FDA.reportPublic FDA data

12 hour allergy d

Product NDC
41250-728
11-digit product format
412500728
Labeler code
41250
Product ID
41250-728_dd51ee4f-bf5a-4237-9f86-6901325736a4
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine hydrochloride, pseudoephedrine hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA210719
Marketing category
ANDA
Marketing start
2020-04-07
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
12 hour 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
41250-728-5312 hour allergy d1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE14
41250-728-5312 hour allergy d12 in 1 CARTONTABLET, FILM COATED, EXTENDED RE124
41250-728-6212 hour allergy d1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE14
41250-728-6212 hour allergy d24 in 1 CARTONTABLET, FILM COATED, EXTENDED RE244

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41250-728-53EA - Each41250-7286da4747c-bfa1-402c-9198-98082d489eb912022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-72812 HOUR ALLERGY D (CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MEIJER DISTRIBUTION INC]3Current NDC, Legacy NDC, 4 package rows20200909_b7019ea1-ca3d-4ddb-8cf4-e4ca7cb95e77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014571cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNb7019ea1-ca3d-4ddb-8cf4-e4ca7cb95e774
101457112 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDb7019ea1-ca3d-4ddb-8cf4-e4ca7cb95e774
1014571cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSYb7019ea1-ca3d-4ddb-8cf4-e4ca7cb95e774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-728-534125007285312 BLISTER PACK in 1 CARTON (41250-728-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK12 blister pack2020-04-070000-00-00NoNoCurrent
41250-728-624125007286224 BLISTER PACK in 1 CARTON (41250-728-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK24 blister pack2020-04-070000-00-00NoNoCurrent