topcare allergy relief

Product NDC
36800-755
11-digit product format
368000755
Labeler code
36800
Product ID
36800-755_b03bf6f6-62bb-458f-ad7d-046defb8bf9b
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA202538
Marketing category
ANDA
Marketing start
2020-08-02
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui828269

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-755-39topcare allergy relief1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED15
36800-755-39topcare allergy relief30 in 1 CARTONCAPSULE, LIQUID FILLED305
36800-755-52topcare allergy relief10 in 1 CARTONCAPSULE, LIQUID FILLED105
36800-755-52topcare allergy relief1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-755TOPCARE ALLERGY RELIEF (LORATADINE) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 4 package rows20250227_5cc2e469-9080-4beb-804d-187fc335ccdc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828269loratadine 10 MG 24HR Oral CapsulePSN5cc2e469-9080-4beb-804d-187fc335ccdc5
828269loratadine 10 MG Oral CapsuleSCD5cc2e469-9080-4beb-804d-187fc335ccdc5
828269loratadine 10 MG 24HR Oral CapsuleSY5cc2e469-9080-4beb-804d-187fc335ccdc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-755-393680007553930 BLISTER PACK in 1 CARTON (36800-755-39) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK30 blister pack2020-08-020000-00-00NoNoCurrent
36800-755-523680007555210 BLISTER PACK in 1 CARTON (36800-755-52) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK10 blister pack2020-08-020000-00-00NoNoCurrent