FDA.reportPublic FDA data

Berkley and Jensen Allergy Relief

Product NDC
68391-500
11-digit product format
683910500
Labeler code
68391
Product ID
68391-500_3a3dd69d-7cc9-43e7-9f2a-d04e7f923886
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BJWC
Application
ANDA078336
Marketing category
ANDA
Marketing start
2013-11-26
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68391-500-872026-01-29C16284748780-149896155-b429-586f-e063-e6dba90add90BJWC Allergy Relief Drug Facts
68391-500-882026-01-29C16284748780-149896155-b429-586f-e063-e6dba90add90BJWC Allergy Relief Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-500-87Berkley and Jensen Allergy Relief300 in 1 BOTTLETABLET, FILM COATED3005
68391-500-87Berkley and Jensen Allergy Relief1 in 1 PACKAGETABLET, FILM COATED15
68391-500-88Berkley and Jensen Allergy Relief1 in 1 PACKAGETABLET, FILM COATED15
68391-500-88Berkley and Jensen Allergy Relief365 in 1 BOTTLETABLET, FILM COATED3655

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOABERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]2
CETIRIZINEACTIVE MOIETYYO7261ME24BERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EBERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673BERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-500BERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [BJWC]5Legacy NDC, 4 package rows20231129_caa22bcb-6617-4724-8dcb-e63bfeef41a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNcaa22bcb-6617-4724-8dcb-e63bfeef41a95
1014678cetirizine hydrochloride 10 MG Oral TabletSCDcaa22bcb-6617-4724-8dcb-e63bfeef41a95
1014678cetirizine HCl 10 MG Oral TabletSYcaa22bcb-6617-4724-8dcb-e63bfeef41a95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-500-8768391050087300 in 1 BOTTLEHistorical
68391-500-88683910500881 BOTTLE in 1 CARTON (68391-500-88) > 365 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-11-260000-00-00NoNoCurrent