FDA.reportPublic FDA data

good neighbor pharmacy all day allergy d

Product NDC
46122-626
11-digit product format
461220626
Labeler code
46122
Product ID
46122-626_5030343f-d4db-45fa-aa8a-ef474a5a2fa0
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride, Pseudoephedrine hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA210719
Marketing category
ANDA
Marketing start
2020-03-30
Substance
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
5; 120 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [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 neighbor pharmacy all day allergy d
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA, 6V9V2RYJ8N
Rxcui1014571

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-626-62good neighbor pharmacy all day allergy d1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13
46122-626-62good neighbor pharmacy all day allergy d24 in 1 CARTONTABLET, FILM COATED, EXTENDED RE243

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-626-62EA - Each46122-6260dcd3748-8e05-45b2-a029-d362f93ba07f12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-626GOOD NEIGHBOR PHARMACY ALL DAY ALLERGY D (CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]3Current NDC, Legacy NDC, 2 package rows20250108_a7c7b475-ca3c-4e3c-bc6b-a0e1362ded3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014571cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNa7c7b475-ca3c-4e3c-bc6b-a0e1362ded3b3
101457112 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDa7c7b475-ca3c-4e3c-bc6b-a0e1362ded3b3
1014571cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSYa7c7b475-ca3c-4e3c-bc6b-a0e1362ded3b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-626-624612206266224 BLISTER PACK in 1 CARTON (46122-626-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK24 blister pack2020-03-300000-00-00NoNoCurrent