FDA.reportPublic FDA data

Good Sense all day allergy

Product NDC
68788-4023
11-digit product format
687884023
Labeler code
68788
Product ID
68788-4023_0827643a-29b8-487a-a158-28976d672d4d
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc
Application
ANDA078336
Marketing category
ANDA
Marketing start
2025-09-12
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Good Sense all day allergy
Listing expiration
2026-12-31

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
68788-4023-3Good Sense all day allergy30 in 1 BOTTLETABLET, FILM COATED301
68788-4023-6Good Sense all day allergy60 in 1 BOTTLETABLET, FILM COATED601
68788-4023-9Good Sense all day allergy90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4023-3EA - Each68788-40230b1b9205-069a-4495-bb33-b1ad6e79278812025-11-13
68788-4023-6EA - Each68788-40231b489f15-7b6c-47a4-8b73-03846ca444c712025-11-13
68788-4023-9EA - Each68788-4023544f59dd-d5c4-4134-90e0-50373829979112025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionMarketing startSampleExclude flagStatus
68788-4023-36878840230330 TABLET, FILM COATED in 1 BOTTLE (68788-4023-3) 2025-09-12NoNoCurrent
68788-4023-66878840230660 TABLET, FILM COATED in 1 BOTTLE (68788-4023-6) 2025-09-12NoNoCurrent
68788-4023-96878840230990 TABLET, FILM COATED in 1 BOTTLE (68788-4023-9) 2025-09-12NoNoCurrent