FDA.reportPublic FDA data

All Day Allergy

Product NDC
42507-458
11-digit product format
425070458
Labeler code
42507
Product ID
42507-458_a9ba17ab-f223-4850-a8c4-96ae247ed081
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
HyVee Inc
Application
ANDA078336
Marketing category
ANDA
Marketing start
1997-08-28
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
All Day Allergy
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
42507-458-00All Day Allergy300 in 1 BOTTLETABLET, FILM COATED3006
42507-458-06All Day Allergy70 in 1 BOTTLETABLET, FILM COATED706
42507-458-06All Day Allergy1 in 1 CARTONTABLET, FILM COATED16
42507-458-30All Day Allergy30 in 1 BOTTLETABLET, FILM COATED306
42507-458-39All Day Allergy1 in 1 CARTONTABLET, FILM COATED16
42507-458-45All Day Allergy45 in 1 BOTTLETABLET, FILM COATED456
42507-458-60All Day Allergy60 in 1 BOTTLETABLET, FILM COATED606
42507-458-66All Day Allergy1 in 1 BLISTER PACKTABLET, FILM COATED16
42507-458-66All Day Allergy14 in 1 CARTONTABLET, FILM COATED146
42507-458-72All Day Allergy1 in 1 CARTONTABLET, FILM COATED16
42507-458-75All Day Allergy1 in 1 CARTONTABLET, FILM COATED16
42507-458-87All Day Allergy1 in 1 CARTONTABLET, FILM COATED16
42507-458-90All Day Allergy90 in 1 BOTTLETABLET, FILM COATED906
42507-458-95All Day Allergy1 in 1 CARTONTABLET, FILM COATED16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOAALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [HYVEE INC]3
CETIRIZINEACTIVE MOIETYYO7261ME24ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [HYVEE INC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [HYVEE INC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [HYVEE INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [HYVEE INC]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [HYVEE INC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [HYVEE INC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [HYVEE INC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [HYVEE INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [HYVEE INC]3
TRIACETININACTIVE INGREDIENTXHX3C3X673ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [HYVEE INC]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN8889af37-8345-4358-994d-7d8b847f48746
1014678cetirizine hydrochloride 10 MG Oral TabletSCD8889af37-8345-4358-994d-7d8b847f48746
1014678cetirizine HCl 10 MG Oral TabletSY8889af37-8345-4358-994d-7d8b847f48746

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-458-0042507045800300 in 1 BOTTLEHistorical
42507-458-064250704580670 in 1 BOTTLEHistorical
42507-458-304250704583030 in 1 BOTTLEHistorical
42507-458-39425070458391 BOTTLE in 1 CARTON (42507-458-39) / 30 TABLET, FILM COATED in 1 BOTTLE (42507-458-30) 1 bottle2008-12-08NoNoHistorical
42507-458-454250704584545 in 1 BOTTLEHistorical
42507-458-604250704586060 in 1 BOTTLEHistorical
42507-458-66425070458661 in 1 BLISTER PACKHistorical
42507-458-72425070458721 BOTTLE in 1 CARTON (42507-458-72) / 60 TABLET, FILM COATED in 1 BOTTLE (42507-458-60) 1 bottle1997-08-28NoNoHistorical
42507-458-75425070458751 BOTTLE in 1 CARTON (42507-458-75) / 90 TABLET, FILM COATED in 1 BOTTLE (42507-458-90) 1 bottle2009-06-27NoNoHistorical
42507-458-87425070458871 BOTTLE in 1 CARTON (42507-458-87) / 300 TABLET, FILM COATED in 1 BOTTLE (42507-458-00) 1 bottle2026-01-28NoNoHistorical
42507-458-904250704589090 in 1 BOTTLEHistorical
42507-458-95425070458951 BOTTLE in 1 CARTON (42507-458-95) / 45 TABLET, FILM COATED in 1 BOTTLE (42507-458-45) 1 bottle2009-01-19NoNoHistorical