FDA.reportPublic FDA data

good sense allergy relief

Product NDC
0113-0612
11-digit product format
001130612
Labeler code
0113
Product ID
0113-0612_55d4d093-30f3-414d-b639-017b691d288d
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA076301
Marketing category
ANDA
Marketing start
2004-09-21
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
good sense allergy relief
Listing expiration
2027-12-31

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
0113-0612-00good sense allergy relief300 in 1 BOTTLETABLET30011
0113-0612-39good sense allergy relief1 in 1 BLISTER PACKTABLET111
0113-0612-39good sense allergy relief30 in 1 CARTONTABLET3011
0113-0612-46good sense allergy relief10 in 1 CARTONTABLET1011
0113-0612-46good sense allergy relief1 in 1 BLISTER PACKTABLET111
0113-0612-49good sense allergy relief1 in 1 BLISTER PACKTABLET111
0113-0612-49good sense allergy relief40 in 1 CARTONTABLET4011
0113-0612-58good sense allergy relief1 in 1 CARTONTABLET111
0113-0612-58good sense allergy relief40 in 1 BOTTLETABLET4011
0113-0612-60good sense allergy relief20 in 1 CARTONTABLET2011
0113-0612-60good sense allergy relief1 in 1 BLISTER PACKTABLET111
0113-0612-65good sense allergy relief30 in 1 BOTTLETABLET3011
0113-0612-65good sense allergy relief1 in 1 CARTONTABLET111
0113-0612-75good sense allergy relief1 in 1 CARTONTABLET111
0113-0612-75good sense allergy relief90 in 1 BOTTLETABLET9011
0113-0612-78good sense allergy relief1 in 1 CARTONTABLET111
0113-0612-78good sense allergy relief100 in 1 BOTTLETABLET10011
0113-0612-87good sense allergy relief1 in 1 CARTONTABLET111
0113-0612-88good sense allergy relief1 in 1 CARTONTABLET111
0113-0612-88good sense allergy relief365 in 1 BOTTLETABLET36511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0612-39EA - Each0113-061286f2a010-0d4f-4493-bf69-1aeb299cda5812012-07-24
0113-0612-46EA - Each0113-0612c28011d4-b96a-4692-a8f3-37ff09e32c0b12012-07-24
0113-0612-60EA - Each0113-0612b0068e2b-774f-4c9a-86c2-4106420c384d12012-07-24
0113-0612-65EA - Each0113-0612e8601b6e-32f6-4a48-af0b-b3da948cf88912012-07-24
0113-0612-75EA - Each0113-061216ec9377-35e0-47e4-bcd7-7d4b05309b8612020-08-06
0113-0612-88EA - Each0113-061240985875-ae6a-4250-9d9b-194af5c60e9012025-10-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNGOOD SENSE ALLERGY RELIEF (LORATADINE) TABLET [L. PERRIGO COMPANY]5
LORATADINEACTIVE MOIETY7AJO3BO7QNGOOD SENSE ALLERGY RELIEF (LORATADINE) TABLET [L. PERRIGO COMPANY]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGOOD SENSE ALLERGY RELIEF (LORATADINE) TABLET [L. PERRIGO COMPANY]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE ALLERGY RELIEF (LORATADINE) TABLET [L. PERRIGO COMPANY]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EGOOD SENSE ALLERGY RELIEF (LORATADINE) TABLET [L. PERRIGO COMPANY]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0612GOOD SENSE ALLERGY RELIEF (LORATADINE) TABLET [L. PERRIGO COMPANY]9Current NDC, Legacy NDC, 20 package rows20220217_80e8a6e8-0c5f-4065-9545-112e146d25ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN80e8a6e8-0c5f-4065-9545-112e146d25ee11
311372loratadine 10 MG Oral TabletSCD80e8a6e8-0c5f-4065-9545-112e146d25ee11
311372loratadine 10 MG 24 HR Oral TabletSY80e8a6e8-0c5f-4065-9545-112e146d25ee11
311372loratadine 10 MG 24HR Oral TabletPSN5fda4906-4133-4293-8b39-4ddcf8d398013
311372loratadine 10 MG 24HR Oral TabletPSNc288d849-59c9-4883-aac4-bae54acee8ac3
311372loratadine 10 MG Oral TabletSCD5fda4906-4133-4293-8b39-4ddcf8d398013
311372loratadine 10 MG Oral TabletSCDc288d849-59c9-4883-aac4-bae54acee8ac3
311372loratadine 10 MG 24 HR Oral TabletSY5fda4906-4133-4293-8b39-4ddcf8d398013
311372loratadine 10 MG 24 HR Oral TabletSYc288d849-59c9-4883-aac4-bae54acee8ac3
311372loratadine 10 MG 24HR Oral TabletPSN9cc3d50a-81ce-4c9d-9721-209169a332e01
311372loratadine 10 MG Oral TabletSCD9cc3d50a-81ce-4c9d-9721-209169a332e01
311372loratadine 10 MG 24 HR Oral TabletSY9cc3d50a-81ce-4c9d-9721-209169a332e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0612-0000113061200300 in 1 BOTTLEHistorical
0113-0612-390011306123930 BLISTER PACK in 1 CARTON (0113-0612-39) > 1 TABLET in 1 BLISTER PACK30 blister pack2005-11-280000-00-00NoNoCurrent
0113-0612-460011306124610 BLISTER PACK in 1 CARTON (0113-0612-46) / 1 TABLET in 1 BLISTER PACK10 blister pack2004-09-210000-00-00NoNoCurrent
0113-0612-49001130612491 in 1 BLISTER PACKHistorical
0113-0612-58001130612581 in 1 CARTONHistorical
0113-0612-600011306126020 BLISTER PACK in 1 CARTON (0113-0612-60) > 1 TABLET in 1 BLISTER PACK20 blister pack2004-09-210000-00-00NoNoCurrent
0113-0612-65001130612651 BOTTLE in 1 CARTON (0113-0612-65) / 30 TABLET in 1 BOTTLE1 bottle2004-10-060000-00-00NoNoCurrent
0113-0612-75001130612751 BOTTLE in 1 CARTON (0113-0612-75) / 90 TABLET in 1 BOTTLE1 bottle2020-06-060000-00-00NoNoCurrent
0113-0612-78001130612781 BOTTLE in 1 CARTON (0113-0612-78) / 100 TABLET in 1 BOTTLE1 bottle2025-12-15NoNoCurrent
0113-0612-87001130612871 BOTTLE in 1 CARTON (0113-0612-87) / 300 TABLET in 1 BOTTLE (0113-0612-00)1 bottle2026-01-080Current
0113-0612-88001130612881 BOTTLE in 1 CARTON (0113-0612-88) / 365 TABLET in 1 BOTTLE1 bottle2004-09-210000-00-00NoNoCurrent