FDA.reportPublic FDA data

ALLERGY RELIEF

Product NDC
72476-194
11-digit product format
724760194
Labeler code
72476
Product ID
72476-194_c6f31728-fdb8-f78d-e053-2a95a90a253e
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
RETAIL BUSINESS SERVICES , LLC.
Application
ANDA209274
Marketing category
ANDA
Marketing start
2020-07-01
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
72476-194-01ALLERGY RELIEF1 in 1 CARTONTABLET, COATED13
72476-194-01ALLERGY RELIEF14 in 1 BOTTLE, PLASTICTABLET, COATED143
72476-194-13ALLERGY RELIEF2 in 1 CARTONTABLET, COATED23
72476-194-13ALLERGY RELIEF90 in 1 BOTTLE, PLASTICTABLET, COATED903
72476-194-14ALLERGY RELIEF1 in 1 PACKAGETABLET, COATED13
72476-194-14ALLERGY RELIEF30 in 1 BOTTLE, PLASTICTABLET, COATED303
72476-194-15ALLERGY RELIEF1 in 1 CARTONTABLET, COATED13
72476-194-15ALLERGY RELIEF70 in 1 BOTTLE, PLASTICTABLET, COATED703
72476-194-16ALLERGY RELIEF90 in 1 BOTTLE, PLASTICTABLET, COATED903
72476-194-16ALLERGY RELIEF1 in 1 CARTONTABLET, COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-194ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, COATED [RETAIL BUSINESS SERVICES , LLC.]3Current NDC, Legacy NDC, 10 package rows20210713_95bf367c-eea8-73f9-e053-2a95a90a3dea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN95bf367c-eea8-73f9-e053-2a95a90a3dea3
1014678cetirizine hydrochloride 10 MG Oral TabletSCD95bf367c-eea8-73f9-e053-2a95a90a3dea3
1014678cetirizine HCl 10 MG Oral TabletSY95bf367c-eea8-73f9-e053-2a95a90a3dea3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72476-194-01724760194011 BOTTLE, PLASTIC in 1 CARTON (72476-194-01) / 14 TABLET, COATED in 1 BOTTLE, PLASTIC2020-07-010000-00-00NoNoCurrent
72476-194-13724760194132 BOTTLE, PLASTIC in 1 CARTON (72476-194-13) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC2021-07-060000-00-00NoNoCurrent
72476-194-14724760194141 BOTTLE, PLASTIC in 1 PACKAGE (72476-194-14) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC2020-07-010000-00-00NoNoCurrent
72476-194-15724760194151 BOTTLE, PLASTIC in 1 CARTON (72476-194-15) / 70 TABLET, COATED in 1 BOTTLE, PLASTIC2020-07-010000-00-00NoNoCurrent
72476-194-16724760194161 BOTTLE, PLASTIC in 1 CARTON (72476-194-16) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC2020-07-010000-00-00NoNoCurrent