FDA.reportPublic FDA data

Allergy Relief-D

Product NDC
69842-994
11-digit product format
698420994
Labeler code
69842
Product ID
69842-994_70f4a7eb-7f9e-492b-9b6d-8fb9415f8759
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride and pseudoephedrine hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CVS PHARMACY
Application
ANDA090922
Marketing category
ANDA
Marketing start
2019-06-30
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
Allergy Relief-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
69842-994-12Allergy Relief-D2 in 1 CARTONTABLET, EXTENDED RELEASE23
69842-994-12Allergy Relief-D6 in 1 BLISTER PACKTABLET, EXTENDED RELEASE63
69842-994-24Allergy Relief-D6 in 1 BLISTER PACKTABLET, EXTENDED RELEASE63
69842-994-24Allergy Relief-D4 in 1 CARTONTABLET, EXTENDED RELEASE43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-994-12EA - Each69842-99465c1ed1d-4677-4276-9c35-874e67ef87b812021-02-05
69842-994-24EA - Each69842-9948be91792-d5be-4220-bd2d-abb8dc213f0712023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-994ALLERGY RELIEF-D (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [CVS PHARMACY]3Current NDC, Legacy NDC, 4 package rows20240117_54a158e3-f545-4a01-bf8d-e72a286d734c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014571cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN54a158e3-f545-4a01-bf8d-e72a286d734c3
101457112 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD54a158e3-f545-4a01-bf8d-e72a286d734c3
1014571cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY54a158e3-f545-4a01-bf8d-e72a286d734c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-994-12698420994122 BLISTER PACK in 1 CARTON (69842-994-12) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2019-06-300000-00-00NoNoCurrent
69842-994-24698420994244 BLISTER PACK in 1 CARTON (69842-994-24) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2019-06-300000-00-00NoNoCurrent