Allergy Relief

Product NDC
69168-392
11-digit product format
691680392
Labeler code
69168
Product ID
69168-392_9dbab14c-2a68-408a-961c-6325df359d73
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl 10 mg
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Allegiant Health
Application
ANDA078317
Marketing category
ANDA
Marketing start
2014-12-16
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
69168-392-25Allergy Relief1 in 1 CARTONCAPSULE, LIQUID FILLED11
69168-392-25Allergy Relief25 in 1 BOTTLECAPSULE, LIQUID FILLED251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-392ALLERGY RELIEF (CETIRIZINE HCL 10 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]1Current NDC, Legacy NDC, 2 package rows20190101_96952314-fd4c-455f-b55e-645c19d6e366.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN96952314-fd4c-455f-b55e-645c19d6e3661
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD96952314-fd4c-455f-b55e-645c19d6e3661
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY96952314-fd4c-455f-b55e-645c19d6e3661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-392-25691680392251 BOTTLE in 1 CARTON (69168-392-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2014-12-160000-00-00NoNoCurrent