
ANDA213105
Marketing category
ANDA
Marketing start
2021-09-03
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
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
Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014675

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
51316-064-25Allergy Relief25 in 1 BOTTLE, PLASTICCAPSULE253
51316-064-25Allergy Relief1 in 1 BOXCAPSULE13
51316-064-40Allergy Relief40 in 1 BOTTLE, PLASTICCAPSULE403
51316-064-40Allergy Relief1 in 1 BOXCAPSULE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-064ALLERGY RELIEF (CETIRIZINE HCL) CAPSULE [CVS PHARMACY, INC]3Current NDC, Legacy NDC, 4 package rows20221108_ed8951a1-bd7e-439d-a427-685d56a9c9ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSNed8951a1-bd7e-439d-a427-685d56a9c9ad3
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCDed8951a1-bd7e-439d-a427-685d56a9c9ad3
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSYed8951a1-bd7e-439d-a427-685d56a9c9ad3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51316-064-25513160064251 BOTTLE, PLASTIC in 1 BOX (51316-064-25) / 25 CAPSULE in 1 BOTTLE, PLASTIC2021-09-030000-00-00NoNoCurrent
51316-064-40513160064401 BOTTLE, PLASTIC in 1 BOX (51316-064-40) / 40 CAPSULE in 1 BOTTLE, PLASTIC2021-09-030000-00-00NoNoCurrent