FDA.reportPublic FDA data

Allergy Relief

Product NDC
72476-064
11-digit product format
724760064
Labeler code
72476
Product ID
72476-064_e3d08c78-89a2-4185-8e6f-07fbdc018254
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Care One (Retail Business Services, LLC.)
Application
ANDA213105
Marketing category
ANDA
Marketing start
2018-04-30
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
Rxcui1014675

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-064-25Allergy Relief1 in 1 BOXCAPSULE12
72476-064-25Allergy Relief25 in 1 BOTTLE, PLASTICCAPSULE252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-064ALLERGY RELIEF (CETIRIZINE HCL) CAPSULE [CARE ONE (RETAIL BUSINESS SERVICES, LLC.)]2Current NDC, Legacy NDC, 2 package rows20221021_04a6087e-d854-4e70-9d89-3971890a44a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN04a6087e-d854-4e70-9d89-3971890a44a32
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD04a6087e-d854-4e70-9d89-3971890a44a32
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY04a6087e-d854-4e70-9d89-3971890a44a32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72476-064-25724760064251 BOTTLE, PLASTIC in 1 BOX (72476-064-25) / 25 CAPSULE in 1 BOTTLE, PLASTIC2018-04-300000-00-00NoNoCurrent