FDA.reportPublic FDA data

all day allergy

Product NDC
11822-1002
11-digit product format
118221002
Labeler code
11822
Product ID
11822-1002_6c4b2dd2-0897-4bcb-a570-6bc6f5332828
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA078336
Marketing category
ANDA
Marketing start
2021-09-14
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
all day 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
11822-1002-1all day allergy1 in 1 BLISTER PACKTABLET, FILM COATED14
11822-1002-1all day allergy14 in 1 CARTONTABLET, FILM COATED144
11822-1002-2all day allergy30 in 1 BOTTLETABLET, FILM COATED304
11822-1002-2all day allergy1 in 1 CARTONTABLET, FILM COATED14
11822-1002-3all day allergy60 in 1 BOTTLETABLET, FILM COATED604
11822-1002-3all day allergy1 in 1 CARTONTABLET, FILM COATED14
11822-1002-4all day allergy120 in 1 BOTTLETABLET, FILM COATED1204
11822-1002-4all day allergy1 in 1 CARTONTABLET, FILM COATED14
11822-1002-7all day allergy1 in 1 CARTONTABLET, FILM COATED14
11822-1002-7all day allergy300 in 1 BOTTLETABLET, FILM COATED3004
11822-1002-8all day allergy90 in 1 BOTTLETABLET, FILM COATED904
11822-1002-8all day allergy1 in 1 CARTONTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1002ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]4Current NDC, Legacy NDC, 12 package rows20230307_bcbb9f5a-10b6-4a5e-a237-d29693d78103.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNbcbb9f5a-10b6-4a5e-a237-d29693d781034
1014678cetirizine hydrochloride 10 MG Oral TabletSCDbcbb9f5a-10b6-4a5e-a237-d29693d781034
1014678cetirizine HCl 10 MG Oral TabletSYbcbb9f5a-10b6-4a5e-a237-d29693d781034

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-1002-11182210020114 BLISTER PACK in 1 CARTON (11822-1002-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK14 blister pack2021-12-070000-00-00NoNoCurrent
11822-1002-2118221002021 BOTTLE in 1 CARTON (11822-1002-2) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-140000-00-00NoNoCurrent
11822-1002-3118221002031 BOTTLE in 1 CARTON (11822-1002-3) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-070000-00-00NoNoCurrent
11822-1002-4118221002041 BOTTLE in 1 CARTON (11822-1002-4) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-140000-00-00NoNoCurrent
11822-1002-7118221002071 BOTTLE in 1 CARTON (11822-1002-7) / 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-10-19NoNoCurrent
11822-1002-8118221002081 BOTTLE in 1 CARTON (11822-1002-8) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-03-23NoNoCurrent