FDA.reportPublic FDA data

TopCare Allergy Relief

Product NDC
36800-612
11-digit product format
368000612
Labeler code
36800
Product ID
36800-612_9fd9c4c8-9520-470a-9deb-e050233a6e92
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA076301
Marketing category
ANDA
Marketing start
2005-01-25
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TopCare Allergy Relief
Brand name suffix
24 hour
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-612-03TopCare Allergy Relief24 hour1 in 1 CARTONTABLET19
36800-612-03TopCare Allergy Relief24 hour70 in 1 BOTTLETABLET709
36800-612-46TopCare Allergy Relief24 hour10 in 1 CARTONTABLET109
36800-612-46TopCare Allergy Relief24 hour1 in 1 BLISTER PACKTABLET19
36800-612-58TopCare Allergy Relief24 hour1 in 1 CARTONTABLET19
36800-612-58TopCare Allergy Relief24 hour40 in 1 BOTTLETABLET409
36800-612-65TopCare Allergy Relief24 hour30 in 1 BOTTLETABLET309
36800-612-65TopCare Allergy Relief24 hour1 in 1 CARTONTABLET19
36800-612-72TopCare Allergy Relief24 hour1 in 1 CARTONTABLET19
36800-612-72TopCare Allergy Relief24 hour60 in 1 BOTTLETABLET609
36800-612-76TopCare Allergy Relief24 hour120 in 1 BOTTLETABLET1209
36800-612-76TopCare Allergy Relief24 hour1 in 1 CARTONTABLET19
36800-612-87TopCare Allergy Relief24 hour1 in 1 CARTONTABLET19
36800-612-87TopCare Allergy Relief24 hour300 in 1 BOTTLETABLET3009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-612-46EA - Each36800-61299bcf7c3-81c2-4c51-9922-d48a2d708a2312012-07-24
36800-612-65EA - Each36800-6122ec8642a-4d63-404a-89bb-70688adc5f6512012-07-24
36800-612-72EA - Each36800-61257de3a43-5539-4bef-8432-51fdceaa11f212012-07-24
36800-612-76EA - Each36800-6127ebe104e-0745-4256-9bba-1c5f903c85cc12012-07-24
36800-612-87EA - Each36800-612789493b0-6107-495e-8c23-44fe27313a3f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNTOPCARE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [TOPCO ASSOCIATES LLC]3
LORATADINEACTIVE MOIETY7AJO3BO7QNTOPCARE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [TOPCO ASSOCIATES LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPCARE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [TOPCO ASSOCIATES LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPCARE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [TOPCO ASSOCIATES LLC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ETOPCARE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [TOPCO ASSOCIATES LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-612TOPCARE ALLERGY RELIEF 24 HOUR (LORATADINE) TABLET [TOPCO ASSOCIATES LLC]9Current NDC, Legacy NDC, 14 package rows20250331_a500aebf-a020-4da9-afdb-a699077cb8e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNa500aebf-a020-4da9-afdb-a699077cb8e19
311372loratadine 10 MG Oral TabletSCDa500aebf-a020-4da9-afdb-a699077cb8e19
311372loratadine 10 MG 24 HR Oral TabletSYa500aebf-a020-4da9-afdb-a699077cb8e19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-612-03368000612031 BOTTLE in 1 CARTON (36800-612-03) / 70 TABLET in 1 BOTTLE1 bottle2014-03-050000-00-00NoNoCurrent
36800-612-463680006124610 BLISTER PACK in 1 CARTON (36800-612-46) / 1 TABLET in 1 BLISTER PACK10 blister pack2005-01-280000-00-00NoNoCurrent
36800-612-58368000612581 BOTTLE in 1 CARTON (36800-612-58) / 40 TABLET in 1 BOTTLE1 bottle2014-02-190000-00-00NoNoCurrent
36800-612-65368000612651 BOTTLE in 1 CARTON (36800-612-65) / 30 TABLET in 1 BOTTLE1 bottle2005-01-250000-00-00NoNoCurrent
36800-612-72368000612721 in 1 CARTONHistorical
36800-612-76368000612761 BOTTLE in 1 CARTON (36800-612-76) > 120 TABLET in 1 BOTTLE1 bottle2009-12-180000-00-00NoNoCurrent
36800-612-87368000612871 BOTTLE in 1 CARTON (36800-612-87) / 300 TABLET in 1 BOTTLE1 bottle2009-12-180000-00-00NoNoCurrent