FDA.reportPublic FDA data

Allergy Relief

Product NDC
59779-458
11-digit product format
597790458
Labeler code
59779
Product ID
59779-458_131dd209-e1fe-4dd4-9523-8c0da50b78f4
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA078336
Marketing category
ANDA
Marketing start
2009-01-14
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Brand name suffix
Indoor and Outdoor Allergies
Listing expiration
2027-12-31

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
59779-458-00Allergy ReliefIndoor and Outdoor Allergies1 in 1 CARTONTABLET, FILM COATED114
59779-458-00Allergy ReliefIndoor and Outdoor Allergies60 in 1 BOTTLETABLET, FILM COATED6014
59779-458-01Allergy ReliefIndoor and Outdoor Allergies2 in 1 CARTONTABLET, FILM COATED214
59779-458-05Allergy ReliefIndoor and Outdoor Allergies90 in 1 BOTTLETABLET, FILM COATED9014
59779-458-06Allergy ReliefIndoor and Outdoor Allergies70 in 1 BOTTLETABLET, FILM COATED7014
59779-458-06Allergy ReliefIndoor and Outdoor Allergies1 in 1 CARTONTABLET, FILM COATED114
59779-458-13Allergy ReliefIndoor and Outdoor Allergies1 in 1 BLISTER PACKTABLET, FILM COATED114
59779-458-13Allergy ReliefIndoor and Outdoor Allergies5 in 1 CARTONTABLET, FILM COATED514
59779-458-39Allergy ReliefIndoor and Outdoor Allergies30 in 1 BOTTLETABLET, FILM COATED3014
59779-458-39Allergy ReliefIndoor and Outdoor Allergies1 in 1 CARTONTABLET, FILM COATED114
59779-458-58Allergy ReliefIndoor and Outdoor Allergies1 in 1 CARTONTABLET, FILM COATED114
59779-458-58Allergy ReliefIndoor and Outdoor Allergies40 in 1 BOTTLETABLET, FILM COATED4014
59779-458-66Allergy ReliefIndoor and Outdoor Allergies14 in 1 CARTONTABLET, FILM COATED1414
59779-458-66Allergy ReliefIndoor and Outdoor Allergies1 in 1 BLISTER PACKTABLET, FILM COATED114
59779-458-70Allergy ReliefIndoor and Outdoor Allergies2 in 1 CARTONTABLET, FILM COATED214
59779-458-70Allergy ReliefIndoor and Outdoor Allergies120 in 1 BOTTLETABLET, FILM COATED12014
59779-458-72Allergy ReliefIndoor and Outdoor Allergies2 in 1 CARTONTABLET, FILM COATED214
59779-458-72Allergy ReliefIndoor and Outdoor Allergies30 in 1 BOTTLETABLET, FILM COATED3014
59779-458-75Allergy ReliefIndoor and Outdoor Allergies90 in 1 BOTTLETABLET, FILM COATED9014
59779-458-75Allergy ReliefIndoor and Outdoor Allergies1 in 1 CARTONTABLET, FILM COATED114
59779-458-76Allergy ReliefIndoor and Outdoor Allergies1 in 1 CARTONTABLET, FILM COATED114
59779-458-76Allergy ReliefIndoor and Outdoor Allergies120 in 1 BOTTLETABLET, FILM COATED12014
59779-458-88Allergy ReliefIndoor and Outdoor Allergies365 in 1 BOTTLETABLET, FILM COATED36514
59779-458-88Allergy ReliefIndoor and Outdoor Allergies1 in 1 CARTONTABLET, FILM COATED114
59779-458-95Allergy ReliefIndoor and Outdoor Allergies1 in 1 CARTONTABLET, FILM COATED114
59779-458-95Allergy ReliefIndoor and Outdoor Allergies45 in 1 BOTTLETABLET, FILM COATED4514

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-458ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]11Current NDC, Legacy NDC, 26 package rows20230115_98f3f2c6-da18-4055-81f1-962261360f9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN98f3f2c6-da18-4055-81f1-962261360f9b14
1014678cetirizine hydrochloride 10 MG Oral TabletSCD98f3f2c6-da18-4055-81f1-962261360f9b14
1014678cetirizine HCl 10 MG Oral TabletSY98f3f2c6-da18-4055-81f1-962261360f9b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-458-00597790458001 BOTTLE in 1 CARTON (59779-458-00) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-12-19NoNoCurrent
59779-458-01597790458012 BOTTLE in 1 CARTON (59779-458-01) / 90 TABLET, FILM COATED in 1 BOTTLE (59779-458-05) 2 bottle2025-12-18NoNoCurrent
59779-458-055977904580590 in 1 BOTTLEHistorical
59779-458-06597790458061 BOTTLE in 1 CARTON (59779-458-06) > 70 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-10-050000-00-00NoNoCurrent
59779-458-13597790458135 BLISTER PACK in 1 CARTON (59779-458-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2009-02-100000-00-00NoNoCurrent
59779-458-39597790458391 BOTTLE in 1 CARTON (59779-458-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-07-250000-00-00NoNoCurrent
59779-458-58597790458581 BOTTLE in 1 CARTON (59779-458-58) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-03-210000-00-00NoNoCurrent
59779-458-665977904586614 BLISTER PACK in 1 CARTON (59779-458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK14 blister pack2013-06-140000-00-00NoNoCurrent
59779-458-70597790458702 BOTTLE in 1 CARTON (59779-458-70) / 120 TABLET, FILM COATED in 1 BOTTLE2 bottle2010-01-202026-06-30NoNoCurrent
59779-458-72597790458722 BOTTLE in 1 CARTON (59779-458-72) > 30 TABLET, FILM COATED in 1 BOTTLE2 bottle2009-01-140000-00-00NoNoCurrent
59779-458-75597790458751 BOTTLE in 1 CARTON (59779-458-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-07-030000-00-00NoNoCurrent
59779-458-76597790458761 BOTTLE in 1 CARTON (59779-458-76) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-07-090000-00-00NoNoCurrent
59779-458-88597790458881 BOTTLE in 1 CARTON (59779-458-88) / 365 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-06-260000-00-00NoNoCurrent
59779-458-95597790458951 BOTTLE in 1 CARTON (59779-458-95) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-06-272026-07-31NoNoCurrent