GOODNOW ALLERGY RELIEF

Product NDC
82501-0422
11-digit product format
825010422
Labeler code
82501
Product ID
82501-0422_5d8e3ec6-14de-463d-bea1-d40f50266304
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Gobrands, Inc
Application
ANDA078336
Marketing category
ANDA
Marketing start
2025-10-27
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
GOODNOW ALLERGY RELIEF
Listing expiration
2026-12-31

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
82501-0422-0GOODNOW ALLERGY RELIEF30 in 1 BOTTLETABLET, FILM COATED302
82501-0422-1GOODNOW ALLERGY RELIEF1 in 1 CARTONTABLET, FILM COATED12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN86ade508-8841-47d8-addb-418ecd6dc8de2
1014678cetirizine hydrochloride 10 MG Oral TabletSCD86ade508-8841-47d8-addb-418ecd6dc8de2
1014678cetirizine HCl 10 MG Oral TabletSY86ade508-8841-47d8-addb-418ecd6dc8de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82501-0422-08250104220030 in 1 BOTTLEHistorical
82501-0422-1825010422011 BOTTLE in 1 CARTON (82501-0422-1) / 30 TABLET, FILM COATED in 1 BOTTLE (82501-0422-0) 1 bottle2025-10-27NoNoHistorical