Allergy Relief

Product NDC
54257-270
11-digit product format
542570270
Labeler code
54257
Product ID
54257-270_cf6d242a-ce61-23b7-e053-2a95a90a856c
Type
HUMAN OTC DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Magno-Humphries, Inc.
Application
ANDA209274
Marketing category
ANDA
Marketing start
2020-01-24
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
54257-270-02Allergy Relief100 in 1 BOTTLETABLET1003
54257-270-05Allergy Relief500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54257-270ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [MAGNO-HUMPHRIES, INC.]3Current NDC, Legacy NDC, 2 package rows20211030_f0a3e654-5fec-4f98-84da-4c30500633b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNf0a3e654-5fec-4f98-84da-4c30500633b43
1014678cetirizine hydrochloride 10 MG Oral TabletSCDf0a3e654-5fec-4f98-84da-4c30500633b43
1014678cetirizine HCl 10 MG Oral TabletSYf0a3e654-5fec-4f98-84da-4c30500633b43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54257-270-0254257027002100 TABLET in 1 BOTTLE (54257-270-02) 100 tablet2020-01-240000-00-00NoNoCurrent
54257-270-0554257027005500 TABLET in 1 BOTTLE (54257-270-05) 500 tablet2020-01-240000-00-00NoNoCurrent