Allergy Relief

Product NDC
85828-194
11-digit product format
858280194
Labeler code
85828
Product ID
85828-194_5256dd4a-ca7c-1585-e063-6394a90a0926
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Grocery Outlet, Inc
Application
ANDA209274
Marketing category
ANDA
Marketing start
2026-02-18
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

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
85828-194-14Allergy Relief1 in 1 CARTONTABLET, COATED13
85828-194-14Allergy Relief30 in 1 BOTTLE, PLASTICTABLET, COATED303

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN441d049c-8844-955e-e063-6294a90a666d3
1014678cetirizine hydrochloride 10 MG Oral TabletSCD441d049c-8844-955e-e063-6294a90a666d3
1014678cetirizine HCl 10 MG Oral TabletSY441d049c-8844-955e-e063-6294a90a666d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85828-194-14858280194141 BOTTLE, PLASTIC in 1 CARTON (85828-194-14) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC2026-02-18NoNoCurrent