FDA.reportPublic FDA data

Allergy Relief

Product NDC
63941-194
11-digit product format
639410194
Labeler code
63941
Product ID
63941-194_45b23ce1-1611-b7a9-e063-6394a90a50eb
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
VALU MERCHANDISERS COMPANY
Application
ANDA209274
Marketing category
ANDA
Marketing start
2020-04-01
Marketing end
2028-01-31
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-194-01Allergy Relief14 in 1 BOTTLE, PLASTICTABLET, COATED143
63941-194-01Allergy Relief1 in 1 CARTONTABLET, COATED13
63941-194-02Allergy Relief30 in 1 BOTTLE, PLASTICTABLET, COATED303
63941-194-02Allergy Relief1 in 1 CARTONTABLET, COATED13
63941-194-05Allergy Relief60 in 1 BOTTLE, PLASTICTABLET, COATED603
63941-194-05Allergy Relief1 in 1 CARTONTABLET, COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-194ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, COATED [VALU MERCHANDISERS COMPANY]2Current NDC, Legacy NDC, 6 package rows20200912_dc66bf53-820f-40a3-b5ef-c653dd375544.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNdc66bf53-820f-40a3-b5ef-c653dd3755443
1014678cetirizine hydrochloride 10 MG Oral TabletSCDdc66bf53-820f-40a3-b5ef-c653dd3755443
1014678cetirizine HCl 10 MG Oral TabletSYdc66bf53-820f-40a3-b5ef-c653dd3755443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63941-194-01639410194011 BOTTLE, PLASTIC in 1 CARTON (63941-194-01) / 14 TABLET, COATED in 1 BOTTLE, PLASTIC2020-04-012028-01-31NoNoCurrent
63941-194-02639410194021 BOTTLE, PLASTIC in 1 CARTON (63941-194-02) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC2020-04-012028-01-31NoNoCurrent
63941-194-05639410194051 BOTTLE, PLASTIC in 1 CARTON (63941-194-05) / 60 TABLET, COATED in 1 BOTTLE, PLASTIC2020-04-012028-01-31NoNoCurrent