FDA.reportPublic FDA data

Berkley and Jensen Allergy Relief

Product NDC
68391-314
11-digit product format
683910314
Labeler code
68391
Product ID
68391-314_0b39c8ab-d1f9-422e-9c99-67cd2b6cab64
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
BJWC
Application
ANDA076301
Marketing category
ANDA
Marketing start
2009-04-17
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
Berkley and Jensen 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
68391-314-79Berkley and Jensen Allergy Relief2 in 1 PACKAGETABLET27
68391-314-82Berkley and Jensen Allergy Relief200 in 1 BOTTLETABLET2007
68391-314-87Berkley and Jensen Allergy Relief1 in 1 PACKAGETABLET17
68391-314-87Berkley and Jensen Allergy Relief300 in 1 BOTTLETABLET3007
68391-314-88Berkley and Jensen Allergy Relief365 in 1 BOTTLETABLET3657
68391-314-88Berkley and Jensen Allergy Relief1 in 1 PACKAGETABLET17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNBERKLEY AND JENSEN ALLERGY RELIEF (LORATADINE) TABLET [BJWC]2
LORATADINEACTIVE MOIETY7AJO3BO7QNBERKLEY AND JENSEN ALLERGY RELIEF (LORATADINE) TABLET [BJWC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBERKLEY AND JENSEN ALLERGY RELIEF (LORATADINE) TABLET [BJWC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BERKLEY AND JENSEN ALLERGY RELIEF (LORATADINE) TABLET [BJWC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EBERKLEY AND JENSEN ALLERGY RELIEF (LORATADINE) TABLET [BJWC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-314BERKLEY AND JENSEN ALLERGY RELIEF (LORATADINE) TABLET [BJWC]6Current NDC, Legacy NDC, 6 package rows20250331_e981a0ef-08e9-4ac3-92a1-411217e0a251.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNe981a0ef-08e9-4ac3-92a1-411217e0a2517
311372loratadine 10 MG Oral TabletSCDe981a0ef-08e9-4ac3-92a1-411217e0a2517
311372loratadine 10 MG 24 HR Oral TabletSYe981a0ef-08e9-4ac3-92a1-411217e0a2517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-314-79683910314792 BOTTLE in 1 PACKAGE (68391-314-79) / 200 TABLET in 1 BOTTLE (68391-314-82) 2 bottle2025-09-04NoNoCurrent
68391-314-8268391031482200 in 1 BOTTLEHistorical
68391-314-87683910314871 in 1 PACKAGEHistorical
68391-314-88683910314881 BOTTLE in 1 PACKAGE (68391-314-88) / 365 TABLET in 1 BOTTLE1 bottle2011-09-090000-00-00NoNoCurrent