FDA.reportPublic FDA data

Good Sense all day allergy

Product NDC
0113-9458
11-digit product format
001139458
Labeler code
0113
Product ID
0113-9458_c93a5e52-e438-4421-bdca-1fcfdcdb9b98
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA078336
Marketing category
ANDA
Marketing start
2008-01-16
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
Good Sense all day allergy
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
0113-9458-04Good Sense all day allergy5 in 1 VIALTABLET, FILM COATED511
0113-9458-13Good Sense all day allergy5 in 1 CARTONTABLET, FILM COATED511
0113-9458-13Good Sense all day allergy1 in 1 BLISTER PACKTABLET, FILM COATED111
0113-9458-39Good Sense all day allergy30 in 1 BOTTLETABLET, FILM COATED3011
0113-9458-39Good Sense all day allergy1 in 1 CARTONTABLET, FILM COATED111
0113-9458-58Good Sense all day allergy1 in 1 CARTONTABLET, FILM COATED111
0113-9458-58Good Sense all day allergy40 in 1 BOTTLETABLET, FILM COATED4011
0113-9458-66Good Sense all day allergy1 in 1 BLISTER PACKTABLET, FILM COATED111
0113-9458-66Good Sense all day allergy14 in 1 CARTONTABLET, FILM COATED1411
0113-9458-75Good Sense all day allergy90 in 1 BOTTLETABLET, FILM COATED9011
0113-9458-75Good Sense all day allergy1 in 1 CARTONTABLET, FILM COATED111
0113-9458-88Good Sense all day allergy30 in 1 BOTTLETABLET, FILM COATED3011
0113-9458-88Good Sense all day allergy1 in 1 CARTONTABLET, FILM COATED111
0113-9458-95Good Sense all day allergy45 in 1 BOTTLETABLET, FILM COATED4511
0113-9458-95Good Sense all day allergy1 in 1 CARTONTABLET, FILM COATED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-9458-13EA - Each0113-9458cf7ce490-8a09-4610-976d-28425420fca612012-07-24
0113-9458-39EA - Each0113-94587241261b-47b5-449a-929f-4b4552abcf8212012-07-24
0113-9458-66EA - Each0113-94581f2d29c1-02d7-4ce1-8c65-e53954659adc12012-07-24
0113-9458-75EA - Each0113-945850fe439d-3af3-484a-9c02-e3dd1a570c5112024-02-14
0113-9458-95EA - Each0113-9458f5598fec-8cf9-40ac-9085-38ccdf80c65112018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOAGOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
CETIRIZINEACTIVE MOIETYYO7261ME24GOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GGOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEGOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EGOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3
TRIACETININACTIVE INGREDIENTXHX3C3X673GOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [L PERRIGO COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-9458GOOD SENSE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [L. PERRIGO COMPANY]9Current NDC, Legacy NDC, 15 package rows20230531_2a7a27ab-1b4c-40d1-98bf-e4297aa25682.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN2a7a27ab-1b4c-40d1-98bf-e4297aa2568211
1014678cetirizine hydrochloride 10 MG Oral TabletSCD2a7a27ab-1b4c-40d1-98bf-e4297aa2568211
1014678cetirizine HCl 10 MG Oral TabletSY2a7a27ab-1b4c-40d1-98bf-e4297aa2568211
1014678cetirizine HCl 10 MG Oral TabletPSN2f562a13-8909-4107-b135-10333707bab32
1014678cetirizine HCl 10 MG Oral TabletPSNc1a208c8-2554-4e8e-b506-aeb8e417d4442
1014678cetirizine hydrochloride 10 MG Oral TabletSCD2f562a13-8909-4107-b135-10333707bab32
1014678cetirizine hydrochloride 10 MG Oral TabletSCDc1a208c8-2554-4e8e-b506-aeb8e417d4442
1014678cetirizine HCl 10 MG Oral TabletSY2f562a13-8909-4107-b135-10333707bab32
1014678cetirizine HCl 10 MG Oral TabletSYc1a208c8-2554-4e8e-b506-aeb8e417d4442
1014678cetirizine HCl 10 MG Oral TabletPSN0827643a-29b8-487a-a158-28976d672d4d1
1014678cetirizine hydrochloride 10 MG Oral TabletSCD0827643a-29b8-487a-a158-28976d672d4d1
1014678cetirizine HCl 10 MG Oral TabletSY0827643a-29b8-487a-a158-28976d672d4d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-9458-04001139458045 in 1 VIALHistorical
0113-9458-13001139458135 BLISTER PACK in 1 CARTON (0113-9458-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2008-01-300000-00-00NoNoCurrent
0113-9458-39001139458391 BOTTLE in 1 CARTON (0113-9458-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-10-280000-00-00NoNoCurrent
0113-9458-58001139458581 in 1 CARTONHistorical
0113-9458-660011394586614 BLISTER PACK in 1 CARTON (0113-9458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK14 blister pack2008-01-160000-00-00NoNoCurrent
0113-9458-75001139458751 BOTTLE in 1 CARTON (0113-9458-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-05-10NoNoHistorical
0113-9458-88001139458881 BOTTLE in 1 CARTON (0113-9458-88) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-04-27NoNoHistorical
0113-9458-95001139458951 BOTTLE in 1 CARTON (0113-9458-95) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2010-04-080000-00-00NoNoCurrent