FDA.reportPublic FDA data

TopCare All Day Allergy

Product NDC
36800-458
11-digit product format
368000458
Labeler code
36800
Product ID
36800-458_dc4e4803-536c-4a2b-9faa-e307a66eb91a
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA078336
Marketing category
ANDA
Marketing start
2008-01-10
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
TopCare 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
36800-458-06TopCare All Day Allergy1 in 1 CARTONTABLET, FILM COATED18
36800-458-06TopCare All Day Allergy70 in 1 BOTTLETABLET, FILM COATED708
36800-458-13TopCare All Day Allergy5 in 1 CARTONTABLET, FILM COATED58
36800-458-13TopCare All Day Allergy1 in 1 BLISTER PACKTABLET, FILM COATED18
36800-458-39TopCare All Day Allergy1 in 1 CARTONTABLET, FILM COATED18
36800-458-39TopCare All Day Allergy30 in 1 BOTTLETABLET, FILM COATED308
36800-458-47TopCare All Day Allergy1 in 1 CARTONTABLET, FILM COATED18
36800-458-47TopCare All Day Allergy150 in 1 BOTTLETABLET, FILM COATED1508
36800-458-58TopCare All Day Allergy40 in 1 BOTTLETABLET, FILM COATED408
36800-458-58TopCare All Day Allergy1 in 1 CARTONTABLET, FILM COATED18
36800-458-66TopCare All Day Allergy14 in 1 CARTONTABLET, FILM COATED148
36800-458-66TopCare All Day Allergy1 in 1 BLISTER PACKTABLET, FILM COATED18
36800-458-72TopCare All Day Allergy1 in 1 CARTONTABLET, FILM COATED18
36800-458-72TopCare All Day Allergy60 in 1 BOTTLETABLET, FILM COATED608
36800-458-75TopCare All Day Allergy1 in 1 CARTONTABLET, FILM COATED18
36800-458-75TopCare All Day Allergy90 in 1 BOTTLETABLET, FILM COATED908
36800-458-87TopCare All Day Allergy300 in 1 BOTTLETABLET, FILM COATED3008
36800-458-87TopCare All Day Allergy1 in 1 CARTONTABLET, FILM COATED18
36800-458-95TopCare All Day Allergy1 in 1 CARTONTABLET, FILM COATED18
36800-458-95TopCare All Day Allergy45 in 1 BOTTLETABLET, FILM COATED458

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-458TOPCARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]7Current NDC, Legacy NDC, 20 package rows20211201_f2919aad-9ed4-40b8-b233-4aec06df33ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNf2919aad-9ed4-40b8-b233-4aec06df33ea8
1014678cetirizine hydrochloride 10 MG Oral TabletSCDf2919aad-9ed4-40b8-b233-4aec06df33ea8
1014678cetirizine HCl 10 MG Oral TabletSYf2919aad-9ed4-40b8-b233-4aec06df33ea8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-458-06368000458061 BOTTLE in 1 CARTON (36800-458-06) > 70 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-03-200000-00-00NoNoCurrent
36800-458-13368000458135 BLISTER PACK in 1 CARTON (36800-458-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2008-02-120000-00-00NoNoCurrent
36800-458-39368000458391 BOTTLE in 1 CARTON (36800-458-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-04-160000-00-00NoNoCurrent
36800-458-47368000458471 BOTTLE in 1 CARTON (36800-458-47) / 150 TABLET, FILM COATED in 1 BOTTLE1 bottle2010-05-260000-00-00NoNoCurrent
36800-458-58368000458581 BOTTLE in 1 CARTON (36800-458-58) > 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-02-050000-00-00NoNoCurrent
36800-458-663680004586614 BLISTER PACK in 1 CARTON (36800-458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK14 blister pack2008-01-100000-00-00NoNoCurrent
36800-458-72368000458721 BOTTLE in 1 CARTON (36800-458-72) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-01-280000-00-00NoNoCurrent
36800-458-75368000458751 BOTTLE in 1 CARTON (36800-458-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-09-190000-00-00NoNoCurrent
36800-458-87368000458871 BOTTLE in 1 CARTON (36800-458-87) / 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2010-04-280000-00-00NoNoCurrent
36800-458-95368000458951 BOTTLE in 1 CARTON (36800-458-95) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-09-080000-00-00NoNoCurrent