FDA.reportPublic FDA data

Equaline all day allergy

Product NDC
41163-458
11-digit product format
411630458
Labeler code
41163
Product ID
41163-458_6e7bab3d-af1a-4b74-921d-99aca2aa0fd3
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA078336
Marketing category
ANDA
Marketing start
2008-01-23
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
Equaline 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
41163-458-39Equaline all day allergy30 in 1 BOTTLETABLET, FILM COATED309
41163-458-39Equaline all day allergy1 in 1 CARTONTABLET, FILM COATED19
41163-458-58Equaline all day allergy40 in 1 BOTTLETABLET, FILM COATED409
41163-458-58Equaline all day allergy1 in 1 CARTONTABLET, FILM COATED19
41163-458-66Equaline all day allergy14 in 1 CARTONTABLET, FILM COATED149
41163-458-66Equaline all day allergy1 in 1 BLISTER PACKTABLET, FILM COATED19
41163-458-72Equaline all day allergy1 in 1 CARTONTABLET, FILM COATED19
41163-458-72Equaline all day allergy60 in 1 BOTTLETABLET, FILM COATED609
41163-458-76Equaline all day allergy120 in 1 BOTTLETABLET, FILM COATED1209
41163-458-76Equaline all day allergy1 in 1 CARTONTABLET, FILM COATED19
41163-458-95Equaline all day allergy1 in 1 PACKAGETABLET, FILM COATED19
41163-458-95Equaline all day allergy45 in 1 BOTTLETABLET, FILM COATED459

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-458EQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]8Current NDC, Legacy NDC, 12 package rows20230803_491fae66-83b6-4beb-945b-39b9e4e021c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN491fae66-83b6-4beb-945b-39b9e4e021c59
1014678cetirizine hydrochloride 10 MG Oral TabletSCD491fae66-83b6-4beb-945b-39b9e4e021c59
1014678cetirizine HCl 10 MG Oral TabletSY491fae66-83b6-4beb-945b-39b9e4e021c59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-458-39411630458391 BOTTLE in 1 CARTON (41163-458-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-11-030000-00-00NoNoCurrent
41163-458-58411630458581 BOTTLE in 1 CARTON (41163-458-58) > 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-11-210000-00-00NoNoCurrent
41163-458-664116304586614 BLISTER PACK in 1 CARTON (41163-458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK14 blister pack2008-01-230000-00-00NoNoCurrent
41163-458-72411630458721 BOTTLE in 1 CARTON (41163-458-72) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-09-090000-00-00NoNoCurrent
41163-458-76411630458761 BOTTLE in 1 CARTON (41163-458-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-08-050000-00-00NoNoCurrent
41163-458-95411630458951 in 1 PACKAGEHistorical