FDA.reportPublic FDA data

24 hour allergy

Product NDC
41250-458
11-digit product format
412500458
Labeler code
41250
Product ID
41250-458_18b74fff-8596-4050-93ee-4f15e6811de4
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA078336
Marketing category
ANDA
Marketing start
1997-07-07
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
24 hour allergy
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
41250-458-1324 hour allergy1 in 1 BLISTER PACKTABLET, FILM COATED18
41250-458-1324 hour allergy5 in 1 CARTONTABLET, FILM COATED58
41250-458-3924 hour allergy30 in 1 BOTTLETABLET, FILM COATED308
41250-458-3924 hour allergy1 in 1 CARTONTABLET, FILM COATED18
41250-458-5824 hour allergy40 in 1 BOTTLETABLET, FILM COATED408
41250-458-5824 hour allergy1 in 1 CARTONTABLET, FILM COATED18
41250-458-6624 hour allergy1 in 1 BLISTER PACKTABLET, FILM COATED18
41250-458-6624 hour allergy14 in 1 CARTONTABLET, FILM COATED148
41250-458-7224 hour allergy60 in 1 BOTTLETABLET, FILM COATED608
41250-458-7224 hour allergy1 in 1 CARTONTABLET, FILM COATED18
41250-458-7524 hour allergy2 in 1 CARTONTABLET, FILM COATED28
41250-458-7524 hour allergy45 in 1 BOTTLETABLET, FILM COATED458
41250-458-8724 hour allergy1 in 1 CARTONTABLET, FILM COATED18
41250-458-8724 hour allergy300 in 1 BOTTLETABLET, FILM COATED3008
41250-458-9524 hour allergy45 in 1 BOTTLETABLET, FILM COATED458
41250-458-9524 hour allergy1 in 1 CARTONTABLET, FILM COATED18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41250-458-75EA - Each41250-458cc289dad-83e8-4d1b-bbf8-3ca8035c935b12017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOA24 HOUR ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]2
CETIRIZINEACTIVE MOIETYYO7261ME2424 HOUR ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO24 HOUR ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5X24 HOUR ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I3024 HOUR ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IE24 HOUR ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A24 HOUR ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94E24 HOUR ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ24 HOUR ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP24 HOUR ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]2
TRIACETININACTIVE INGREDIENTXHX3C3X67324 HOUR ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-45824 HOUR ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]7Current NDC, Legacy NDC, 16 package rows20231207_2b03c026-3e8a-4283-981f-965bc084c03d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN2b03c026-3e8a-4283-981f-965bc084c03d8
1014678cetirizine hydrochloride 10 MG Oral TabletSCD2b03c026-3e8a-4283-981f-965bc084c03d8
1014678cetirizine HCl 10 MG Oral TabletSY2b03c026-3e8a-4283-981f-965bc084c03d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-458-13412500458135 BLISTER PACK in 1 CARTON (41250-458-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2020-10-130000-00-00NoNoCurrent
41250-458-39412500458391 BOTTLE in 1 CARTON (41250-458-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-12-190000-00-00NoNoCurrent
41250-458-58412500458581 BOTTLE in 1 CARTON (41250-458-58) > 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-02-270000-00-00NoNoCurrent
41250-458-664125004586614 BLISTER PACK in 1 CARTON (41250-458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK14 blister pack2008-01-110000-00-00NoNoCurrent
41250-458-72412500458721 BOTTLE in 1 CARTON (41250-458-72) > 60 TABLET, FILM COATED in 1 BOTTLE1 bottle1997-07-070000-00-00NoNoCurrent
41250-458-75412500458752 BOTTLE in 1 CARTON (41250-458-75) / 45 TABLET, FILM COATED in 1 BOTTLE2 bottle2008-08-150000-00-00NoNoCurrent
41250-458-87412500458871 BOTTLE in 1 CARTON (41250-458-87) / 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-08-270000-00-00NoNoCurrent
41250-458-95412500458951 BOTTLE in 1 CARTON (41250-458-95) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-08-150000-00-00NoNoCurrent