Allergy Relief

Product NDC
41163-197
11-digit product format
411630197
Labeler code
41163
Product ID
41163-197_fbe573b2-eb20-af53-e053-6394a90a2dc9
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA209274
Marketing category
ANDA
Marketing start
2020-10-22
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
41163-197-08Allergy Relief120 in 1 BOTTLE, PLASTICTABLET, COATED1204
41163-197-08Allergy Relief1 in 1 CARTONTABLET, COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-197ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, COATED [UNITED NATURAL FOODS, INC. DBA UNFI]4Current NDC, Legacy NDC, 2 package rows20230519_adcd0e8e-cca7-e1bb-e053-2995a90a83be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNadcd0e8e-cca7-e1bb-e053-2995a90a83be4
1014678cetirizine hydrochloride 10 MG Oral TabletSCDadcd0e8e-cca7-e1bb-e053-2995a90a83be4
1014678cetirizine HCl 10 MG Oral TabletSYadcd0e8e-cca7-e1bb-e053-2995a90a83be4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41163-197-08411630197081 BOTTLE, PLASTIC in 1 CARTON (41163-197-08) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC2020-10-220000-00-00NoNoCurrent