Allergy Relief

Product NDC
55319-962
11-digit product format
553190962
Labeler code
55319
Product ID
55319-962_d3e457d1-47cb-4ff6-bf3e-ec699baa27b8
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
ANDA209274
Marketing category
ANDA
Marketing start
2023-07-01
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
Allergy Relief
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
55319-962-05Allergy Relief5 in 1 BOTTLE, PLASTICTABLET55
55319-962-05Allergy Relief1 in 1 BOXTABLET15
55319-962-14Allergy Relief1 in 1 BLISTER PACKTABLET15
55319-962-14Allergy Relief14 in 1 CARTONTABLET145
55319-962-30Allergy Relief1 in 1 BOXTABLET15
55319-962-30Allergy Relief30 in 1 BOTTLE, PLASTICTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-962ALLERGY RELIEF (CETIRIZINE HCL) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]4Current NDC, 6 package rows20230915_b90b5ef2-5aa2-45ca-94b9-c9d9e5877e23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNb90b5ef2-5aa2-45ca-94b9-c9d9e5877e235
1014678cetirizine hydrochloride 10 MG Oral TabletSCDb90b5ef2-5aa2-45ca-94b9-c9d9e5877e235
1014678cetirizine HCl 10 MG Oral TabletSYb90b5ef2-5aa2-45ca-94b9-c9d9e5877e235

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-962-05553190962051 BOTTLE, PLASTIC in 1 BOX (55319-962-05) / 5 TABLET in 1 BOTTLE, PLASTIC2023-07-01NoNoCurrent
55319-962-145531909621414 BLISTER PACK in 1 CARTON (55319-962-14) / 1 TABLET in 1 BLISTER PACK14 blister pack2023-07-01NoNoCurrent
55319-962-30553190962301 BOTTLE, PLASTIC in 1 BOX (55319-962-30) / 30 TABLET in 1 BOTTLE, PLASTIC2023-07-01NoNoCurrent